Status:
COMPLETED
Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
Lead Sponsor:
UCB Pharma
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of CDP6038 treatment in adult subjects with active rheumatoid arthritis who have had an inadequate r...
Detailed Description
CDP6038 is a protein (antibody) that blocks interleukin-6 (IL-6), a substance involved in the inflammation associated with rheumatoid arthritis. This is a multicenter, 12-week, randomized, double-blin...
Eligibility Criteria
Inclusion
- Have a diagnosis of rheumatoid arthritis (according to the 1987 ACR classification criteria OR a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for rheumatoid arthritis ) for at least 6 months prior to screening
- Must have been treated with MTX 12.5-25 mg/week, for at least 6 weeks prior to screening. Doses of 10 to \< 12.5mg/week are allowed if there is documented intolerance
- Have moderately to severely active rheumatoid arthritis disease with at least 6 tender and 6 swollen joints
- CRP ≥1.2 times the upper limit of normal (central laboratory) or erythrocyte sedimentation rate of more than 28mm/hour
- Intolerant or inadequate response to treatment (ie, TNF blocker failure)≥1 licensed TNF-blocker therapies within 2 years of screening
Exclusion
- Have a diagnosis of any other inflammatory arthritis or secondary, noninflammatory type of arthritis, such as psoriatic arthritis, lupus, gout, or ankylosing spondylitis
- Wheelchair bound or bedridden.
- Disease modifying antirheumatic drugs (DMARDs) other than MTX.
- Treatment with tocilizumab or any other anti-IL-6 investigational therapies at any time.
- Treatment with other biologics within 4-24 weeks (depending on the biologic)
- History of ongoing, chronic or recurrent infections or recent serious or life-threatening infection
- Known concurrent acute or chronic viral hepatitis B or C infection or human immunodeficiency virus (HIV) infection.
- Vaccinations (other than injectable influenza or pneumococcal) within 8 weeks prior to screening or plan to receive vaccines during the study
- Concurrent or history of malignancy with the exception of nonmelanoma skin cancer successfully treated more than 2 years prior to screening or cervical cancer successfully treated more than 5 years prior to screening.
- History of chronic alcohol abuse or drug addiction within the last 1 year or current drug addiction or use of illicit drugs.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT01242488
Start Date
November 1 2010
End Date
June 1 2012
Last Update
July 17 2024
Active Locations (82)
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Mesa, Arizona, United States
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Paradise Valley, Arizona, United States
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Scottsdale, Arizona, United States
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Hot Springs, Arkansas, United States