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CompletedNCT01484561Updated Apr 2, 2014Results posted

A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis

A Phase 1 interventional study of CP-690,550 or Placebo and Placebo in Arthritis, Rheumatoid, sponsored by Pfizer. Completed at 24 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-02.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of study is to explore the effect of CP-690,550 (Tofacitinib) on measures of kidney function in patients with active rheumatoid arthritis (RA).

02

Conditions studied

  • Arthritis, Rheumatoid

Keywords

  • Phase 1
03

In context

Arthritis, Rheumatoid

2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 148 is above the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The patient must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of rheumatoid arthritis by satisfying at least four of the seven criteria.
  • The patient must have active disease at both Screening and predose on Day 1 of Period 1.
  • Patient must have had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD), non-biologic or biologic, due to ineffectiveness or intolerance.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women
  • Serious medical conditions that would make treatment with CP-690,550 potentially unsafe.
  • A patient who has a history of asthma, multiple allergies or severe allergy (eg, anaphylaxis) to any substance. In particular, a history of allergy to iodine, povidone-iodine, iohexol or other iodinated contrast media.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
148 participants (actual)

Study arms

  • Active comparator
    Sequence 1

    Drug: CP-690,550 or Placebo

  • Placebo comparator
    Sequence 2

    Drug: Placebo

Interventions

  • DrugCP-690,550 or Placebo

    CP-690,550 10 mg twice a day (BID) orally or placebo BID orally, approximately 72 days

  • DrugPlacebo

    Placebo BID orally, approximately 72 days

06

What researchers measure

Primary outcomes

  1. Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)

    Glomerular filtration rate (GFR) is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 meters squared (m\^2) body surface area. A normal GFR is greater than (\>)90 milliliters per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR \<15 mL/min is consistent with kidney failure. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.

    Time frame: Day 1 of Period 1, Day 43 of Period 1

Secondary outcomes

  1. Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR

    mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.

    Time frame: Day 1 of Period 1, Day 29 of Period 2

  2. Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR

    mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m\^2 body surface area.

    Time frame: Day 43 of Period 1, Day 29 of Period 2

  3. Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD)

    eGFR was calculated using the MDRD equation and normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.

    Time frame: Day 1 of Period 1, Day 43 of Period 1

  4. Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD

    eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.

    Time frame: Day 1 of Period 1, Day 29 of Period 2

  5. Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD

    eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m\^2 body surface area.

    Time frame: Day 43 of Period 1, Day 29 of Period 2

  6. Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation

    eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.

    Time frame: Day 1 of Period 1, Day 43 of Period 1

  7. Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation

    eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.

    Time frame: Day 1 of Period 1, Day 29 of Period 2

  8. Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation

    eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m\^2 body surface area.

    Time frame: Day 43 of Period 1, Day 29 of Period 2

  9. Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine

    Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in milligrams per deciliter (mg/dL) reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.

    Time frame: Day 1 of Period 1, Day 43 of Period 1

  10. Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine

    Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.

    Time frame: Day 1 of Period 1, Day 29 of Period 2

  11. Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine

    Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used.

    Time frame: Day 43 of Period 1, Day 29 of Period 2

  12. Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response

    ACR20 response: greater than or equal to (≥)20 percent (%) improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

    Time frame: Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2

  13. Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

    ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.

    Time frame: Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2

  14. Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

    ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant' assessment of functional disability via a HAQ, and 5) CRP at each visit.

    Time frame: Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2

  15. Least Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP])

    DAS28 calculated from the tender/painful joint count, swollen joint count (SJC) using the 28 joints count, and CRP value. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.

    Time frame: Day 1 of Period 1, Day 43 of Period 1

  16. LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP)

    DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

    Time frame: Day 1 of Period 1, Day 29 of Period 2

  17. LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP)

    DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

    Time frame: Day 43 of Period 1, Day 29 of Period 2

  18. LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP)

    DAS28 calculated from the number of SJC and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

    Time frame: Day 1 of Period 1, Day 43 of Period 1

  19. LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP)

    DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

    Time frame: Day 1 of Period 1, Day 29 of Period 2

  20. LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP)

    DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

    Time frame: Day 43 of Period 1, Day 29 of Period 2

  21. LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count

    68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb interphalangeal \[IP\], PIP, and distal interphalangeals \[DIP\]), and lower extremity (hip, knee, ankle, tarsus, metatarsophalangeals \[MTP\], great toe IP, proximal and distal interphalangeals combined \[PIP\]).

