An observational study in Arthritis, Rheumatoid, sponsored by Pfizer. Completed at 91 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Pfizer · Observational
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Among 152 studies in Arthritis, Rheumatoid by Pfizer — 2 open to participants now, 2 under way, none of them phase 3. Arthritis, Rheumatoid · Pfizer.
Among the 152 studies in Arthritis, Rheumatoid by Pfizer, this one is the 16th largest by enrollment of the 63 observational ones that give a count, is one of 3 that started in 2017, is one of 64 observational ones, and was the 127th registered.
3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.
Browse Arthritis, Rheumatoid studies →2 of the 152 studies in Arthritis, Rheumatoid by Pfizer are open now, in 1 country. Recruiting first, the newest first:
Pfizer · Sites in Korea, Republic of
Ages 18+
Pfizer
Ages 18–70
By country, each count listing its studies:
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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152 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 29 · Phase 3 18 · Phase 4 17
First in 2003; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,459 is above the median of 176 across 1,017 observational studies indexed under Arthritis, Rheumatoid.
Median enrollment 155 across the 86 interventional studies, 421 across the 63 observational. Of the 149 that completed or were terminated, 105 (70%) have results posted.
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Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 152 studies in Arthritis, Rheumatoid by Pfizer, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This non-interventional study aims to identify key factors that are driving treatment decisions by rheumatologists in the treatment of rheumatoid arthritis (RA) patients starting treatment with Tofacitinib in a real world setting.
Adult patients with confirmed diagnosis of rheumatoid arthritis who are eligible for treatment with Tofacitinb according to Summary of Product Characteristics (SmPC)
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.
Patients aged ≥ 18 years
Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist
Patient is eligible for Tofacitinib treatment according to Summary of Product Characteristics (SmPC)
Evidence of a personally signed and dated document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria:
according to Xeljanz® SmPC
Receipt of any drug within 3 months before study inclusion
Patients who have received any previous treatment with Tofacitinib or other JAK inhibitors
Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who are started on Tofacitinib treatment according to the drug label
Number of Participants With Treatment Escalations
Treatment escalations was defined as participants who switched to another disease modifying antirheumatic drug (DMARD) or combination of DMARDs when compared to the last visit. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime towards e.g.a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, example (e.g.) from combination therapy to monotherapy. One participant can fall into more than 1 type of escalation.
Time frame: From date of first prescription of tofacitinib up to 24 Months
Time to Treatment Escalation
Time to treatment escalation was defined as time in days from escalation visit date to next escalation visit date. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, e.g. from combination therapy to monotherapy. Number of participants with total number of each type of treatment escalations during the study (step-up/switch, step-down, treatment termination along with all escalations) are reported in this outcome measure.
Time frame: From date of first prescription of tofacitinib up to 24 Months
Time to First Step Up Treatment Escalation
Time to first step-up treatment escalation was defined for participants who experienced a treatment step-up and was measured as date of first treatment step up escalation minus (-) date of first prescription of tofacitinib. Treatment step-up was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs.
Time frame: From date of first tofacitinib prescription up to date of first step-up treatment escalation (maximum up to 24 months)
Number of Participants Achieving Low Disease Activity (LDA) as Assessed by Simplified Disease Activity Index (SDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24
SDAI was calculated using the following formula: SDAI = Tender Joint Count (TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 centimetre \[cm\] scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + C-reactive protein (CRP) (milligram per decilitre \[mg/dL\]). TJC28 joints included shoulders, elbows, wrists, metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm visual analogue scale (VAS) scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of less than or equal to (\<=11) indicates LDA.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving LDA as Assessed by Clinical Disease Activity Index (CDAI) at Months 3, 6, 9, 12, 15, 18, 21 and 24
CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<= 10 indicates LDA.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving LDA Based on Disease Activity Score (DAS28-4) Erythrocyte Sedimentation Rate (ESR) at Months 3, 6, 9, 12, 15, 18, 21 and 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\* square root of (TJC28) + 0.28\* square root of (SJC28) + 0.70\* natural log (ln) (ESR in \[millimeter per hour \[mm/ hour\]) + 0.014\*(PtGA in cm). PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR \<= 3.2 indicates LDA.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving LDA as Based on DAS28-4 C-Reactive Protein (CRP) at Months 3, 6, 9, 12, 15, 18, 21 and 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\* square root of (TJC28) + 0.28\* square root of (SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in mm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP \<= 3.2 indicates LDA.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by American College of Rheumatology (ACR)-EULAR Boolean Remission Criteria at Months 3, 6, 9, 12, 15, 18, 21 and 24
