An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis

NCT ID: NCT00941707

Last Updated: 2013-04-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-11-30

Brief Summary

The purpose of this study is to evaluate the efficacy, tolerability and safety of JNJ-38518168 compared with placebo in adult participants with active rheumatoid arthritis (long time systemic disease of the joints, marked by inflammatory changes in the synovial membranes and bones) despite methotrexate (MTX) therapy.

Detailed Description

This is a multi-center (when more than 1 hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) and parallel-group (each group of participants will be treated at the same time) study. The study will consist of 3 phases; Screening phase (3 weeks), Treatment phase (12 weeks) and Follow-up phase (4 weeks). Each participant will be enrolled in the study for approximately 19 weeks. Participants with active rheumatoid arthritis despite MTX therapy will receive JNJ-38518168, 100 milligram (mg) per day or matching placebo capsules once daily for 12 weeks. Efficacy will be primarily evaluated by change from Baseline in disease activity index score C-reactive protein at Week 12. Participants' safety will be monitored throughout the study.

Conditions

Rheumatoid Arthritis

Study Design

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

Study Groups

JNJ-38518168

Group Type: EXPERIMENTAL

JNJ 38518168

Intervention Type: DRUG

JNJ-38518168 100 milligram (mg) capsules orally (by mouth) once daily for 12 weeks.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsules matching to JNJ-38518168 orally once daily for 12 weeks.

Interventions

JNJ 38518168

JNJ-38518168 100 milligram (mg) capsules orally (by mouth) once daily for 12 weeks.

Intervention Type: DRUG

Placebo

Placebo capsules matching to JNJ-38518168 orally once daily for 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants diagnosed with rheumatoid arthritis (RA) according to the revised 1987 criteria of the ARA (Arnett et al, 1988) for at least 6 months at Screening
• Participants who have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 milligram (mg) per week inclusive, for a minimum of 4 months before Screening
• Participants if using non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics (drug used to control pain) regularly for RA, participants must have been on a stable dose for at least 2 weeks before the first dose of study medication
• Participants if using oral corticosteroids (compounds, usually hormonal, taken orally [by mouth] in order to block ovulation [discharge of an egg from the ovary] and prevent the occurrence of pregnancy [carrying an unborn baby]), must be on a stable dose of less than or equal to 10 mg per day of prednisone or another oral corticosteroid for at least 4 weeks before the first dose of study medication and continue with the same dose throughout the study. If not using corticosteroids at study initiation, the participant must have not received any oral corticosteroids for at least 4 weeks before the first dose of study medication
• Participants currently treated with folic acid at a minimum dose of 5 mg per week

Exclusion Criteria

• Participants having inflammatory disease other than RA
• Participant who have used any of the following medications: D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold salts, sulfasalazine, leflunomide, azathioprine, cyclosporine, tacrolimus, and mycophenolatemofetil
• Participant who have received intra-articular, intramuscular (into the muscle), or intravenous (into the vein) corticosteroids, including adrenocorticotropic hormone (hormone made by the brain that activates the adrenal glands) within 4 weeks before the first dose of the study medication
• Participants who have been treated with any other investigational drug or medical device within 4 weeks or 5 half-lives of the drug, whichever is longer before the first dose of study medication
• Participants who have undergone surgical treatments for RA including synoviectomy (surgical removal of a part of the synovial membrane of a joint) and arthroplasty (surgery to fix a joint) within 3 months before the first dose of study medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Liège, , Belgium

Brno, , Czechia

Kladno, , Czechia

Prague, , Czechia

Uherské Hradiště, , Czechia

Zlín, , Czechia

Dublin, , Ireland

Amsterdam-Zuidoost, , Netherlands

Bialystok, , Poland

Bydgoszcz, , Poland

Elblag, , Poland

Lublin, , Poland

Torun, , Poland

Kemerovo, , Russia

Moscow, , Russia

Novosibirsk, , Russia

Petrozavodsk, , Russia

Saint Petersburg, , Russia

Yaroslavl, , Russia

Yekaterinburg, , Russia

Pucheon, , South Korea

Seoul, , South Korea

Suwon, , South Korea

Barcelona, , Spain

Guadalajara, , Spain

Santiago de Compostela, , Spain

Seville, , Spain

Changhua, , Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

London, , United Kingdom

Middlesbrough, , United Kingdom

Salford, , United Kingdom

Wigan, , United Kingdom

Countries

Belgium; Czechia; Ireland; Netherlands; Poland; Russia; South Korea; Spain; Taiwan; United Kingdom

Other Identifiers

2009-012118-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

38518168ARA2001

Identifier Type: -

Identifier Source: secondary_id

CR016414

Identifier Type: -

Identifier Source: org_study_id