An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
NCT ID: NCT01909427
Last Updated: 2016-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
257 participants
INTERVENTIONAL
2013-06-30
2015-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis
NCT01975610
An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis
NCT00207714
Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis
NCT00487825
A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
NCT00718718
Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
NCT00928512
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo/CNTO 6785 200 mg+Methotrexate (MTX)
Placebo
Placebo subcutaneous injections (SC) every 4 weeks through Week 12
CNTO 6785 200 mg
CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28
Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
CNTO 6785 200 mg+MTX
CNTO 6785 200 mg
CNTO 6785 200 mg SC every 4 weeks through Week 28
Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
CNTO 6785 100 mg+MTX
CNTO 6785 100 mg
CNTO 6785 100 mg SC every 4 weeks through Week 28
Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
CNTO 6785 50 mg+MTX
CNTO 6785 50 mg
CNTO 6785 50 mg SC every 4 weeks through Week 28
Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
CNTO 6785 15 mg+MTX
CNTO 6785 15 mg
CNTO 6785 15 mg SC every 4 weeks through Week 28
Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Placebo subcutaneous injections (SC) every 4 weeks through Week 12
CNTO 6785 200 mg
CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28
CNTO 6785 200 mg
CNTO 6785 200 mg SC every 4 weeks through Week 28
CNTO 6785 100 mg
CNTO 6785 100 mg SC every 4 weeks through Week 28
CNTO 6785 50 mg
CNTO 6785 50 mg SC every 4 weeks through Week 28
CNTO 6785 15 mg
CNTO 6785 15 mg SC every 4 weeks through Week 28
Methotrexate (MTX)
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Buenos Aires, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Córdoba, , Argentina
La Capital, , Argentina
San Juan, , Argentina
Barranquilla, , Colombia
Bogotá, , Colombia
Medellín, , Colombia
Jihlava, , Czechia
Prague, , Czechia
Cebu, , Philippines
Iloilo City, , Philippines
Lipa City, , Philippines
Quezon City, , Philippines
Bydgoszcz, , Poland
Grodzisk Mazowiecki, , Poland
Lodz, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Barnaul, , Russia
Kemerovo, , Russia
Kursk, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Petrozavodsk, , Russia
Saint Petersburg, , Russia
Yaroslavl, , Russia
Yekaterinburg, , Russia
Bangkok, , Thailand
Chiang Mai, , Thailand
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CNTO6785ARA2001
Identifier Type: OTHER
Identifier Source: secondary_id
2012-003629-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR100935
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.