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

• ClinicalTrials.gov Identifier: NCT01255761
• Recruitment Status: Completed
• First Posted: December 7, 2010
• Results First Posted: March 7, 2014
• Last Update Posted: July 31, 2018
• Sponsor: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Biological: Certolizumab Pegol (CZP)	Phase 4

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 736 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: November 2010
• Actual Primary Completion Date: October 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

   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.

2. 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: Baseline (Week 0) to 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.

Secondary Outcome Measures :

1. 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 [ Time Frame: Baseline (Week 0) to 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.

2. Responders at Week 12 Achieving Remission (Disease Activity Score 28 [Erythrocyte Sedimentation Rate] < 2.6) at Week 52 [ Time Frame: Baseline (Week 0) to 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.

3. 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 [ Time Frame: Baseline (Week 0) to 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.

4. 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 ]

   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.

5. 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 ]

   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.

6. Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 12 [ Time Frame: Baseline (Week 0) to 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.

7. Change From Baseline in Clinical Disease Activity Index (CDAI) Assessed at Week 52 [ Time Frame: Baseline (Week 0) to 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.

8. Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 12 [ Time Frame: Baseline (Week 0) to 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.

9. Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID3) Assessed at Week 52 [ Time Frame: Baseline (Week 0) to 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.

10. 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 ]
    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.
11. 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 ]
    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.
12. 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 ]
    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.
13. 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 ]
    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.
14. Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 12 [ Time Frame: 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.

15. Percentage of Subjects With CDAI (Clinical Disease Activity Index) Low Disease Activity (CDAI ≤ 10) at Week 52 [ Time Frame: 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.

16. Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 12 [ Time Frame: 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.

17. Percentage of Subjects With CDAI (Clinical Disease Activity Index) Remission (CDAI ≤ 2.8) at Week 52 [ Time Frame: 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.

18. Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 12 [ Time Frame: 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.

19. Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Low Disease Activity (RAPID3 ≤ 6.0) at Week 52 [ Time Frame: 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.

20. Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 12 [ Time Frame: 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.

21. Percentage of Subjects With RAPID3 (Routine Assessment of Patient Index Data) Remission (RAPID3 ≤ 3.0) at Week 52 [ Time Frame: 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.

22. Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: 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.
23. Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: 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.
24. Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: 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.
25. Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: 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.
26. Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: 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.
27. Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: 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.
28. Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: 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.
29. Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 12 [ Time Frame: 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.

30. Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: 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.
31. Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: 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.
32. Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: 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.

33. Number of Days With No Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: 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.
34. Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: 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.
35. Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: 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.
36. Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: 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.
37. Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52 [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

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

Saint Clair Shores, Michigan, United States

United States, Missouri

188

Bridgeton, Missouri, United States

109

Saint Louis, Missouri, United States

133

Saint 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

Albuquerque, New Mexico, United States

United States, New York

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

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

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT01255761
• Other Study ID Numbers: RA0064
• First Posted: December 7, 2010
• Results First Posted: March 7, 2014
• Last Update Posted: July 31, 2018
• Last Verified: March 2018

Keywords provided by UCB Pharma:

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; Certolizumab Pegol; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents