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

Rheumatoid Arthritis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791921
• Other study ID #: CDP870-275-08-003
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2008
• Last updated: August 5, 2012
• Start date: November 2008
• Est. completion date: January 2010

Study information

• Verified date: August 2012
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

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 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-TNFa drugs or who previously failed to respond to treatment with 1 or more aint-TNFa drugs.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• CDP870
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 subcutaneously(SC)
• Placebo of CDP870
Placebo given every 2 weeks until Week22 (SC)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.	UCB Japan Co. Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No