Status:
COMPLETED
Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Collaborating Sponsors:
UCB Japan Co. Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20-74 years
Phase:
PHASE3
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 co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00791921
Start Date
November 1 2008
End Date
January 1 2010
Last Update
August 7 2012
Active Locations (7)
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1
Chube Region, Japan
2
Chugoku Region, Japan
3
Hokkaido Region, Japan
4
Kanto Region, Japan