    Time frame: Day 1 of Period 1, Day 43 of Period 1

  22. LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count

    68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

    Time frame: Day 1 of Period 1, Day 29 of Period 2

  23. LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count

    68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

    Time frame: Day 43 of Period 1, Day 29 of Period 2

  24. LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count

    Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

    Time frame: Day 1 of Period 1, Day 43 of Period 1

  25. LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count

    Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

    Time frame: Day 1 of Period 1, Day 29 of Period 2

  26. LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count

    Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

    Time frame: Day 43 of Period 1, Day 29 of Period 2

  27. LS Mean Change at End of Period 1 From Baseline in CRP

    Time frame: Day 1 of Period 1, Day 43 of Period 1

  28. LS Mean Change at End of Period 2 From Baseline in CRP

    Time frame: Day 1 of Period 1, Day 29 of Period 2

  29. LS Mean Change at End of Period 2 From End of Period 1 in CRP

    Time frame: Day 43 of Period 1, Day 29 of Period 2

  30. LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA)

    Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very well and 100 mm = very poorly.

    Time frame: Day 1 of Period 1, Day 43 of Period 1

  31. LS Mean Change at End of Period 2 From Baseline in PGAA

    Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

    Time frame: Day 1 of Period 1, Day 29 of Period 2

  32. LS Mean Change at End of Period 2 From End of Period 1 in PGAA

    Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

    Time frame: Day 43 of Period 1, Day 29 of Period 2

  33. LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis

    A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.

    Time frame: Day 1 of Period 1, Day 43 of Period 1

  34. LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis

    A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.

    Time frame: Day 1 of Period 1, Day 29 of Period 2

  35. LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis

    A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.

    Time frame: Day 43 of Period 1, Day 29 of Period 1

  36. LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain

    Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

    Time frame: Day 1 of Period 1, Day 43 of Period 1

  37. LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain

    Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

    Time frame: Day 1 of Period 1, Day 29 of Period 2

  38. LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain

    Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

    Time frame: Day 43 of Period 2, Day 29 of Period 2

  39. LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score

    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

    Time frame: Day 1 of Period 1, Day 43 of Period 1

  40. LS Mean Change at End of Period 2 From Baseline HAQ-DI Score

    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

    Time frame: Day 1 of Period 1, Day 29 of Period 2

  41. LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score

    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

    Time frame: Day 43 of Period 1, Day 29 of Period 2

07

Results

Posted Apr 2, 2014

Participant flow

Participant flow — Overall Study
MilestoneCP-690,550/PlaceboPlacebo/Placebo
Started9751
Completed8845
Not completed96
Withdrew: Lack of efficacy31
Withdrew: Lost to follow-up10
Withdrew: Withdrawal by subject30
Withdrew: Other11
Withdrew: Adverse event14

Outcome measures

PrimaryAdjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)

Glomerular filtration rate (GFR) is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 meters squared (m\^2) body surface area. A normal GFR is greater than (\>)90 milliliters per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR \<15 mL/min is consistent with kidney failure. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.

Time frame:
Day 1 of Period 1, Day 43 of Period 1
Reported as:
Geometric mean · fold change
Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)
fold changeCP-690,550/PlaceboPlacebo/Placebo
Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)0.91 (0.88 to 0.95)0.99 (0.94 to 1.04)
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · ANCOVA · Ratio of adjusted geo mean-fold change: 0.92 · 90% CI 0.86 to 0.98Analysis of covariance (ANCOVA) with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.
SecondaryAdjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR

mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.

Time frame:
Day 1 of Period 1, Day 29 of Period 2
Reported as:
Geometric mean · fold change
Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR
fold changeCP-690,550/PlaceboPlacebo/Placebo
Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR0.96 (0.92 to 1.00)0.92 (0.87 to 0.97)
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · ANCOVA · Ratio of adjusted geo mean-fold change: 1.04 · 90% CI 0.97 to 1.11ANCOVA with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.
SecondaryAdjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR

mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m\^2 body surface area.

