CompletedNCT01255761PREDICTUpdated Jul 31, 2018Results posted

A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects

A Phase 4 interventional study of Certolizumab Pegol (CZP) in Rheumatoid Arthritis, sponsored by UCB Pharma. Completed at 110 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-31.

Sponsored by UCB Pharma · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 736
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Phase 4 study to evaluate a routine patient completed assessment (RAPID3) compared to a physician completed assessment (CDAI) to predict treatment success with subjects with moderate to severe rheumatoid arthritis

Read the detailed description

RA0064 is a Phase 4, multicenter, randomized, 52-week study. All eligible subjects will receive open label Cimzia 400 mg at Weeks 0, 2 and 4, followed by Cimzia 200 mg every 2 weeks at Weeks 6 to 50 for the treatment of moderate to severe rheumatoid arthritis. All subjects will be assessed using the 2 assessment tools: the subject-based Routine Assessment of Patient Index (RAPID3) and the investigator-based Clinical Disease Activity Index (CDAI)

Conditions studied

Rheumatoid Arthritis

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Keywords

Certolizumab Pegol
Cimzia
Rheumatoid Arthritis
CDAI
RAPID3

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 736 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

UCB Pharma is the lead sponsor of 238 studies on the registry; none are open to participants now.

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

Who can participate

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

Inclusion criteria

Subjects 18 years of age or older
Subjects with a diagnosis of Adult-onset Rheumatoid Arthritis of at least 3 months as defined by the 1987 American College of Rheumatology (ACR) classification criteria
Subjects with active Rheumatoid Arthritis as defined by:
- 4 tender joints (28 joint count) at Screening and Baseline Visits; and
- 4 swollen joints (28 joint count) at Screening and Baseline Visits
Subjects who have had an unsatisfactory response or intolerance to at least 1 traditional Disease-modifying Antirheumatic Drugs (DMARD)

Exclusion criteria

Exclusion Criteria:

Subjects must not have a diagnosis of any other inflammatory Arthritis
Subjects must not have greater than 3 Arthroplasties due to Rheumatoid Arthritis and/or Steinbrocker IV Functional Capacity
Subjects must not have a secondary non-inflammatory type of Arthritis that would interfere with study evaluation
Subjects must not be diagnosed with Fibromyalgia with sufficient symptoms requiring treatment
Subjects must not have a history of Infected Joint Prosthesis
Subjects must not have discontinued biological therapy for their Rheumatoid Arthritis due to Severe Hypersensitivity Reaction or Anaphylactic Reaction
Subjects must not have received more than 2 anti- Tumor Necrosis Factor (TNF) agents prior to enrollment
Subjects must not have received treatment with Abatacept and/or Rituximab or have received any experimental or approved B cell therapeutic agent
Subjects must not have a history of chronic alcohol or drug abuse
Subjects must not have known hypersensitivity to any components of the investigational medicinal product
Subjects must not have a history of chronic infections, recent serious or life-threatening infection within 6 months or any current sign or symptom that may indicate an infection
Subjects must not have a history of a Blood Dyscrasias
Subjects with known Tuberculosis (TB) Disease, high risk of acquiring TB or latent TB infection
Subjects must not be at high risk of infection
Subjects must not have a history of Lymphoproliferative Disorder including Lymphoma signs and symptoms suggestive of Lymphoproliferative Disease
Subjects must not have concurrent acute or chronic Viral Hepatitis B or C
Subjects must not have known Human Immunodeficiency Virus (HIV) infection
Subject must not have concurrent Malignancy or history of Malignancy
Subjects must not have a current or recent history of severe, progressive, and/or uncontrolled Renal, Hepatic, Hematological, Gastrointestinal, Endocrine, Pulmonary, Cardiac, Neurological or Cerebral Disease
Subjects must not have Class III or IV Congestive Heart Failure
Subjects must not have history of, or suspected Demyelinating Disease of the Central Nervous System
Subjects must not have a history of adverse reaction to Polyethylene Glycol (PEG)
Subjects must not have significant laboratory abnormalities which in the investigators judgment would make the subject unsuitable for inclusion
Subjects must not have a known history or clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, Nontuberculous Mycobacteria, Blastomyces or Aspergillus
Subject must not have a known history of or be currently diagnosed with Systemic Lupus Erythematosus

