An Efficacy And Safety Study of CNTO6785 In Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
- Conditions
- Rheumatoid ArthritisMedDRA version: 14.1Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2012-003629-40-CZ
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
• Be a man or woman between 18 (at least 18 and the legal age of consent in the jurisdiction in which the study is taking place) and 80 years of age (or less if mandated by country-specific guidelines), inclusive.
• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
•Has inflammatory diseases other than RA, including, but not limited to adult onset Still’s disease (AOSD), Felty’s syndrome, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, and Lyme disease that might confound the evaluation of the benefit of study agent therapy.
• Has a history of juvenile idiopathic arthritis (JIA).
•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 including, but not limited to, brodalumab (AMG 827), infliximab, xekizumab, secukinumab, etanercept, adalimumab, golimumab, sirukumab, certolizumab pegol, tocilizumab, abatacept, anakinra, yisaipu, and ß-cell depleting therapies.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of CNTO 6785 on the signs and symptoms in subjects with active RA compared with placebo despite concomitant methotrexate (MTX) therapy;Secondary Objective: 1. To assess the safety and tolerability of CNTO 6785<br>2. To assess the impact of CNTO 6785 on physical function<br>3. To assess the pharmacokinetics (PK) and immunogenicity of <br> CNTO 6785 <br>4. To explore PK/pharmacodynamic (PD) relationship<br>;Primary end point(s): The proportion of participants who achieve an ACR 20 response ;Timepoint(s) of evaluation of this end point: At Week 16
- Secondary Outcome Measures
Name Time Method