ACR-EULAR Boolean remission criteria was defined as when participant had ACR remission =1 if; TJC28 \<=1, SJC28 \<=1, CRP \<=1mg/dL and PtGA \<= 2 cm on a 0 to 10 cm scale, where higher values indicate greater affection due to disease activity.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by SDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24
SDAI was calculated using the following formula: SDAI = (TJC28) + (SJC28) + (PtGA in cm) + (PhGA in cm) + (CRP in mg/dL). TJC28 joints included shoulders, elbows, wrists, MCP and PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of \<=3.3 indicates remission.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by CDAI at Months 3, 6, 9, 12, 15, 18, 21 and 24
CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<=2.8 indicates remission.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by DAS-28 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.70\*In (ESR in mm/ hour) + 0.014\*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR score of \<2.6 indicates remission.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Remission as Assessed by DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP score of \<2.6 indicates remission.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in DAS28-4 ESR at Months 3, 6, 9, 12, 15, 18, 21 and 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.70\*In (ESR in mm/ hour) + 0.014\*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in DAS28-4 CRP at Months 3, 6, 9, 12, 15, 18, 21 and 24
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\*square root of(TJC28) + 0.28\*square root of(SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in Duration of Morning Stiffness at Months 3, 6, 9, 12, 15, 18, 21 and 24
The duration of morning stiffness was determined by asking the following questions: "When you wake up in the morning, do you currently suffer from morning stiffness?" "How long does the morning stiffness last from the time you wake up?". The change from baseline in duration of morning stiffness was calculated as: morning stiffness at time point -morning stiffness at baseline.
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in the Functional Ability Questionnaire Hannover (FFbH) at Months 3, 6, 9, 12, 15, 18, 21 and 24
The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points).The functional capacity (%) is calculated by (total score\*100) divided by (2\*number of valid responses). The change from baseline was calculated at each time point as functional capacity at timepoint - functional capacity at baseline.
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Number of Participants Achieving Functional Remission in FFbH at Months 3, 6, 9, 12, 15, 18, 21 and 24
The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points). The functional capacity \[%\] is calculated by (total score\*100)/ (2\*number of valid responses). Functional remission in FFbH was defined as functional capacity \> 83 %.
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in European Quality of Life (EuroQoL) Group EuroQoL- 5 Dimensions- 3 Levels (EQ-5D-3L) Total Scores at Months 3, 6, 9, 12, 15, 18, 21 and 24
The EQ-5D-3L is a standardised instrument used to measure quality of life. It is based on five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group (German weights) assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state.
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Scale at Months 3, 6, 9, 12, 15, 18, 21 and 24
The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).
Time frame: Baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24
Mean Number of Days of Drug Survival at Months 12 and 24
Drug survival was assessed using Kaplan-Meier methodology. For participants who terminated tofacitinib, the drug survival status was recorded as (status = 1 and time = termination date tofacitinib - date of initiation on tofacitinib) and for participants who do not terminate tofacitinib (status = 0 and time = date of final visit - date of initiation on tofacitinib.
Time frame: At 12 and 24 months
Number of Participants Per Categories of Satisfaction With Tofacitinib Treatment at Months 3, 6, 9, 12, 15, 18, 21 and 24
Satisfaction with treatment was assessed on a 5-point Likert scale (where 0 = extremely dissatisfied, 1= dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = extremely satisfied) in response to the question "How satisfied are you with the drugs that you have received for your arthritis since your last visit?".
Time frame: Months 3, 6, 9, 12, 15, 18, 21 and 24
Total 1518 participants were screened in this observational study, out of which 1459 eligible participants were enrolled and 59 we excluded. Out of these 59 participants, 30 participants were excluded due to retrospective screening failure and data review meeting decision as the type of therapy (monotherapy or combination therapy) was not defined and 29 participants were not eligible as their treatment with Tofacitinib was not started.
| Milestone | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Started | 779 | 440 | 111 | 129 |
| Completed | 521 | 304 | 90 | 105 |
| Not completed | 258 | 136 | 21 | 24 |
| Withdrew: Lost to follow-up | 16 | 12 | 1 | 0 |
| Withdrew: Other | 0 | 3 | 0 | 0 |
| Withdrew: Administrative reason | 166 | 89 | 17 | 19 |
| Withdrew: Revocation consent | 76 | 32 | 3 | 5 |
Treatment escalations was defined as participants who switched to another disease modifying antirheumatic drug (DMARD) or combination of DMARDs when compared to the last visit. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime towards e.g.a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, example (e.g.) from combination therapy to monotherapy. One participant can fall into more than 1 type of escalation.
