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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo of CDP870; Drug: CDP870

• Registration Number: NCT00791921
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-14
• Study First Posted: 2008-11-17
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2012-06-18
• Results First Submitted QC: 2012-06-27
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-05
• Results First Posted: 2012-08-06
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

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)