Time frame:
Day 43 of Period 1, Day 29 of Period 2
Reported as:
Geometric mean · fold change
Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR
fold changeCP-690,550/PlaceboPlacebo/Placebo
Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR1.03 (0.99 to 1.07)0.95 (0.90 to 0.99)
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · ANCOVA · Ratio of adjusted geo mean-fold change: 1.09 · 90% CI 1.02 to 1.16ANCOVA with change in logarithmic mGFR from Period 2 baseline/the end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/the end of Period 1 as covariate.
SecondaryAdjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD)

eGFR was calculated using the MDRD equation and normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.

Time frame:
Day 1 of Period 1, Day 43 of Period 1
Reported as:
Geometric mean · fold change
Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD)
fold changeCP-690,550/PlaceboPlacebo/Placebo
Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD)0.96 (0.94 to 0.97)1.01 (0.99 to 1.04)
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · ANCOVA · Ratio of adjusted geo mean-fold change: 0.94 · 90% CI 0.91 to 0.97ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.
SecondaryAdjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD

eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.

Time frame:
Day 1 of Period 1, Day 29 of Period 2
Reported as:
Geometric mean · fold change
Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD
fold changeCP-690,550/PlaceboPlacebo/Placebo
Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD0.99 (0.98 to 1.01)1.01 (0.98 to 1.03)
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · ANCOVA · Ratio of adjusted geo mean-fold change: 0.99 · 90% CI 0.96 to 1.02ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.
SecondaryAdjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD

eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m\^2 body surface area.

Time frame:
Day 43 of Period 1, Day 29 of Period 2
Reported as:
Geometric mean · fold change
Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD
fold changeCP-690,550/PlaceboPlacebo/Placebo
Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD1.04 (1.02 to 1.06)1.00 (0.97 to 1.03)
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · ANCOVA · Ratio of adjusted geo mean-fold change: 1.04 · 90% CI 1.00 to 1.08ANCOVA with change in logarithmic eGFR (MDRD) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.
SecondaryAdjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation

eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.

Time frame:
Day 1 of Period 1, Day 43 of Period 1
Reported as:
Geometric mean · fold change
Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation
fold changeCP-690,550/PlaceboPlacebo/Placebo
Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation0.96 (0.95 to 0.98)1.01 (0.99 to 1.04)
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · ANCOVA · Ratio of adjusted geo mean-fold change: 0.95 · 90% CI 0.92 to 0.98ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.
SecondaryAdjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation

eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m\^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.

Time frame:
Day 1 of Period 1, Day 29 of Period 2
Reported as:
Geometric mean · fold change
Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation
fold changeCP-690,550/PlaceboPlacebo/Placebo
Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation1.00 (0.98 to 1.01)1.01 (0.98 to 1.03)
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · ANCOVA · Ratio of adjusted geo mean-fold change: 0.99 · 90% CI 0.97 to 1.02ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.
SecondaryAdjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation

eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m\^2 body surface area.

Time frame:
Day 43 of Period 1, Day 29 of Period 2
Reported as:
Geometric mean · fold change
Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation
fold changeCP-690,550/PlaceboPlacebo/Placebo
Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation1.03 (1.01 to 1.05)1.00 (0.97 to 1.02)
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · ANCOVA · Ratio of adjusted geo mean-fold change: 1.04 · 90% CI 1.01 to 1.07ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.
SecondaryAdjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine

Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in milligrams per deciliter (mg/dL) reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.

Time frame:
Day 1 of Period 1, Day 43 of Period 1
Reported as:
Geometric mean · fold change
Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine
fold changeCP-690,550/PlaceboPlacebo/Placebo
Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine1.04 (1.02 to 1.06)0.99 (0.97 to 1.01)
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · ANCOVA · Ratio of adjusted geo mean-fold change: 1.05 · 90% CI 1.02 to 1.08ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.
SecondaryAdjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine

Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.

Time frame:
Day 1 of Period 1, Day 29 of Period 2
Reported as:
Geometric mean · fold change
Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine
fold changeCP-690,550/PlaceboPlacebo/Placebo
Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine1.00 (0.99 to 1.02)1.00 (0.97 to 1.02)
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · ANCOVA · Ratio of adjusted geo mean-fold change: 1.01 · 90% CI 0.98 to 1.04ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.
SecondaryAdjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine

Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used.