| Participants | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Step-up/switch | 249 | 130 | 101 | 48 |
| Step-down | 29 | 51 | 39 | 91 |
| Treatment termination | 109 | 2 | 7 | 26 |
| Any escalation | 341 | 156 | 111 | 123 |
Time to treatment escalation was defined as time in days from escalation visit date to next escalation visit date. The following three types of escalations were reported: treatment termination, treatment step-up/switch and treatment step-down. Treatment termination was defined as the termination of a DMARD (or multiple when on combination therapy) without starting a new DMARD therapy. Treatment step-up/switch was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs and treatment step-down, was defined as de-escalation from the current treatment regime, e.g. from combination therapy to monotherapy. Number of participants with total number of each type of treatment escalations during the study (step-up/switch, step-down, treatment termination along with all escalations) are reported in this outcome measure.
| Days | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| All Escalations: 1 Treatment escalation | 288.21 ± 210.01 | 278.47 ± 188.96 | 221.95 ± 154.99 | 308.11 ± 190.70 |
| All Escalations: 2 Treatment escalation | 240.39 ± 162.67 | 219.47 ± 152.66 | 234.58 ± 154.80 | 239.20 ± 166.14 |
| All Escalations: 3 Treatment escalation | 175.56 ± 117.36 | 258.92 ± 153.07 | 216.84 ± 137.04 | 193.35 ± 126.70 |
| All Escalations: 4 Treatment escalation | 211.43 ± 133.53 | — | 202.88 ± 101.76 | 186.33 ± 60.67 |
| All Escalations: 5 Treatment escalation | 92.00 | — | 94.00 ± 4.36 | 160.00 |
| All Escalations: 6 Treatment escalation | — | — | — | 106.00 |
| Step up/switch: 1 Treatment escalation | 303.14 ± 214.45 | 286.58 ± 196.41 | 240.05 ± 169.23 | 273.15 ± 164.79 |
| Step up/switch: 2 Treatment escalation | 236.51 ± 170.99 | 242.07 ± 156.23 | 248.78 ± 169.24 | 258.74 ± 191.11 |
| Step up/switch: 3 Treatment escalation | 196.88 ± 129.53 | 194.71 ± 116.10 | 196.24 ± 109.94 | 188.33 ± 119.09 |
| Step up/switch: 4 Treatment escalation | 208.25 ± 172.07 | — | 185.40 ± 108.18 | 231.50 ± 129.40 |
| Step up/switch: 5 Treatment escalation | — | — | 95.50 ± 4.95 | — |
| Step down: 1 Treatment escalation | 304.55 ± 222.48 | 381.24 ± 212.79 | 392.46 ± 238.26 | 362.63 ± 201.10 |
| Step down: 2 Treatment escalation | — | 480.00 ± 5.66 | — | — |
| Treatment termination: 1 Treatment escalation | 336.52 ± 228.53 | 137.50 ± 64.35 | 520.80 ± 264.57 | 485.70 ± 246.06 |
Time to first step-up treatment escalation was defined for participants who experienced a treatment step-up and was measured as date of first treatment step up escalation minus (-) date of first prescription of tofacitinib. Treatment step-up was defined as an increase from the current treatment regime (monotherapy) towards a combination of DMARDs.
| Days | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Time to First Step Up Treatment Escalation | 611.33 ± 10.27 | 599.17 ± 12.38 | 268.07 ± 19.86 | 555.69 ± 21.68 |
SDAI was calculated using the following formula: SDAI = Tender Joint Count (TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 centimetre \[cm\] scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + C-reactive protein (CRP) (milligram per decilitre \[mg/dL\]). TJC28 joints included shoulders, elbows, wrists, metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm visual analogue scale (VAS) scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of less than or equal to (\<=11) indicates LDA.
| Participants | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Month 3 | 281 | 164 | 31 | 63 |
| Month 6 | 256 | 127 | 22 | 56 |
| Month 9 | 225 | 134 | 16 | 48 |
| Month 12 | 221 | 131 | 17 | 45 |
| Month 15 | 197 | 109 | 8 | 42 |
| Month 18 | 159 | 114 | 9 | 39 |
| Month 21 | 166 | 99 | 8 | 37 |
| Month 24 | 149 | 111 | 6 | 41 |
CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<= 10 indicates LDA.
| Participants | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Month 3 | 348 | 197 | 40 | 71 |
| Month 6 | 315 | 162 | 28 | 65 |
| Month 9 | 293 | 172 | 25 | 57 |
| Month 12 | 266 | 154 | 23 | 56 |
| Month 15 | 254 | 144 | 13 | 49 |
| Month 18 | 205 | 141 | 13 | 46 |
| Month 21 | 204 | 130 | 11 | 45 |
| Month 24 | 199 | 135 | 9 | 51 |
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\* square root of (TJC28) + 0.28\* square root of (SJC28) + 0.70\* natural log (ln) (ESR in \[millimeter per hour \[mm/ hour\]) + 0.014\*(PtGA in cm). PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR \<= 3.2 indicates LDA.