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 736 participants (actual)

Study arms

Other
RAPID3 to assess response to Cimzia
RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points
Biological: Certolizumab Pegol (CZP)
Other
CDAI to assess response to Cimzia
CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia. Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)
Biological: Certolizumab Pegol (CZP)

Interventions

BiologicalCertolizumab Pegol (CZP)
400 mg subcutaneous injection at Weeks 0, 2 and 4 200 mg subcutaneous injection every two weeks, Week 6 through Week 52
Also known as: Cimzia

What researchers measure

Primary outcomes

Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]
For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. CDAI is the sum of tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - VAS (VAS in cm). 28 joints are examined. RAPID3 is the sum of the MDHAQ subscores of physical function, pain, and patient's global status.
Time frame: Baseline (Week 0) to Week 12
Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52
For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.
Time frame: Baseline (Week 0) to Week 52

Secondary outcomes

Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52
For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.
Time frame: Baseline (Week 0) to Week 52
Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52
For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.
Time frame: Baseline (Week 0) to Week 52
Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52
For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.
Time frame: Baseline (Week 0) to Week 52
Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12
The DAS28(ESR) score is a measure of the subject's disease activity. DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.
Time frame: Baseline (Week 0) to Week 12
Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52
The DAS28(ESR) score is a measure of the subject's disease activity. DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.
Time frame: Baseline (Week 0) to Week 52
Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time frame: Baseline (Week 0) to Week 12
Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time frame: Baseline (Week 0) to Week 52
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time frame: Baseline (Week 0) to Week 12
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time frame: Baseline (Week 0) to Week 52
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.
Time frame: Week 12
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.
Time frame: Week 52
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.
Time frame: Week 12
Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52
DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.
Time frame: Week 52
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time frame: Week 12
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time frame: Week 52
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time frame: Week 12
Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52
CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time frame: Week 52
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time frame: Week 12
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time frame: Week 52
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time frame: Week 12
Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52
RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.
Time frame: Week 52
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Number of work days missed in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 12
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Number of work days with reduced productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 12
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 12
Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Number of days with no household work in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 12
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Number of days with reduced household work productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 12
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Number of days missed of family/social/leisure activities in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 12
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Number of days with hired outside help in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 12
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 12
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Number of work days missed in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 52
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Number of work days with reduced productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 52
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 52
Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Number of days with no household work in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 52
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Number of days with reduced household work productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 52
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Number of days missed of family/social/leisure activities in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 52
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Number of days with hired outside help in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 52
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.
Time frame: Week 52

Results

Posted Mar 7, 2014

Participant flow

Enrollment began in November 2010. Overall study completion occurred in December 2012. The Participant Flow consists of the Randomized Set (RS). The RS consists of all subjects randomized into the study. The Baseline Characteristics consists of the Safety Set (SS). SS consists of all subjects that received at least 1 dose of study medication.

Participant flow — Overall Study
Milestone	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Started	369	367
Completed	187	192
Not completed	182	175
Withdrew: Adverse event	29	43
Withdrew: Lack of efficacy	86	74
Withdrew: Protocol violation	9	5
Withdrew: Lost to follow-up	10	8
Withdrew: Withdrawal by subject	11	27
Withdrew: Other reasons	37	18

Outcome measures

PrimaryResponse at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]

For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. CDAI is the sum of tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - VAS (VAS in cm). 28 joints are examined. RAPID3 is the sum of the MDHAQ subscores of physical function, pain, and patient's global status.

Time frame:: Baseline (Week 0) to Week 12
Reported as:: Number · percentage of participants

Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)]
percentage of participants	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	64.7	76.4
No	35.3	23.6

Statistical analysis

RAPID3 to Assess Response to Cimzia vs CDAI to Assess Response to Cimzia · ANCOVA · Difference in proportion: -0.119 · 95% CI -0.184 to -0.053Difference in proportions from ANCOVA with tool as factor \& Baseline DAS28(ESR), gender, age, prior anti-TNF use \& disease duration as covariates.

PrimaryResponders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52

For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.