Time frame:
Day 43 of Period 1, Day 29 of Period 2
Reported as:
Geometric mean · fold change
Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine
fold changeCP-690,550/PlaceboPlacebo/Placebo
Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine0.97 (0.95 to 0.99)1.00 (0.98 to 1.03)
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · ANCOVA · Ratio of adjusted geo mean-fold change: 0.97 · 90% CI 0.94 to 1.00ANCOVA with change in logarithmic creatinine from Period 2 baseline/the end of Period 1 as dependent variable, treatment and Period 2 baseline/the end of Period 1 as covariate.
SecondaryPercentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response

ACR20 response: greater than or equal to (≥)20 percent (%) improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Time frame:
Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2
Reported as:
Number · percentage of participants
Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response
percentage of participantsCP-690,550/PlaceboPlacebo/Placebo
End of Period 1 (Day 43)57.7321.57
End of Period 2 (Day 29)45.3629.41
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Normal approximation for proportions · p = <0.001 (Two-sided test at 5% significance level.) · Mean difference (final values): 36.16 · 90% CI 23.60 to 48.73
  • CP-690,550/Placebo vs Placebo/Placebo · Normal approximation for proportions · p = 0.050 (Two-sided test at 5% significance level.) · Mean difference (final values): 15.95 · 90% CI 2.56 to 29.34
SecondaryPercentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.

Time frame:
Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2
Reported as:
Number · percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
percentage of participantsCP-690,550/PlaceboPlacebo/Placebo
End of Period 1 (Day 43)28.877.84
End of Period 2 (Day 29)26.809.80
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Normal approximation for proportions · p = <0.001 (Two-sided test at 5% significance level.) · Mean difference (final values): 21.02 · 90% CI 11.24 to 30.80
  • CP-690,550/Placebo vs Placebo/Placebo · Normal approximation for proportions · p = 0.006 (Two-sided test at 5% significance level.) · Mean difference (final values): 17.00 · 90% CI 6.92 to 27.08
SecondaryPercentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant' assessment of functional disability via a HAQ, and 5) CRP at each visit.

Time frame:
Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2
Reported as:
Number · percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
percentage of participantsCP-690,550/PlaceboPlacebo/Placebo
End of Period 1 (Day 43)18.560.00
End of Period 2 (Day 29)9.281.96
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Normal approximation for proportions · p = <0.001 (Two-sided test at 5% significance level.) · Mean difference (final values): 18.56 · 90% CI 12.06 to 25.05
  • CP-690,550/Placebo vs Placebo/Placebo · Normal approximation for proportions · p = 0.038 (Two-sided test at 5% significance level.) · Mean difference (final values): 7.32 · 90% CI 1.51 to 13.12
SecondaryLeast Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP])

DAS28 calculated from the tender/painful joint count, swollen joint count (SJC) using the 28 joints count, and CRP value. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.

Time frame:
Day 1 of Period 1, Day 43 of Period 1
Reported as:
Least squares mean · score on a scale
Least Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP])
score on a scaleCP-690,550/PlaceboPlacebo/Placebo
Least Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP])-1.71 ± 0.13-0.55 ± 0.19
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = <0.001 (Two-sided test at 5% significance level.) · Mean difference (final values): -1.16 · 90% CI -1.53 to -0.78Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP)

DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

Time frame:
Day 1 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · score on a scale
LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP)
score on a scaleCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP)-1.36 ± 0.12-0.89 ± 0.17
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.028 (Two-sided test at 5% significance level.) · Mean difference (final values): -0.47 · 90% CI -0.83 to -0.12Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP)

DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

Time frame:
Day 43 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · score on a scale
LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP)
score on a scaleCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP)0.35 ± 0.12-0.34 ± 0.18
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.002 (Two-sided test at 5% significance level.) · Mean difference (final values): 0.68 · 90% CI 0.32 to 1.04Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP)

DAS28 calculated from the number of SJC and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

Time frame:
Day 1 of Period 1, Day 43 of Period 1
Reported as:
Least squares mean · score on a scale
LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP)
score on a scaleCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP)-1.88 ± 0.14-0.62 ± 0.21
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = <0.001 (Two-sided test at 5% significance level.) · Mean difference (final values): -1.26 · 90% CI -1.67 to -0.84Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP)

DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

Time frame:
Day 1 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · score on a scale
LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP)
score on a scaleCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP)-1.46 ± 0.13-0.96 ± 0.19
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.031 (Two-sided test at 5% significance level.) · Mean difference (final values): -0.50 · 90% CI -0.88 to -0.12Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP)

DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.