| Participants | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Month 3 | 253 | 155 | 32 | 57 |
| Month 6 | 224 | 131 | 21 | 49 |
| Month 9 | 204 | 116 | 15 | 42 |
| Month 12 | 200 | 131 | 16 | 39 |
| Month 15 | 157 | 108 | 12 | 37 |
| Month 18 | 161 | 107 | 11 | 32 |
| Month 21 | 147 | 103 | 7 | 32 |
| Month 24 | 138 | 101 | 8 | 32 |
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\* square root of (TJC28) + 0.28\* square root of (SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in mm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP \<= 3.2 indicates LDA.
| Participants | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Month 3 | 308 | 175 | 38 | 65 |
| Month 6 | 280 | 136 | 24 | 60 |
| Month 9 | 250 | 144 | 19 | 54 |
| Month 12 | 234 | 137 | 17 | 47 |
| Month 15 | 202 | 115 | 10 | 42 |
| Month 18 | 172 | 117 | 10 | 42 |
| Month 21 | 174 | 110 | 8 | 38 |
| Month 24 | 156 | 117 | 6 | 41 |
ACR-EULAR Boolean remission criteria was defined as when participant had ACR remission =1 if; TJC28 \<=1, SJC28 \<=1, CRP \<=1mg/dL and PtGA \<= 2 cm on a 0 to 10 cm scale, where higher values indicate greater affection due to disease activity.
| Participants | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Month 3 | 21 | 15 | 1 | 8 |
| Month 6 | 22 | 13 | 0 | 6 |
| Month 9 | 25 | 9 | 1 | 0 |
| Month 12 | 28 | 12 | 1 | 2 |
| Month 15 | 11 | 5 | 1 | 4 |
| Month 18 | 11 | 11 | 0 | 2 |
| Month 21 | 13 | 12 | 1 | 2 |
| Month 24 | 11 | 7 | 0 | 4 |
SDAI was calculated using the following formula: SDAI = (TJC28) + (SJC28) + (PtGA in cm) + (PhGA in cm) + (CRP in mg/dL). TJC28 joints included shoulders, elbows, wrists, MCP and PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of \<=3.3 indicates remission.
| Participants | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Month 3 | 72 | 47 | 4 | 21 |
| Month 6 | 71 | 40 | 2 | 22 |
| Month 9 | 73 | 43 | 2 | 15 |
| Month 12 | 78 | 40 | 4 | 16 |
| Month 15 | 48 | 34 | 3 | 15 |
| Month 18 | 48 | 39 | 2 | 15 |
| Month 21 | 51 | 34 | 4 | 17 |
| Month 24 | 46 | 38 | 2 | 21 |
CDAI was calculated using the following formula: CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm). TJC28 joints included shoulders, elbows, wrists, MCP and proximal PIP joints, and knees whereas SJC28 included shoulders, elbows, wrists, MCP, PIP and knees (excluding artificial joints). PtGA and PhGA both were assessed on 0-10 cm VAS scale (0 cm \[very well\] to 10 cm \[worst\], where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of \<=2.8 indicates remission.
| Participants | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Month 3 | 94 | 65 | 8 | 28 |
| Month 6 | 96 | 61 | 5 | 27 |
| Month 9 | 84 | 59 | 5 | 19 |
| Month 12 | 98 | 51 | 6 | 18 |
| Month 15 | 67 | 55 | 6 | 17 |
| Month 18 | 68 | 51 | 4 | 20 |
| Month 21 | 68 | 49 | 8 | 23 |
| Month 24 | 69 | 53 | 3 | 26 |
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.70\*In (ESR in mm/ hour) + 0.014\*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 ESR score of \<2.6 indicates remission.
| Participants | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Month 3 | 162 | 101 | 17 | 45 |
| Month 6 | 143 | 97 | 9 | 32 |
| Month 9 | 139 | 80 | 9 | 27 |
| Month 12 | 136 | 90 | 6 | 22 |
| Month 15 | 100 | 76 | 5 | 25 |
| Month 18 | 102 | 76 | 8 | 23 |
| Month 21 | 92 | 65 | 6 | 22 |
| Month 24 | 80 | 68 | 5 | 26 |
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 CRP score of \<2.6 indicates remission.