Time frame:: Baseline (Week 0) to Week 52
Reported as:: Number · percentage of participants

Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52
percentage of participants	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	31.5	32.3
No	68.5	67.7

Statistical analysis

RAPID3 to Assess Response to Cimzia vs CDAI to Assess Response to Cimzia · ANCOVA · Difference in proportion: -0.013 · 95% CI -0.093 to 0.066Difference in proportions from ANCOVA with tool as factor \& Baseline DAS28(ESR), gender, age, prior anti-TNF use \& disease duration as covariates.

SecondaryPercentage of All Subjects Who Are Both Responders at Week 12 and With Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52

For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.

Time frame:: Baseline (Week 0) to Week 52
Reported as:: Number · percentage of participants

Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52
percentage of participants	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	44.3	51.8
No	55.7	48.2

SecondaryResponders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52

For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.

Time frame:: Baseline (Week 0) to Week 52
Reported as:: Number · percentage of participants

Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52
percentage of participants	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	21.8	23.3
No	78.2	76.7

SecondaryPercentage of All Subjects Who Are Both Responders at Week 12 and With Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52

For subjects randomized to CDAI, response is defined as CDAI ≤10 or 20% improvement from Baseline. For subjects randomized to RAPID3, response is defined as RAPID3 ≤6 or 20% improvement from Baseline. DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat (ESR) + 0.014xGlobal Assessment of Arthritis where 28 joints are examined.

Time frame:: Baseline (Week 0) to Week 52
Reported as:: Number · percentage of participants

Percentage of All Subjects Who Are Both Responders at Week 12 and With Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52
percentage of participants	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	50.5	58.6
No	49.5	41.4

SecondaryChange From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12

The DAS28(ESR) score is a measure of the subject's disease activity. DAS28(ESR) is calculated from the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.

Time frame:: Baseline (Week 0) to Week 12
Reported as:: Mean · units on a scale

Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12
units on a scale	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Change From Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 12	-2.20 ± 1.33	-2.11 ± 1.39

SecondaryChange From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52

Time frame:: Baseline (Week 0) to Week 52
Reported as:: Mean · units on a scale

Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52
units on a scale	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Change From Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] Assessed at Week 52	-2.26 ± 1.45	-2.14 ± 1.50

SecondaryChange From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12

CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, and Investigator's Global Assessment of Disease Activity - Visual Analog Scale (VAS in cm). 28 joints are examined. The range for the CDAI is 0 - 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.

Time frame:: Baseline (Week 0) to Week 12
Reported as:: Mean · units on a scale

Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12
units on a scale	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12	-23.79 ± 14.35	-23.11 ± 14.57

SecondaryChange From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52

Time frame:: Baseline (Week 0) to Week 52
Reported as:: Mean · units on a scale

Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52
units on a scale	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52	-24.55 ± 15.42	-23.16 ± 15.20

SecondaryChange From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12

RAPID3 is the sum of the Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscores of physical function, pain, and patient's global status. The range for the RAPID3 is 0 - 30 with a negative change in RAPID3 score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.

Time frame:: Baseline (Week 0) to Week 12
Reported as:: Mean · units on a scale

Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12
units on a scale	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12	-6.78 ± 5.94	-6.47 ± 6.69

SecondaryChange From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52

Time frame:: Baseline (Week 0) to Week 52
Reported as:: Mean · units on a scale

Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52
units on a scale	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52	-6.36 ± 6.48	-6.65 ± 6.99

SecondaryPercentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12

DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore, using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.

Time frame:: Week 12
Reported as:: Number · percentage of subjects

Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12
percentage of subjects	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	25.0	28.2
No	75.0	71.8

SecondaryPercentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52

Time frame:: Week 52
Reported as:: Number · percentage of subjects

Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 52
percentage of subjects	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	21.5	24.9
No	78.5	75.1

SecondaryPercentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12

DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.

Time frame:: Week 12
Reported as:: Number · percentage of subjects

Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12
percentage of subjects	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	12.8	15.6
No	87.2	84.4

SecondaryPercentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52

DAS28(ESR) is calculated from the tender joint count, swollen joint count, erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity as assessed by Multi-dimensional Health Assessment Questionnaire (MDHAQ) subscore using this formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined. Lower scores indicate less disease activity.

