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

Phase 2

Completed

Interventions: Drug: CDP870 400mg
Drug: CDP870 100mg
Drug: CDP870 200mg
Drug: Placebo of CDP870

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
CDP870 400mg	CDP870 400mg	400mg CDP870 given every 2 weeks
CDP870 100mg	CDP870 100mg	200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
CDP870 200mg	CDP870 200mg	400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
Placebo	Placebo of CDP870	Placebo given every 2 weeks

Primary Outcome Measures

Name	Time	Method
American College of Rheumatology 20% (ACR20) Response at Week 12	Baseline, 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)

Secondary Outcome Measures

Name	Time	Method
American College of Rheumatology 20% (ACR20) Response at Week 24	Baseline, 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)