| Participants | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Month 3 | 238 | 125 | 27 | 55 |
| Month 6 | 208 | 104 | 19 | 52 |
| Month 9 | 199 | 103 | 14 | 41 |
| Month 12 | 196 | 110 | 13 | 38 |
| Month 15 | 151 | 88 | 6 | 35 |
| Month 18 | 137 | 90 | 8 | 34 |
| Month 21 | 133 | 83 | 5 | 33 |
| Month 24 | 122 | 88 | 4 | 37 |
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated using the following formula: 0.56\*square root of (TJC28) + 0.28\*square root of (SJC28) + 0.70\*In (ESR in mm/ hour) + 0.014\*PtGA in cm. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.
| Units on a scale | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Change at Month 3 | -1.47 ± 1.49 | -1.36 ± 1.34 | -1.03 ± 1.77 | -1.69 ± 1.48 |
| Change at Month 6 | -1.52 ± 1.48 | -1.49 ± 1.41 | -0.81 ± 1.58 | -1.80 ± 1.39 |
| Change at Month 9 | -1.67 ± 1.61 | -1.56 ± 1.37 | -1.23 ± 1.66 | -1.50 ± 1.51 |
| Change at Month 12 | -1.74 ± 1.64 | -1.76 ± 1.41 | -1.81 ± 1.38 | -1.57 ± 1.49 |
| Change at Month 15 | -1.69 ± 1.54 | -1.84 ± 1.45 | -2.15 ± 0.74 | -1.70 ± 1.53 |
| Change at Month 18 | -1.63 ± 1.55 | -1.84 ± 1.44 | -2.15 ± 0.93 | -1.68 ± 1.47 |
| Change at Month 21 | -1.62 ± 1.59 | -1.72 ± 1.54 | -1.81 ± 1.32 | -1.87 ± 1.60 |
| Change at Month 24 | -1.65 ± 1.63 | -1.77 ± 1.47 | -1.85 ± 0.90 | -1.87 ± 1.51 |
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated using the following formula: 0.56\*square root of(TJC28) + 0.28\*square root of(SJC28) + 0.36\*ln (CRP in mg/l +1) + 0.014\*(PtGA in cm)+ 0.96. PtGA was assessed on 0-10 cm VAS scale (scores ranging from 0 cm \[very well\] to 10 cm \[worst\]), where higher scores indicated greater affliction due to disease activity). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.
| Units on a scale | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Change at Month 3 | -1.55 ± 1.40 | -1.40 ± 1.28 | -1.04 ± 1.42 | -1.63 ± 1.35 |
| Change at Month 6 | -1.72 ± 1.43 | -1.52 ± 1.36 | -0.94 ± 1.38 | -1.90 ± 1.26 |
| Change at Month 9 | -1.82 ± 1.50 | -1.64 ± 1.22 | -1.15 ± 1.45 | -1.66 ± 1.36 |
| Change at Month 12 | -1.90 ± 1.53 | -1.79 ± 1.35 | -1.86 ± 1.32 | -1.68 ± 1.28 |
| Change at Month 15 | -1.89 ± 1.44 | -1.77 ± 1.26 | -2.13 ± 1.49 | -1.75 ± 1.39 |
| Change at Month 18 | -1.84 ± 1.49 | -1.85 ± 1.37 | -2.06 ± 1.51 | -1.62 ± 1.34 |
| Change at Month 21 | -1.81 ± 1.49 | -1.74 ± 1.47 | -1.67 ± 1.27 | -1.84 ± 1.45 |
| Change at Month 24 | -1.84 ± 1.49 | -1.79 ± 1.40 | -1.48 ± 1.04 | -1.92 ± 1.31 |
The duration of morning stiffness was determined by asking the following questions: "When you wake up in the morning, do you currently suffer from morning stiffness?" "How long does the morning stiffness last from the time you wake up?". The change from baseline in duration of morning stiffness was calculated as: morning stiffness at time point -morning stiffness at baseline.
| Minutes | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Change at Month 3 | -27.71 ± 86.53 | -22.23 ± 108.98 | -44.73 ± 164.97 | -26.48 ± 45.41 |
| Change at Month 6 | -29.00 ± 110.51 | -25.74 ± 126.36 | -35.18 ± 60.26 | -28.64 ± 48.50 |
| Change at Month 9 | -37.00 ± 97.53 | -36.16 ± 113.11 | -38.43 ± 70.31 | -29.55 ± 62.24 |
| Change at Month 12 | -42.11 ± 100.95 | -35.88 ± 105.09 | -27.18 ± 45.05 | -32.59 ± 57.80 |
| Change at Month 15 | -37.20 ± 123.17 | -42.20 ± 118.62 | -36.20 ± 44.26 | -35.12 ± 61.01 |
| Change at Month 18 | -41.01 ± 106.86 | -36.57 ± 107.59 | -47.95 ± 63.25 | -34.95 ± 58.77 |
| Change at Month 21 | -31.24 ± 137.43 | -28.71 ± 50.98 | -42.47 ± 58.09 | -31.13 ± 65.98 |
| Change at Month 24 | -33.12 ± 61.16 | -38.17 ± 116.88 | -26.36 ± 65.33 | -39.88 ± 61.46 |
The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points).The functional capacity (%) is calculated by (total score\*100) divided by (2\*number of valid responses). The change from baseline was calculated at each time point as functional capacity at timepoint - functional capacity at baseline.
