Status:
COMPLETED
An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy and safety of CNTO6785 in participants with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.
Detailed Description
This is a randomized (participants are assigned to treatment by chance), double-blind (participants and study personnel will not know which treatments are being given), placebo-controlled (a placebo a...
Eligibility Criteria
Inclusion
- Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the American Rheumatism Association) and have had RA for at least 6 months prior to the date of signing the informed consent at screening
- Have active RA defined study as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline; and serum C-reactive protein (CRP) ≥ 0.8 mg/dL at screening or erythrocyte sedimentation rate (ESR) ≥ 28 mm in the first hour at screening or baseline
- Have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 mg/week, inclusive, for a minimum of 6 months prior to screening and must have a stable MTX dose for a minimum of 6 weeks prior to the first dosing with study agent
Exclusion
- Has inflammatory diseases other than RA, that might confound the evaluation of the benefit of study agent therapy
- Has a diagnosis of fibromyalgia
- Has a recent history (within 12 months prior to screening) of uncontrolled, chronic disease including, but not limited to, pulmonary, psychiatric, and metabolic disturbances, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, or urological diseases that the investigator believes are clinically significant
- At screening, the results of laboratory tests must meet protocol-specified criteria
- Has ever received any approved or investigational biologic agent for a rheumatic indication
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT01909427
Start Date
June 1 2013
End Date
May 1 2015
Last Update
March 2 2016
Active Locations (32)
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1
Buenos Aires, Argentina
2
Ciudad Autonoma Buenos Aires, Argentina
3
Córdoba, Argentina
4
La Capital, Argentina