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

NCT00941707 | Terminated Phase 2 DMC

• 3 other identifiers: CR0164142009-012118-2738518168ARA2001
• Study Type: interventional
• Target: 86
• Locations: 10 countries
• Sites: 34

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; JNJ-38518168

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Disease Activity Index Score (DAS28) C-Reactive Protein (CRP) at Week 12

  The DAS28 based on CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and participant's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.

  Baseline and Week 12

Secondary Outcomes (10)

• Percentage of Participants With DAS28 (CRP) Response

  Week 12

• Percentage of Participants With DAS28 (ESR) Response

  Week 12

• Change From Baseline in DAS28 (ESR) Score at Week 12

  Baseline and Week 12

• Percentage of Participants Achieving American College of Rheumatology (ACR20) Response

  Week 12

• Percentage of Participants Achieving ACR50 Response

  Week 12

Study Arms (2)

JNJ-38518168

EXPERIMENTAL

Drug: JNJ 38518168

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JNJ 38518168 DRUG

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

JNJ-38518168

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (34)

Unknown Facility

Liège, Belgium

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Brno, Czechia

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Kladno, Czechia

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Prague, Czechia

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Uherské Hradiště, Czechia

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Zlín, Czechia

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Dublin, Ireland

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Amsterdam-Zuidoost, Netherlands

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Bialystok, Poland

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Bydgoszcz, Poland

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Elblag, Poland

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Lublin, Poland

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Torun, Poland

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Kemerovo, Russia

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Moscow, Russia

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Novosibirsk, Russia

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Petrozavodsk, Russia

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Saint Petersburg, Russia

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Yaroslavl, Russia

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Yekaterinburg, Russia

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Pucheon, South Korea

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Seoul, South Korea

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Suwon, South Korea

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Barcelona, Spain

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Guadalajara, Spain

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Santiago de Compostela, Spain

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Seville, Spain

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Changhua, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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London, United Kingdom

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Middlesbrough, United Kingdom

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Salford, United Kingdom

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Wigan, United Kingdom

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 20, 2009
• Study Start: February 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

NL (1); ES (4); KR (3); CZ (5); TW (3); BE (1); PL (5); RU (7); GB (4); IE (1)