A Study of the Safety and Efficacy of JNJ-38518168 in the Treatment of Adult Patients With Rheumatoid Arthritis


Tracking Information

Start Date  ICMJENovember 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: July 30, 2009)		Change from baseline in DAS28 (using CRP) score [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: July 17, 2009)		Change from baseline in DAS28 (using CRP) score. [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
Change HistoryComplete list of historical versions of study NCT00941707 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: July 17, 2009)		To assess the efficacy of JNJ-38518168 as measured by ACR 20, 50, 70, 90 response rates and other efficacy assessments. [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of the Safety and Efficacy of JNJ-38518168 in the Treatment of Adult Patients With Rheumatoid Arthritis
Official Title  ICMJEA Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy
Brief Summary

The purpose of this study is to evaluate the effectiveness, tolerability and safety of JNJ 38518168 compared to placebo in treatment of adult patients with rheumatoid arthritis.

Detailed Description

This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study in 90 patients with active rheumatoid arthritis despite methotrexate therapy with a synovial biopsy substudy of 18 patients. JNJ-38518168 at a dose of 100 mg/day for up to 12 weeks compared to placebo that will include an additional 4-week follow-up

Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJERheumatoid Arthritis, Arthritis,
Intervention  ICMJEDrug: JNJ 38518168 or placebo

Recruitment Information

Estimated Enrollment  ICMJE90
Estimated Completion DateNovember 2010
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a diagnosis of Rheumatoid Arthritis (RA)
  • have been treated with and tolerated methotrexate (MTX) treatment at dosages between 7.5 to 25 mg/week inclusive, for a minimum of 4 months prior to Screening
  • if using non-steroidal anti-inflammatory drugs (NSAIDs) regularly for RA or other conditions, subjects must have been on a stable dose for at least 2 weeks prior to the first dose of study medication
  • If using oral corticosteroids, must be on a stable dose of =10 mg/day of prednisone or another oral corticosteroid for at least 4 weeks prior to the first dose of study medication, and continue with the same dose throughout the study. If not using corticosteroids at study initiation, the subject must have not received oral corticosteroids for at least 4 weeks prior to the first dose of study medication
  • Currently treated with folic acid at a minimum dose of 5 mg/week
  • have no active or latent tuberculosis
  • should be generally in good health
  • if female, should either be postmenopausal or using an acceptable methods of birth control
  • if male, should be willing to use two forms of birth control concurrently

Exclusion Criteria:

  • have other inflammatory disease other than RA
  • have used any of the following medications -- D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold salts, sulfasalazine, leflunomide, azathioprine, cyclosporine, tacrolimus, and mycophenolate mofetil
  • received IV or injections of corticosteroids with the last 4 weeks
  • have been treated with any other investigational drug or device within the last 4 weeks
  • have undergone any surgical treatments for RA in the last 3 months
  • have undergone a joint biopsy in the last month
  • have had an viral or bacterial vaccine within the last month (eg. FluMist)
  • are positive with HIV or Hepatitis B or C
GenderBoth
Ages18 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:info1@veritasmedicine.com
Location Countries  ICMJECzech Republic,   Ireland,   Korea, Republic of,   Netherlands,   Poland,   Russian Federation,   Spain,   Taiwan,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00941707
Responsible PartyDirector, Clinical Development, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Study ID Numbers  ICMJECR016414
Study Sponsor  ICMJEJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical TrialJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information Provided ByJohnson & Johnson Pharmaceutical Research & Development, L.L.C.