A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects (PREDICT)
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Biological: Certolizumab Pegol (CZP) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving Cimzia |
- Response at Week 12 as assessed by randomized tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)] [ Time Frame: Baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]
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.
- 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 [ Time Frame: Week 12 to Week 52 ] [ Designated as safety issue: No ]
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.
- Responders at Week 12 with Non-low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 3.2) at Week 52 [ Time Frame: Week 12 to Week 52 ] [ Designated as safety issue: No ]
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.
- Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52 [ Time Frame: Week 12 to Week 52 ] [ Designated as safety issue: No ]
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.
- Responders at Week 12 with Non-remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] > 2.6) at Week 52 [ Time Frame: Week 12 to Week 52 ] [ Designated as safety issue: No ]
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.
- Change from Baseline in the Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] assessed at Week 12 [ Time Frame: Baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]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.
- Change from Baseline in Disease Activity Score 28 Erythrocyte Sedimentation Rate [DAS28 (ESR)] assessed at Week 52 [ Time Frame: Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]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.
- Change from Baseline in Clinical Disease Activity Index (CDAI) assessed at Week 12 [ Time Frame: Baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]
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.
- Change from Baseline in Clinical Disease Activity Index (CDAI) assessed at Week 52 [ Time Frame: Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]
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.
- Change from Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) assessed at Week 12 [ Time Frame: Baseline (Week 0) to Week 12 ] [ Designated as safety issue: No ]
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.
- Change from Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) assessed at Week 52 [ Time Frame: Baseline (Week 0) to Week 52 ] [ Designated as safety issue: No ]
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.
- Percentage of subjects with DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Low Disease Activity (DAS28[ESR] ≤ 3.2) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]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.
- Percentage 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 ] [ Designated as safety issue: No ]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.
- Percentage of subjects with DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS [ESR] < 2.6) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]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.
- Percentage of subjects with DAS28(ESR) (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]) Remission (DAS28[ESR] < 2.6) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]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.
- Percentage of subjects with CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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.
- Percentage of subjects with CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
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.
- Percentage of subjects with CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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.
- Percentage of subjects with CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
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.
- Percentage of subjects with RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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.
- Percentage of subjects with RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
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.
- Percentage of subjects with RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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.
- Percentage of subjects with RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
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.
- Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]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.
- Number of Work Days with Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]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.
- Interference with Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]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.
- Number of Days with No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]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.
- Number of Days with Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]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.
- Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]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.
- Number of Days with Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]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.
- Interference with Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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.
- Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]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.
- Number of Work Days with Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]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.
- Interference with Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
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.
- Number of Days with No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]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.
- Number of Days with Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]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.
- Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]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.
- Number of Days with Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]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.
- Interference with Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
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.
| Enrollment: | 736 |
| Study Start Date: | November 2010 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
400 mg subcutaneous injection at Weeks 0, 2 and 4 200 mg subcutaneous injection every two weeks, Week 6 through Week 52 Other Name: Cimzia
|
|
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)
400 mg subcutaneous injection at Weeks 0, 2 and 4 200 mg subcutaneous injection every two weeks, Week 6 through Week 52 Other Name: Cimzia
|
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)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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:
- 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
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| 137 | |
| Birmingham, Alabama, United States | |
| 166 | |
| Huntsville, Alabama, United States | |
| United States, Arizona | |
| 165 | |
| Peoria, Arizona, United States | |
| 216 | |
| Tucson, Arizona, United States | |
| United States, Arkansas | |
| 168 | |
| Hot Springs, Arkansas, United States | |
| 241 | |
| Jonesboro, Arkansas, United States | |
| 153 | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| 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 | |
| United States, Connecticut | |
| 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 | |
| United States, Delaware | |
| 218 | |
| Lewes, Delaware, United States | |
| United States, Florida | |
| 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 | |
| United States, Georgia | |
| 144 | |
| Atlanta, Georgia, United States | |
| 232 | |
| Atlanta, Georgia, United States | |
| 157 | |
| Lawrenceville, Georgia, United States | |
| United States, Idaho | |
| 217 | |
| Coeur D'Alene, Idaho, United States | |
| 206 | |
| Idaho Falls, Idaho, United States | |
| United States, Illinois | |
| 193 | |
| Rock Island, Illinois, United States | |
| 207 | |
| Springfield, Illinois, United States | |
| United States, Kentucky | |
| 186 | |
| Elizabethtown, Kentucky, United States | |
| 204 | |
| Lexington, Kentucky, United States | |
| 230 | |
| Louisville, Kentucky, United States | |
| United States, Maryland | |
| 149 | |
| Cumberland, Maryland, United States | |
| 237 | |
| Hagerstown, Maryland, United States | |
| 197 | |
| Wheaton, Maryland, United States | |
| United States, Massachusetts | |
| 118 | |
| Mansfield, Massachusetts, United States | |
| 132 | |
| Worcester, Massachusetts, United States | |
| United States, Michigan | |
| 140 | |
| Lansing, Michigan, United States | |
| 226 | |
| Petoskey, Michigan, United States | |
| 114 | |
| St Clair Shores, Michigan, United States | |
| United States, Missouri | |
| 188 | |
| Bridgeton, Missouri, United States | |
| 109 | |
| St Louis, Missouri, United States | |
| 133 | |
| St Louis, Missouri, United States | |
| United States, Nebraska | |
| 124 | |
| Lincoln, Nebraska, United States | |
| United States, Nevada | |
| 205 | |
| Reno, Nevada, United States | |
| United States, New Hampshire | |
| 159 | |
| Lebanon, New Hampshire, United States | |
| 189 | |
| Nashua, New Hampshire, United States | |
| United States, New Jersey | |
| 143 | |
| Clifton, New Jersey, United States | |
| United States, New Mexico | |
| 125 | |
| Albuerqueque, New Mexico, United States | |
| United States, New York | |
| 175 | |
| Albany, New York, United States | |
| 139 | |
| Binghampton, 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 | |
| United States, North Carolina | |
| 178 | |
| Charlotte, North Carolina, United States | |
| 210 | |
| Durham, North Carolina, United States | |
| 234 | |
| Hickory, North Carolina, United States | |
| 102 | |
| Monroe, North Carolina, United States | |
| United States, Pennsylvania | |
| 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 | |
| United States, South Carolina | |
| 198 | |
| Charleston, South Carolina, United States | |
| 228 | |
| Columbia, South Carolina, United States | |
| United States, Tennessee | |
| 130 | |
| Hendersonville, Tennessee, United States | |
| 129 | |
| Jackson, Tennessee, United States | |
| United States, Texas | |
| 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 | |
| 161 | |
| San Antonio, Texas, United States | |
| 190 | |
| Victoria, Texas, United States | |
| 142 | |
| Waco, Texas, United States | |
| United States, Vermont | |
| 136 | |
| Burlington, Vermont, United States | |
| United States, Virginia | |
| 146 | |
| Arlington, Virginia, United States | |
| 150 | |
| Chesapeake, Virginia, United States | |
| United States, Washington | |
| 223 | |
| Kennewick, Washington, United States | |
| 134 | |
| Spokane, Washington, United States | |
| United States, West Virginia | |
| 221 | |
| Clarksburg, West Virginia, United States | |
| United States, Wisconsin | |
| 194 | |
| Glendale, Wisconsin, United States | |
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT01255761 History of Changes |
| Other Study ID Numbers: | RA0064 |
| Study First Received: | December 6, 2010 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by UCB, Inc.:
|
Certolizumab Pegol Cimzia Rheumatoid Arthritis CDAI RAPID3 |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Immunoglobulin Fab Fragments Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013