Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

Study Overview
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Brief Summary
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The objective of this trial is to investigate the efficacy (American College of Rheumatology 20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of foreign data to the Japanese population.

Official Title
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A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Pharmacokinetics and Safety of CDP870 as add-on Medication to MTX in Japanese Active RA Patients Who Have an Incomplete Response to MTX.

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: CDP870 400mg
* Drug: CDP870 200mg
* Drug: CDP870 100mg
* 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 9 tender joints and 9 swollen joints ESR of 30 mm/hour or CRP of 1.5 mg/dL Subjects must have received treatment with MTX for at least 6 months prior to the start of study drug administration. The dose of MTX must have remain fixed for at least 2 months prior to the study and the dose of MTX should be within 6 to 8 mg/week. 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 100mg<br>200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks | Drug: CDP870 100mg<br>* 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC)<br>|
| Experimental: CDP870 200mg<br>400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks | Drug: CDP870 200mg<br>* 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week22 (SC)<br>|
| Experimental: CDP870 400mg<br>400mg CDP870 given every 2 weeks | Drug: CDP870 400mg<br>* 400mg CDP870 given every 2 weeks until Week22 (SC)<br>|
| Placebo Comparator: Placebo<br>Placebo given every 2 weeks | Drug: Placebo of CDP870<br>* 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