An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: CNTO 6785 200 mg; Drug: Placebo; Drug: CNTO 6785 50 mg; Drug: CNTO 6785 100 mg; Drug: Methotrexate (MTX); Drug: CNTO 6785 15 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01909427

CNTO6785ARA2001 (Other Identifier)

CR100935

2012-003629-40 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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 appears identical to a study drug but has no active ingredients), multicenter study. The study will consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase. Approximately 250 participants with active RA despite MTX therapy will be randomly assigned to receive placebo or CNTO 6785 during the double-blind treatment phase. The maximum period of active treatment will be 28 weeks. The maximum duration of study participation will be 44 weeks. Participant safety will be monitored throughout the study.

Enrollment: 257 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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257 participants in 5 patient groups, including a placebo group

Placebo/CNTO 6785 200 mg+Methotrexate (MTX)

Placebo Comparator group

Treatment:

Drug: CNTO 6785 200 mg

Drug: Placebo

Drug: Methotrexate (MTX)

Drug: CNTO 6785 200 mg

CNTO 6785 200 mg+MTX

Experimental group

Treatment:

Drug: CNTO 6785 200 mg

Drug: Methotrexate (MTX)

Drug: CNTO 6785 200 mg

CNTO 6785 100 mg+MTX

Experimental group

Treatment:

Drug: CNTO 6785 100 mg

Drug: Methotrexate (MTX)

CNTO 6785 50 mg+MTX

Experimental group

Treatment:

Drug: CNTO 6785 50 mg

Drug: Methotrexate (MTX)

CNTO 6785 15 mg+MTX

Experimental group

Treatment:

Drug: Methotrexate (MTX)

Drug: CNTO 6785 15 mg