A Dose Range Finding Study of JNJ-39758979 in Patients With Active Rheumatoid Arthritis Currently Treated With Methotrexate

NCT ID: NCT01480388

Last Updated: 2016-12-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-03-31

Brief Summary

The purpose of the study is to assess the efficacy, safety and tolerability of JNJ-39758979 at doses of 10, 30, 100, and 300 mg/day compared with placebo (inactive medical substance) in patients with active rheumatoid arthritis despite concomitant treatment with methotrexate (MTX).

Detailed Description

This is a double-blind (neither physician nor patient knows if the patient is receiving JNJ-39758979 or placebo), multicenter, randomized (patients are assigned to treatment by chance), placebo-controlled, dose range finding study of JNJ-39758979 in patients with stable methotrexate treatment through Week 24. The study will consist of 4 periods: a screening period, a 24-week placebo-controlled period, a 24-week extension period, and a 5-week safety follow-up period. The duration of participation in the study for an individual patient will be up to 59 weeks (including screening). All patients will be randomly assigned in a 1:1:1:1:1 ratio to receive placebo or JNJ-39758979 10 mg, 30 mg, 100 mg, or 300 mg once daily. At Week 24, all patients remaining in the placebo group will start to receive JNJ-39758979 300 mg/day. Safety assessments and evaluations to determine the efficacy of JNJ-39758979 to reduce the signs and symptoms of rheumatoid arthritis will be performed at study visits. The extension and safety follow-up periods of this study will continue through Week 53 in order to assess the safety and for maintenance of efficacy of patients.

Conditions

Active Rheumatoid Arthritis; Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Swollen and tender joints; Dose range finding study; Concurrent treatment with methotrexate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo/JNJ-39758979 (300 mg/d)

Intervention Type: DRUG

Form = tablet, route = oral adminstration placebo once daily from Week 0 to Week 24 followed by JNJ-39758979 300 mg once daily from Week 24 to Week 48.

JNJ-39758979 (10 mg/d)

Group Type: EXPERIMENTAL

JNJ-39758979 (10 mg)

Intervention Type: DRUG

Form = tablet, route = oral adminstration once daily up to 48 weeks

JNJ-39758979 (30 mg/d)

Group Type: EXPERIMENTAL

JNJ-39758979 (30 mg)

Intervention Type: DRUG

Form = tablet, route = oral adminstration once daily up to 48 weeks

JNJ-39758979 (100 mg/d)

Group Type: EXPERIMENTAL

JNJ-39758979 (100 mg)

Intervention Type: DRUG

Form = tablet, route = oral adminstration once daily up to 48 weeks

JNJ-39758979 (300 mg/d)

Group Type: EXPERIMENTAL

JNJ-39758979 (300 mg)

Intervention Type: DRUG

Form = tablet, route = oral adminstration once daily for 48 weeks

Interventions

Placebo/JNJ-39758979 (300 mg/d)

Form = tablet, route = oral adminstration placebo once daily from Week 0 to Week 24 followed by JNJ-39758979 300 mg once daily from Week 24 to Week 48.

Intervention Type: DRUG

JNJ-39758979 (10 mg)

Form = tablet, route = oral adminstration once daily up to 48 weeks

Intervention Type: DRUG

JNJ-39758979 (30 mg)

Form = tablet, route = oral adminstration once daily up to 48 weeks

Intervention Type: DRUG

JNJ-39758979 (100 mg)

Form = tablet, route = oral adminstration once daily up to 48 weeks

Intervention Type: DRUG

JNJ-39758979 (300 mg)

Form = tablet, route = oral adminstration once daily for 48 weeks

Intervention Type: DRUG

Other Intervention Names

Inactive medical substance

Eligibility Criteria

Inclusion Criteria

• Has a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening.
• Positive test for either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum at screening.
• Has active RA defined as persistent disease activity with the following criteria: at least 6 swollen and 6 tender joints, and serum CRP ≥ 0.70 mg/dL at screening.
• Has been treated with and tolerated methotrexate (MTX) treatment at dosages of 10 to 25 mg/week for a minimum of 6 months prior to screening and must be on a stable dose for a minimum of 8 weeks prior to screening
• Must be post-menopausal or if pre-menopausal, must use an acceptable form of birth control
• Has completed at least 5 days of daily pain diary in the 10 days prior to randomization.

Exclusion Criteria

• Has inflammatory diseases other than RA, such as Lupus.
• Is currently receiving treatment for RA other than methotrexate, NSAIDS, or oral corticosteroids such as prednisone, or pain medicines.
• Has ever received any biologic agent for a rheumatic indication.
• Has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled.
• Has moderate or severe renal insufficiency
• Has a recent (within 2 months) serious infection
• Has had an opportunistic infection.
• Has had cancer within the past 5 years (except certain skin or cervical conditions)
• Has abused substances or alcohol within the past 2 years
• Has active Hepatitis B or C infection
• Has had active tuberculosis
• Has had exposure to tuberculosis without preventative treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Development, L.L.C. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Countries

United States

Other Identifiers

39758979ARA2001

Identifier Type: OTHER

Identifier Source: secondary_id

2011-002849-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR018814

Identifier Type: -

Identifier Source: org_study_id