Status:
COMPLETED
Efficacy Confirmation Trial of CDP870 as add-on Medication to 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:
PHASE2
PHASE3
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 R...
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 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
- 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 2011
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT00791999
Start Date
November 1 2008
End Date
January 1 2011
Last Update
August 10 2012
Active Locations (8)
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1
Chubu Region, Japan
2
Chugoku Region, Japan
3
Hokkaido Region, Japan
4
Kanto Region, Japan