| Percent functional capacity | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Change at Month 3 | 6.73 ± 15.08 | 5.31 ± 16.05 | 8.82 ± 15.75 | 6.52 ± 14.29 |
| Change at Month 6 | 8.73 ± 17.14 | 6.12 ± 17.23 | 10.82 ± 18.57 | 7.02 ± 15.08 |
| Change at Month 9 | 8.49 ± 16.60 | 6.45 ± 15.83 | 12.23 ± 17.22 | 5.33 ± 15.40 |
| Change at Month 12 | 8.41 ± 16.69 | 7.78 ± 17.22 | 13.59 ± 19.05 | 7.26 ± 14.58 |
| Change at Month 15 | 8.42 ± 17.64 | 8.56 ± 17.33 | 13.83 ± 19.05 | 6.55 ± 14.96 |
| Change at Month 18 | 8.20 ± 17.75 | 8.15 ± 17.42 | 17.90 ± 18.26 | 5.90 ± 14.65 |
| Change at Month 21 | 9.46 ± 19.24 | 7.43 ± 17.42 | 16.00 ± 17.36 | 4.23 ± 13.27 |
| Change at Month 24 | 9.38 ± 18.50 | 8.78 ± 17.61 | 15.21 ± 20.50 | 7.18 ± 16.00 |
The FFbH for RA is a German short questionnaire for the assessment of patientive functional capacity in the context of basic everyday activities (range: 0-100% functional capacity, where higher percentage indicates more capacity for everyday activities). The FFbH questionnaire consisted of 18 questions with 3 possible responses (Yes; Yes, but with effort; No or only with outside help). The total score was the sum of the scores of all 18 questions, where for each question (Yes = 2 points; Yes, but with effort = 1 point; No or only with outside help = 0 points). The functional capacity \[%\] is calculated by (total score\*100)/ (2\*number of valid responses). Functional remission in FFbH was defined as functional capacity \> 83 %.
| Participants | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Month 3 | 174 | 114 | 18 | 47 |
| Month 6 | 157 | 102 | 17 | 40 |
| Month 9 | 139 | 84 | 14 | 34 |
| Month 12 | 116 | 85 | 9 | 31 |
| Month 15 | 122 | 84 | 6 | 25 |
| Month 18 | 99 | 80 | 7 | 26 |
| Month 21 | 99 | 65 | 7 | 19 |
| Month 24 | 92 | 62 | 8 | 26 |
The EQ-5D-3L is a standardised instrument used to measure quality of life. It is based on five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group (German weights) assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state.
| Units on a scale | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Change at Month 3 | 0.119 ± 0.205 | 0.109 ± 0.195 | 0.079 ± 0.197 | 0.102 ± 0.159 |
| Change at Month 6 | 0.134 ± 0.214 | 0.110 ± 0.217 | 0.090 ± 1.197 | 0.100 ± 0.192 |
| Change at Month 9 | 0.133 ± 0.204 | 0.118 ± 0.222 | 0.120 ± 0.188 | 0.054 ± 0.206 |
| Change at Month 12 | 0.142 ± 0.210 | 0.122 ± 0.221 | 0.087 ± 0.228 | 0.095 ± 0.173 |
| Change at Month 15 | 0.137 ± 0.223 | 0.135 ± 0.207 | 0.149 ± 0.199 | 0.102 ± 0.259 |
| Change at Month 18 | 0.140 ± 0.206 | 0.127 ± 0.209 | 0.169 ± 0.237 | 0.098 ± 0.196 |
| Change at Month 21 | 0.134 ± 0.207 | 0.122 ± 0.210 | 0.151 ± 0.202 | 0.106 ± 0.206 |
| Change at Month 24 | 0.133 ± 0.207 | 0.137 ± 0.205 | 0.163 ± 0.199 | 0.125 ± 0.226 |
The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).
| Units on a scale | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Change at Month 3 | 4.83 ± 9.63 | 3.59 ± 8.57 | 3.71 ± 9.99 | 3.35 ± 9.12 |
| Change at Month 6 | 5.57 ± 10.11 | 4.25 ± 10.11 | 5.68 ± 8.79 | 2.58 ± 9.28 |
| Change at Month 9 | 5.63 ± 9.87 | 4.44 ± 9.46 | 5.34 ± 10.93 | 1.78 ± 10.53 |
| Change at Month 12 | 5.78 ± 10.69 | 5.54 ± 9.88 | 6.61 ± 10.73 | 4.24 ± 10.49 |
| Change at Month 15 | 5.63 ± 10.57 | 5.34 ± 9.94 | 6.33 ± 12.14 | 3.31 ± 10.05 |
| Change at Month 18 | 5.96 ± 10.51 | 5.91 ± 9.92 | 13.05 ± 8.93 | 3.44 ± 8.04 |
| Change at Month 21 | 6.32 ± 11.17 | 6.65 ± 9.85 | 11.43 ± 10.62 | 4.02 ± 9.87 |
| Change at Month 24 | 6.03 ± 10.36 | 6.72 ± 9.31 | 12.69 ± 8.40 | 4.49 ± 9.68 |
Drug survival was assessed using Kaplan-Meier methodology. For participants who terminated tofacitinib, the drug survival status was recorded as (status = 1 and time = termination date tofacitinib - date of initiation on tofacitinib) and for participants who do not terminate tofacitinib (status = 0 and time = date of final visit - date of initiation on tofacitinib.
| Days | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Month 12 | 339.83 ± 5.73 | 341.17 ± 7.18 | 233.30 ± 14.00 | 337.36 ± 12.48 |
| Month 24 | 534.49 ± 11.35 | 542.15 ± 14.28 | 317.51 ± 25.09 | 532.39 ± 25.94 |
Satisfaction with treatment was assessed on a 5-point Likert scale (where 0 = extremely dissatisfied, 1= dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = extremely satisfied) in response to the question "How satisfied are you with the drugs that you have received for your arthritis since your last visit?".
| Participants | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Month 3 — Extremely dissatisfied | 43 | 19 | 5 | 11 |
| Month 3 — Dissatisfied | 41 | 26 | 15 | 5 |
| Month 3 — Neither satisfied nor dissatisfied | 107 | 63 | 22 | 20 |
| Month 3 — Satisfied | 290 | 166 | 32 | 43 |
| Month 3 — Extremely satisfied | 98 | 57 | 9 | 23 |
| Month 6 — Extremely dissatisfied | 39 | 13 | 2 | 11 |
| Month 6 — Dissatisfied | 22 | 13 | 9 | 5 |
| Month 6 — Neither satisfied nor dissatisfied | 78 | 51 | 13 | 10 |
| Month 6 — Satisfied | 242 | 137 | 32 | 41 |
| Month 6 — Extremely satisfied | 107 | 69 | 5 | 22 |
| Month 9 — Extremely dissatisfied | 27 | 11 | 0 | 4 |
| Month 9 — Dissatisfied | 15 | 9 | 7 | 7 |
| Month 9 — Neither satisfied nor dissatisfied | 54 | 23 | 7 | 10 |
| Month 9 — Satisfied | 218 | 137 | 26 | 36 |
| Month 9 — Extremely satisfied | 108 | 60 | 8 | 23 |
| Month 12 — Extremely dissatisfied | 17 | 21 | 4 | 5 |
| Month 12 — Dissatisfied | 14 | 5 | 0 | 1 |
| Month 12 — Neither satisfied nor dissatisfied | 38 | 21 | 7 | 11 |
| Month 12 — Satisfied | 207 | 117 | 19 | 38 |
| Month 12 — Extremely satisfied | 94 | 51 | 4 | 17 |
| Month 15 — Extremely dissatisfied | 16 | 10 | 0 | 4 |
| Month 15 — Dissatisfied | 15 | 6 | 1 | 0 |
| Month 15 — Neither satisfied nor dissatisfied | 37 | 24 | 5 | 8 |
| Month 15 — Satisfied | 170 | 105 | 13 | 26 |
| Month 15 — Extremely satisfied | 98 | 52 | 6 | 22 |
| Month 18 — Extremely dissatisfied | 14 | 11 | 0 | 2 |
| Month 18 — Dissatisfied | 12 | 5 | 1 | 2 |
| Month 18 — Neither satisfied nor dissatisfied | 32 | 17 | 0 | 7 |
| Month 18 — Satisfied | 156 | 107 | 12 | 29 |
| Month 18 — Extremely satisfied | 94 | 54 | 7 | 23 |
| Month 21 — Extremely dissatisfied | 12 | 9 | 0 | 4 |
| Month 21 — Dissatisfied | 11 | 4 | 1 | 1 |
| Month 21 — Neither satisfied nor dissatisfied | 20 | 15 | 0 | 2 |
| Month 21 — Satisfied | 137 | 88 | 9 | 29 |
| Month 21 — Extremely satisfied | 97 | 47 | 5 | 17 |
| Month 24 — Extremely dissatisfied | 17 | 13 | 2 | 6 |
| Month 24 — Dissatisfied | 5 | 2 | 1 | 0 |
| Month 24 — Neither satisfied nor dissatisfied | 19 | 16 | 3 | 3 |
| Month 24 — Satisfied | 135 | 73 | 5 | 26 |
