Status:
COMPLETED
Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy
Lead Sponsor:
UCB Japan Co. Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo.
Eligibility Criteria
Inclusion
- Have a diagnosis of adult-onset RA of at least 6 months' (24 weeks) duration as defined by the 1987 ACR classification criteria or a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA
- Must have moderately to severely active RA disease as defined by ≥6 tender joints (68-joint count) at Screening and Baseline, ≥6 swollen joints (66-joint count) at Screening and Baseline, CRP ≥1.2 times the upper limit of normal (ULN) or ESR \>28mm/hour
- Must be on an MTX dose of 6 to 16mg/week in Japan or 7.5 to 20mg/week in Korea and Taiwan, which has been stable for at least 6 weeks prior to Screening with a stable route of administration
- Must have had intolerance or inadequate response to treatment with 1 or more TNF-blocker therapies within 2 years of Screening
- Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception
Exclusion
- Have a diagnosis of any other inflammatory arthritis
- Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
- Disease modifying antirheumatic drug (DMARDs) other than methotrexate (MTX)
- Subjects with known concurrent acute or chronic viral hepatitis B or C infection
- Subject has known tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection
- Subjects with known history of or current clinically active infection
- Subjects at high risk of infection
- Subjects with known human immunodeficiency virus (HIV) or human T cell lymphotropic virus type 1 (HTLV 1) infection
- Have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted)
- Concurrent malignancy or a history of malignancy (with the exception of successfully treated carcinoma of the cervix more than 5 years prior to Screening or no more than 2 successfully treated basal cell carcinomas within 2 years prior to Screening
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT01463059
Start Date
October 1 2011
End Date
February 1 2013
Last Update
March 25 2013
Active Locations (39)
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1
102
Chiba, Japan
2
114
Fukuoka, Japan
3
115
Fukuoka, Japan
4
113
Hiroshima, Japan