Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

Study Overview
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Brief Summary
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The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.

Official Title
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A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: CDP870
* Drug: Placebo of CDP870


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have a diagnosis of adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria. Subjects must have active RA disease as defined by: At least 6 tender joints and 6 swollen joints ESR of 28 mm/hour or CRP of 2.0 mg/dL Subjects who have failed to respond or have been resistant to at least one DMARD (including MTX) Subjects in whom MTX cannot be administered for any of the reasons(incomplete response/safety concerns) Exclusion Criteria: Patients who have a diagnosis of any other inflammatory arthritis Patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia) Patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy) Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure Patients who currently have, or who have a history of, tuberculosis Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease) Patients who currently have, or who have a history of, malignancy Female patients who are breastfeeding or pregnant, who are of childbearing potential Patients who previously received treatment with 2 or more anti-TNFα drugs or who previously failed to respond to treatment with 1 or more aint-TNFα drugs.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDP870 200mg<br>400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks | Drug: CDP870<br>* 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 subcutaneously(SC)<br>|
| Placebo Comparator: Placebo<br>Placebo of CDP870 | Drug: Placebo of CDP870<br>* Placebo given every 2 weeks until Week22 (SC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American College of Rheumatology 20% (ACR20) Response at Week 12 | ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS) | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American College of Rheumatology 20% (ACR20) Response at Week 24 | ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS) | Baseline, Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Certolizumab Pegol, Cimzia