| Month 24 — Extremely satisfied | 81 | 54 | 3 | 22 |
Collected over From date of first prescription of tofacitinib up to 24 months (maximum up to 24 Months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tofacitinib Monotherapy | 6/779 (0.8%) | 141/779 (18.1%) | 402/779 (51.6%) |
| Tofacitinib+Methotrexate (MTX) Combination Therapy | 5/440 (1.1%) | 69/440 (15.7%) | 240/440 (54.5%) |
| Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | 0/111 (0%) | 24/111 (21.6%) | 81/111 (73%) |
| Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | 0/129 (0%) | 27/129 (20.9%) | 84/129 (65.1%) |
| Event | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Drug ineffectiveGeneral disorders | 13/779 | 9/440 | 6/111 | 3/129 |
| Therapeutic product effect decreasedGeneral disorders | 5/779 | 1/440 | 3/111 | 0/129 |
| Therapeutic product effect incompleteGeneral disorders | 7/779 | 3/440 | 2/111 | 3/129 |
| COVID-19 pneumoniaInfections and infestations | 1/779 | 1/440 | 2/111 | 0/129 |
| Drug intoleranceGeneral disorders | 2/779 | 2/440 | 0/111 | 2/129 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 10/779 | 4/440 | 0/111 | 1/129 |
| Hypertensive crisisVascular disorders | 8/779 | 1/440 | 1/111 | 1/129 |
| FallInjury, poisoning and procedural complications | 2/779 | 4/440 | 0/111 | 1/129 |
| Herpes zosterInfections and infestations | 2/779 | 3/440 | 1/111 | 1/129 |
| Bursitis infectiveInfections and infestations | 0/779 | 0/440 | 1/111 | 1/129 |
| Event | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy |
|---|---|---|---|---|
| Therapeutic product effect incompleteGeneral disorders | 21/779 | 15/440 | 14/111 | 5/129 |
| Drug ineffectiveGeneral disorders | 69/779 | 42/440 | 11/111 | 15/129 |
| Therapeutic product effect decreasedGeneral disorders | 36/779 | 21/440 | 12/111 | 9/129 |
| NauseaGastrointestinal disorders | 19/779 | 12/440 | 6/111 | 10/129 |
| Influenza like illnessGeneral disorders | 26/779 | 21/440 | 7/111 | 3/129 |
| HeadacheNervous system disorders | 24/779 | 7/440 | 6/111 | 2/129 |
| Herpes zosterInfections and infestations | 18/779 | 8/440 | 2/111 | 5/129 |
| NasopharyngitisInfections and infestations | 10/779 | 17/440 | 3/111 | 4/129 |
| DizzinessNervous system disorders | 12/779 | 16/440 | 4/111 | 1/129 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 11/779 | 10/440 | 4/111 | 4/129 |
Baseline analysis population included all enrolled participants.
| Age, Customized(Participants) | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Total |
|---|---|---|---|---|---|
| 18-44 years | 90 | 43 | 13 | 22 | 168 |
| 45-64 years | 389 | 287 | 75 | 61 | 812 |
| More than or equal to (>=) 65 years | 300 | 110 | 23 | 46 | 479 |
| Sex: Female, Male(Participants) | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Total |
|---|---|---|---|---|---|
| Female | 627 | 307 | 90 | 91 | 1115 |
| Male | 152 | 133 | 21 | 38 | 344 |
| Race and Ethnicity Not Collected(Participants) | Tofacitinib Monotherapy | Tofacitinib+Methotrexate (MTX) Combination Therapy | Tofacitinib Monotherapy To Tofacitinib+ MTX Combination Therapy | Tofacitinib+ MTX Combination Therapy to Tofacitinib Monotherapy | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Ran from Nov 2017 to primary completion in Jul 2023, 68 months.
Results were first posted in Oct 2024, 1 year 3 months after primary completion.
Of 155 industry-sponsored observational studies under Arthritis, Rheumatoid, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 116. This study's 68 months is above that.
Counting every sponsor, half of 391 studies reached it within 50 months; a quarter within 25 and three quarters within 113.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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