Time frame:: Week 52
Reported as:: Number · percentage of subjects

Percentage of Subjects With DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52
percentage of subjects	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	14.9	17.8
No	85.1	82.2

SecondaryPercentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12

Time frame:: Week 12
Reported as:: Number · percentage of subjects

Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12
percentage of subjects	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	34.8	38.1
No	65.2	61.9

SecondaryPercentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52

Time frame:: Week 52
Reported as:: Number · percentage of subjects

Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52
percentage of subjects	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	30.2	33.4
No	69.8	66.6

SecondaryPercentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12

Time frame:: Week 12
Reported as:: Number · percentage of subjects

Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12
percentage of subjects	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	10.1	10.1
No	89.9	89.9

SecondaryPercentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52

Time frame:: Week 52
Reported as:: Number · percentage of subjects

Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52
percentage of subjects	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	12.2	15.6
No	87.8	84.4

SecondaryPercentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12

Time frame:: Week 12
Reported as:: Number · percentage of subjects

Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12
percentage of subjects	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	33.7	33.4
No	66.3	66.6

SecondaryPercentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52

Time frame:: Week 52
Reported as:: Number · percentage of subjects

Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52
percentage of subjects	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	27.7	28.8
No	72.3	71.2

SecondaryPercentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12

Time frame:: Week 12
Reported as:: Number · percentage of subjects

Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12
percentage of subjects	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	14.9	18.9
No	85.1	81.1

SecondaryPercentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52

Time frame:: Week 52
Reported as:: Number · percentage of subjects

Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52
percentage of subjects	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Yes	18.8	20.8
No	81.3	79.2

SecondaryNumber of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12

Number of work days missed in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 12
Reported as:: Mean · Number of work days missed in last month

Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Number of work days missed in last month	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	0.7 ± 3.6	0.7 ± 3.1

SecondaryNumber of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12

Number of work days with reduced productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 12
Reported as:: Mean · Work days with reduced work productivity

Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Work days with reduced work productivity	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	1.1 ± 3.5	1.2 ± 3.5

SecondaryInterference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12

The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 12
Reported as:: Mean · units on a scale

Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
units on a scale	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	1.7 ± 2.3	1.6 ± 2.5

SecondaryNumber of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12

Number of days with no household work in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 12
Reported as:: Mean · Days with no household work

Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Days with no household work	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	3.2 ± 5.9	3.1 ± 5.8

SecondaryNumber of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12

Number of days with reduced household work productivity in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 12
Reported as:: Mean · Days with reduced household work

Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Days with reduced household work	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	3.1 ± 5.7	3.1 ± 5.6

SecondaryNumber of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12

Number of days missed of family/social/leisure activities in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 12
Reported as:: Mean · Activity days missed

Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Activity days missed	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	0.7 ± 2.4	0.9 ± 3.5

SecondaryNumber of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12

Number of days with hired outside help in the last month The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 12
Reported as:: Mean · Days with hired outside help

Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
Days with hired outside help	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	0.4 ± 2.2	0.5 ± 2.5

SecondaryInterference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12

The arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 12
Reported as:: Mean · units on a scale

Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12
units on a scale	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12	2.7 ± 2.7	2.4 ± 2.8

SecondaryNumber of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52

Number of work days missed in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 52
Reported as:: Mean · Number of work days missed in last month

Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Number of work days missed in last month	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	0.2 ± 0.9	0.1 ± 0.4

SecondaryNumber of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52

Number of work days with reduced productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 52
Reported as:: Mean · Work days with reduced work productivity

Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Work days with reduced work productivity	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	0.6 ± 2.1	0.3 ± 1.1

SecondaryInterference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52

The arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 52
Reported as:: Mean · units on a scale

Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
units on a scale	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	0.7 ± 1.4	0.5 ± 1.1

SecondaryNumber of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52

Number of days with no household work in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 52
Reported as:: Mean · Days with no household work

Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Days with no household work	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	1.1 ± 3.1	1.3 ± 3.4

SecondaryNumber of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52

Number of days with reduced household work productivity in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 52
Reported as:: Mean · Days with reduced household work

Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Days with reduced household work	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	1.3 ± 3.3	1.1 ± 2.9

SecondaryNumber of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52

Number of days missed of family/social/leisure activities in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 52
Reported as:: Mean · Activity days missed

Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Activity days missed	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	0.4 ± 2.5	0.2 ± 0.9

SecondaryNumber of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52

Number of days with hired outside help in the last month. The WPS-RA is a 9-item survey measuring the effect of Rheumatoid Arthritis (RA) and its treatment on the patient's work productivity.