Time frame:
Day 43 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · score on a scale
LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP)
score on a scaleCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP)0.42 ± 0.14-0.34 ± 0.20
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.002 (Two-sided test at 5% significance level.) · Mean difference (final values): 0.76 · 90% CI 0.36 to 1.15Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count

68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb interphalangeal \[IP\], PIP, and distal interphalangeals \[DIP\]), and lower extremity (hip, knee, ankle, tarsus, metatarsophalangeals \[MTP\], great toe IP, proximal and distal interphalangeals combined \[PIP\]).

Time frame:
Day 1 of Period 1, Day 43 of Period 1
Reported as:
Least squares mean · tender/painful joints
LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count
tender/painful jointsCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count-9.88 ± 1.16-5.79 ± 1.66
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.045 (Two-sided test at 5% significance level.) · Mean difference (final values): -4.09 · 90% CI -7.44 to -0.74Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count

68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

Time frame:
Day 1 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · tender/painful joints
LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count
tender/painful jointsCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count-8.13 ± 1.02-8.27 ± 1.44
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.936 (Two-sided test at 5% significance level.) · Mean difference (final values): 0.14 · 90% CI -2.78 to 3.06Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count

68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

Time frame:
Day 43 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · tender/painful joints
LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count
tender/painful jointsCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count1.75 ± 1.11-2.48 ± 1.58
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.030 (Two-sided test at 5% significance level.) · Mean difference (final values): 4.23 · 90% CI 1.04 to 7.42Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 1 From Baseline in Swollen Joint Count

Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

Time frame:
Day 1 of Period 1, Day 43 of Period 1
Reported as:
Least squares mean · swollen joints
LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count
swollen jointsCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count-7.07 ± 0.59-4.81 ± 0.84
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.030 (Two-sided test at 5% significance level.) · Mean difference (final values): -2.26 · 90% CI -3.96 to -0.55Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From Baseline in Swollen Joint Count

Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

Time frame:
Day 1 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · swollen joints
LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count
swollen jointsCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count-6.63 ± 0.64-5.83 ± 0.91
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.472 (Two-sided test at 5% significance level.) · Mean difference (final values): -0.80 · 90% CI -2.64 to 1.04Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count

Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined \[PIP\]).

Time frame:
Day 43 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · swollen joints
LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count
swollen jointsCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count0.43 ± 0.59-1.02 ± 0.84
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.158 (Two-sided test at 5% significance level.) · Mean difference (final values): 1.46 · 90% CI -0.24 to 3.15Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 1 From Baseline in CRP
Time frame:
Day 1 of Period 1, Day 43 of Period 1
Reported as:
Least squares mean · mg/L
LS Mean Change at End of Period 1 From Baseline in CRP
mg/LCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 1 From Baseline in CRP-13.81 ± 2.17-0.08 ± 3.01
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = <0.001 (Two-sided test at 5% significance level.) · Mean difference (final values): -13.73 · 90% CI -19.87 to -7.59Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From Baseline in CRP
Time frame:
Day 1 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · mg/L
LS Mean Change at End of Period 2 From Baseline in CRP
mg/LCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From Baseline in CRP-8.37 ± 2.340.53 ± 3.29
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.029 (Two-sided test at 5% significance level.) · Mean difference (final values): -8.89 · 90% CI -15.58 to -2.21Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From End of Period 1 in CRP
Time frame:
Day 43 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · mg/L
LS Mean Change at End of Period 2 From End of Period 1 in CRP
mg/LCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From End of Period 1 in CRP5.44 ± 1.710.61 ± 2.44
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.107 (Two-sided test at 5% significance level.) · Mean difference (final values): 4.84 · 90% CI -0.10 to 9.77Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA)

Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very well and 100 mm = very poorly.