Time frame:: Week 52
Reported as:: Mean · Days with hired outside help

Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
Days with hired outside help	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	0.1 ± 0.6	0.3 ± 2.1

SecondaryInterference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52

Time frame:: Week 52
Reported as:: Mean · units on a scale

Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52
units on a scale	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52	1.4 ± 2.0	1.2 ± 2.0

Adverse events

Collected over Adverse Events were collected from November 2010 through December 2012.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
RAPID3 to Assess Response to Cimzia	—	32/369 (8.7%)	126/369 (34.1%)
CDAI to Assess Response to Cimzia	—	39/367 (10.6%)	115/367 (31.3%)

Most frequent serious events

Showing 10 of 91

Most frequent serious events
Event	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Atrial fibrillationCardiac disorders	0/369	3/367
PneumoniaInfections and infestations	1/369	3/367
Non-cardiac chest painGeneral disorders	3/369	0/367
AnaemiaBlood and lymphatic system disorders	1/369	2/367
Small intestinal obstructionGastrointestinal disorders	0/369	2/367
Chest painGeneral disorders	1/369	2/367
Lupus-like syndromeMusculoskeletal and connective tissue disorders	0/369	2/367
CellulitisInfections and infestations	2/369	1/367
Cardiac failure congestiveCardiac disorders	0/369	1/367
Acute myocardial infarctionCardiac disorders	0/369	1/367

Most frequent other events

Most frequent other events
Event	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia
Urinary tract infectionInfections and infestations	39/369	38/367
Upper respiratory tract infectionInfections and infestations	37/369	38/367
SinusitisInfections and infestations	28/369	20/367
ArthralgiaMusculoskeletal and connective tissue disorders	24/369	10/367
BronchitisInfections and infestations	10/369	22/367
Rheumatoid arthritisMusculoskeletal and connective tissue disorders	19/369	5/367

Baseline characteristics

The Baseline Characteristics consists of the Safety Set (SS). SS consists of all subjects that received at least 1 dose of study medication.

Age, Categorical
Age, Categorical(Participants)	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia	Total
<=18 years	0	1	1
Between 18 and 65 years	295	276	571
>=65 years	74	90	164

Age, Continuous
Age, Continuous(years)	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia	Total
Mean	54.1 ± 12.5	55.7 ± 12.8	54.9 ± 12.7

Sex: Female, Male
Sex: Female, Male(Participants)	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia	Total
Female	280	293	573
Male	89	74	163

Region of Enrollment
Region of Enrollment(participants)	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia	Total
United States	369	367	736

Weight
Weight(Kilogram)	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia	Total
Mean	84.08 ± 21.35	80.17 ± 19.23	82.13 ± 20.40

Height
Height(Centimeters)	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia	Total
Mean	164.94 ± 9.91	164.00 ± 9.25	164.47 ± 9.59

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/ m^2)	RAPID3 to Assess Response to Cimzia	CDAI to Assess Response to Cimzia	Total
Mean	30.87 ± 7.23	29.82 ± 6.90	30.34 ± 7.08