Time frame:
Day 1 of Period 1, Day 43 of Period 1
Reported as:
Least squares mean · mm
LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA)
mmCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA)-23.28 ± 2.81-7.38 ± 3.98
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.001 (Two-sided test at 5% significance level.) · Mean difference (final values): -15.90 · 90% CI -23.96 to -7.84Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From Baseline in PGAA

Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

Time frame:
Day 1 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · mm
LS Mean Change at End of Period 2 From Baseline in PGAA
mmCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From Baseline in PGAA-16.12 ± 2.87-10.41 ± 4.03
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.251 (Two-sided test at 5% significance level.) · Mean difference (final values): -5.70 · 90% CI -13.90 to 2.50Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From End of Period 1 in PGAA

Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

Time frame:
Day 43 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · mm
LS Mean Change at End of Period 2 From End of Period 1 in PGAA
mmCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From End of Period 1 in PGAA7.16 ± 2.54-3.03 ± 3.62
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.023 (Two-sided test at 5% significance level.) · Mean difference (final values): 10.19 · 90% CI 2.87 to 17.52Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis

A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.

Time frame:
Day 1 of Period 1, Day 43 of Period 1
Reported as:
Least squares mean · mm
LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis
mmCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis-29.83 ± 2.24-14.71 ± 3.19
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = <0.001 (Two-sided test at 5% significance level.) · Mean difference (final values): -15.12 · 90% CI -21.58 to -8.67Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis

A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.

Time frame:
Day 1 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · mm
LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis
mmCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis-24.61 ± 2.76-22.21 ± 3.89
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.616 (Two-sided test at 5% significance level.) · Mean difference (final values): -2.40 · 90% CI -10.30 to 5.50Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis

A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.

Time frame:
Day 43 of Period 1, Day 29 of Period 1
Reported as:
Least squares mean · mm
LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis
mmCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis5.22 ± 2.39-7.50 ± 3.41
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.003 (Two-sided test at 5% significance level.) · Mean difference (final values): 12.72 · 90% CI 5.82 to 19.62Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain

Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

Time frame:
Day 1 of Period 1, Day 43 of Period 1
Reported as:
Least squares mean · mm
LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain
mmCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain-23.53 ± 2.61-8.23 ± 3.69
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = <0.001 (Two-sided test at 5% significance level.) · Mean difference (final values): -15.30 · 90% CI -22.78 to -7.82Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain

Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

Time frame:
Day 1 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · mm
LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain
mmCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain-14.70 ± 2.80-9.08 ± 3.94
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.247 (Two-sided test at 5% significance level.) · Mean difference (final values): -5.62 · 90% CI -13.62 to 2.38Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain

Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.

Time frame:
Day 43 of Period 2, Day 29 of Period 2
Reported as:
Least squares mean · mm
LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain
mmCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain8.83 ± 2.69-0.85 ± 3.81
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.040 (Two-sided test at 5% significance level.) · Mean difference (final values): 9.68 · 90% CI 1.95 to 17.41Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Time frame:
Day 1 of Period 1, Day 43 of Period 1
Reported as:
Least squares mean · score on a scale
LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score
score on a scaleCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score-0.44 ± 0.06-0.04 ± 0.08
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = <0.001 (Two-sided test at 5% significance level.) · Mean difference (final values): -0.39 · 90% CI -0.56 to -0.23Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From Baseline HAQ-DI Score

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Time frame:
Day 1 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · score on a scale
LS Mean Change at End of Period 2 From Baseline HAQ-DI Score
score on a scaleCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From Baseline HAQ-DI Score-0.34 ± 0.05-0.17 ± 0.07
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.053 (Two-sided test at 5% significance level.) · Mean difference (final values): -0.17 · 90% CI -0.31 to -0.03Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect
SecondaryLS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Time frame:
Day 43 of Period 1, Day 29 of Period 2
Reported as:
Least squares mean · score on a scale
LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score
score on a scaleCP-690,550/PlaceboPlacebo/Placebo
LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score0.09 ± 0.04-0.13 ± 0.06
Statistical analysis
  • CP-690,550/Placebo vs Placebo/Placebo · Mixed Models Analysis · p = 0.003 (Two-sided test at 5% significance level.) · Mean difference (final values): 0.22 · 90% CI 0.10 to 0.35Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CP-690,550/Placebo—2/97 (2.1%)32/97 (33%)
Placebo/Placebo—0/51 (0%)26/51 (51%)
Most frequent serious events
Most frequent serious events
EventCP-690,550/PlaceboPlacebo/Placebo
BronchopneumoniaInfections and infestations1/970/51
Pelvic fractureInjury, poisoning and procedural complications1/970/51
Most frequent other events
Showing 10 of 40
Most frequent other events
EventCP-690,550/PlaceboPlacebo/Placebo
NasopharyngitisInfections and infestations8/973/51
HeadacheNervous system disorders6/971/51
Gastrooesophageal reflux diseaseGastrointestinal disorders0/973/51
NauseaGastrointestinal disorders5/972/51
Urinary tract infectionInfections and infestations3/972/51
Abdominal pain upperGastrointestinal disorders3/970/51
VomitingGastrointestinal disorders2/970/51
Oral herpesInfections and infestations2/970/51
Alanine aminotransferase increasedInvestigations2/970/51
Blood creatine phosphokinase increasedInvestigations2/970/51