Study locations

110 sites

137
Birmingham, Alabama, United States
166
Huntsville, Alabama, United States
165
Peoria, Arizona, United States
216
Tucson, Arizona, United States
168
Hot Springs, Arkansas, United States
241
Jonesboro, Arkansas, United States
153
Little Rock, Arkansas, United States
111
Covina, California, United States
208
Escondido, California, United States
103
Fullerton, California, United States
155
Huntington Beach, California, United States
202
La Mesa, California, United States
203
Loma Linda, California, United States
233
Los Angeles, California, United States
105
Palm Desert, California, United States
229
Roseville, California, United States
113
Sacramento, California, United States
127
San Diego, California, United States
106
Santa Maria, California, United States
172
Santa Monica, California, United States
212
Upland, California, United States
231
Van Nuys, California, United States
158
Whittier, California, United States
121
Bridgeport, Connecticut, United States
200
Bridgeport, Connecticut, United States
107
Danbury, Connecticut, United States
195
Danbury, Connecticut, United States
138
Hamden, Connecticut, United States
218
Lewes, Delaware, United States
108
Aventura, Florida, United States
120
Dunedin, Florida, United States
101
Ocala, Florida, United States
225
Orange Park, Florida, United States
227
Ormond Beach, Florida, United States
184
Palm Harbor, Florida, United States
145
Sarasota, Florida, United States
191
Tampa, Florida, United States
236
Vero Beach, Florida, United States
144
Atlanta, Georgia, United States
232
Atlanta, Georgia, United States
157
Lawrenceville, Georgia, United States
217
Coeur d'Alene, Idaho, United States
206
Idaho Falls, Idaho, United States
193
Rock Island, Illinois, United States
207
Springfield, Illinois, United States
186
Elizabethtown, Kentucky, United States
204
Lexington, Kentucky, United States
230
Louisville, Kentucky, United States
149
Cumberland, Maryland, United States
237
Hagerstown, Maryland, United States
197
Wheaton, Maryland, United States
118
Mansfield, Massachusetts, United States
132
Worcester, Massachusetts, United States
140
Lansing, Michigan, United States
226
Petoskey, Michigan, United States
114
Saint Clair Shores, Michigan, United States
188
Bridgeton, Missouri, United States
109
Saint Louis, Missouri, United States
133
Saint Louis, Missouri, United States
124
Lincoln, Nebraska, United States
205
Reno, Nevada, United States
159
Lebanon, New Hampshire, United States
189
Nashua, New Hampshire, United States
143
Clifton, New Jersey, United States
125
Albuquerque, New Mexico, United States
175
Albany, New York, United States
139
Binghamton, New York, United States
116
Brooklyn, New York, United States
167
Brooklyn, New York, United States
196
Johnson City, New York, United States
174
New York, New York, United States
104
Orchard Park, New York, United States
135
Plainview, New York, United States
215
Rochester, New York, United States
178
Charlotte, North Carolina, United States
210
Durham, North Carolina, United States
234
Hickory, North Carolina, United States
102
Monroe, North Carolina, United States
152
Bethlehem, Pennsylvania, United States
112
Duncansville, Pennsylvania, United States
219
Erie, Pennsylvania, United States
128
Philadelphia, Pennsylvania, United States
147
Sellersville, Pennsylvania, United States
213
Willow Grove, Pennsylvania, United States
235
Wyomissing, Pennsylvania, United States
198
Charleston, South Carolina, United States
228
Columbia, South Carolina, United States
130
Hendersonville, Tennessee, United States
129
Jackson, Tennessee, United States
162
Amarillo, Texas, United States
110
Austin, Texas, United States
156
Austin, Texas, United States
192
Dallas, Texas, United States
185
El Paso, Texas, United States
122
Houston, Texas, United States
170
Houston, Texas, United States
123
Mesquite, Texas, United States
115
Nassau Bay, Texas, United States
117
San Antonio, Texas, United States
119
San Antonio, Texas, United States

Showing the first 100 of 110 sites.

References and documents

Publications

Curtis JR, Herrem C, Ndlovu 'N, O'Brien C, Yazici Y. A somatization comorbidity phenotype impacts response to therapy in rheumatoid arthritis: post-hoc results from the certolizumab pegol phase 4 PREDICT trial. Arthritis Res Ther. 2017 Sep 29;19(1):215. doi: 10.1186/s13075-017-1412-z. PubMed 28962590 ↗
Curtis JR, Churchill M, Kivitz A, Samad A, Gauer L, Gervitz L, Koetse W, Melin J, Yazici Y. A Randomized Trial Comparing Disease Activity Measures for the Assessment and Prediction of Response in Rheumatoid Arthritis Patients Initiating Certolizumab Pegol. Arthritis Rheumatol. 2015 Dec;67(12):3104-12. doi: 10.1002/art.39322. PubMed 26316013 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01255761
Lead sponsor: UCB Pharma
Responsible party: Sponsor
First posted: Dec 7, 2010
Start date: Nov 2010
Primary completion: Oct 2012
Completion: Dec 2012
Results posted: Mar 7, 2014
Last update: Jul 31, 2018

Study contacts

UCB Clinical Trial Call Center

study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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