Baseline characteristics

Age, Continuous
Age, Continuous(years)CP-690,550/PlaceboPlacebo/PlaceboTotal
Mean51.9 ± 12.747.3 ± 11.850.3 ± 12.6
Sex: Female, Male
Sex: Female, Male(Participants)CP-690,550/PlaceboPlacebo/PlaceboTotal
Female7536111
Male221537
08

Study locations

24 sites
  • Pfizer Investigational Site
    South Miami, Florida 33143, United States
  • Pfizer Investigational Site
    Albany, New York 12206, United States
  • Pfizer Investigational Site
    Duncansville, Pennsylvania 16635, United States
  • Pfizer Investigational Site
    Dallas, Texas 75231, United States
  • Pfizer Investigational Site
    Tacoma, Washington 98405, United States
  • Pfizer Investigational Site
    Prague, 140 59, Czechia
  • Pfizer Investigational Site
    Berlin, 13125, Germany
  • Pfizer Investigational Site
    Erlangen, 91054, Germany
  • Pfizer Investigational Site
    Würzburg, 97080, Germany
  • Pfizer Investigational Site
    Mérida, Yucatán 97000, Mexico
  • Pfizer Investigational Site
    Bialystok, 15-354, Poland
  • Pfizer Investigational Site
    Bydgoszcz, 85-168, Poland
  • Pfizer Investigational Site
    Warsaw, 01-192, Poland
  • Pfizer Investigational Site
    Warsaw, 02-256, Poland
  • Pfizer Investigational Site
    Wroclaw, 50-088, Poland
  • Pfizer Investigational Site
    Moscow, 115522, Russia
  • Pfizer Investigational Site
    Petrozavodsk, 185019, Russia
  • Pfizer Investigational Site
    Saint Petersburg, 194291, Russia
  • Pfizer Investigational Site
    Saint Petersburg, 197341, Russia
  • Pfizer Investigational Site
    Seoul, 120-752, South Korea
  • Pfizer Investigational Site
    Seville, Sevilla 41009, Spain
  • Pfizer Investigational Site
    Barakaldo, Vizcaya 48903, Spain
  • Pfizer Investigational Site
    Bilbao, Vizcaya 48013, Spain
  • Pfizer Investigational Site
    A Coruña, 15006, Spain
09

References and documents

Publications

  • Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17. PubMed 36931693 ↗
  • Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022. PubMed 36601090 ↗
  • Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5. PubMed 36600185 ↗
  • Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17. PubMed 36526796 ↗
  • Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6. PubMed 34870800 ↗
  • Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395. PubMed 33127856 ↗
  • Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. PubMed 32816215 ↗
  • Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31. PubMed 28143815 ↗
  • Kremer JM, Kivitz AJ, Simon-Campos JA, Nasonov EL, Tony HP, Lee SK, Vlahos B, Hammond C, Bukowski J, Li H, Schulman SL, Raber S, Zuckerman A, Isaacs JD. Evaluation of the effect of tofacitinib on measured glomerular filtration rate in patients with active rheumatoid arthritis: results from a randomised controlled trial. Arthritis Res Ther. 2015 Apr 6;17(1):95. doi: 10.1186/s13075-015-0612-7. PubMed 25889308 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01484561
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Dec 2, 2011
Start date
Apr 2012
Primary completion
Jan 2013
Completion
Feb 2013
Results posted
Apr 2, 2014
Last update
Apr 2, 2014

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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