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Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00425321
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE January 19, 2007
First Posted Date  ICMJE January 22, 2007
Last Update Posted Date May 21, 2014
Study Start Date  ICMJE December 2006
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2009)
Evaluate the safety of RWJ-445380 for up to 12 weeks; assessing adverse events, vital signs, laboratory and physical exam and ECGs in patients with rheumatoid arthritis [ Time Frame: up to 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2007)
Evaluate the safety of RWJ-445380 for up to 12 weeks; assessing adverse events, vital signs, laboratory and physical exam and ECGs in patients with rheumatoid arthritis
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2009)
Explore effectiveness of drug through accepted arthritis clinical measures and biomarkers [ Time Frame: 12 weeks, Explore effectiveness of drug through accepted clinical measures and biomarkers ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2007)
Explore effectiveness of drug through accepted arthritis clinical measures and biomarkers
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Official Title  ICMJE A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Brief Summary The primary objective of the study is to evaluate the safety and tolerability of 100, 200, and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with active Rheumatoid Arthritis despite methotrexate therapy.
Detailed Description Trials with a new, first -in-class drug will be done to ascertain safety, tolerability, and to explore efficacy in the treatment of rheumatoid arthritis, including its effects on biomarkers. Approximately 240 adult patients with rheumatoid arthritis despite the use of methotrexate therapy will be recruited for the study. They will be randomly assigned to one of 4 treatment arms; each patient has an equal chance of receiving the placebo, or 100 mg, 200 mg, 300 mg dose of RWJ-445380. Patients will take the medication daily for up to 12 weeks. Patients will receive study medication in a blinded fashion, i.e. the patient, the doctor and the study sponsor will not know what group the patient is in until all patients complete the study. The investigator and the sponsor will monitor the study for the occurrence of possible side effects. In addition to a screening visit, patients will have visits every week for the first 2 weeks then every 2 weeks until 12 weeks of treatment. After 12 weeks, there will be a followup visit 4 weeks after the last dose of study drug is taken. Medical history, physical examination, blood pressure, heart rate, temperature, and ECGs are checked periodically. Joints will be assessed to explore whether the drug might affect tender and swollen joints. Blood samples will be taken for standard safety laboratory tests as well as special tests of the drug blood level, biomarkers to see whether the drug might be affecting the biological pathway of antigen presentation, and other markers for rheumatoid arthritis. Samples will also be taken to see whether certain types of immune cells are affected by taking the drug. Immunization with tetanus vaccine will be done to see if taking the drug might affect immune responses to this agent Patients will receive RWJ-445380, 100, 200, 300 mg, or placebo. Patients will receive oral capsules daily for up to 12 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: RWJ-445380 100 mg
    RWJ-445380 100 mg once daily for up to 12 weeks
  • Drug: RWJ-445380 200 mg
    RWJ-445380 200 mg once daily for up to 12 weeks
  • Drug: RWJ-445380 300 mg
    RWJ-445380 300 mg once daily for up to 12 weeks
  • Drug: Placebo
    Placebo once daily for up to 12 weeks
Study Arms  ICMJE
  • Experimental: RWJ-445380 100 mg
    Intervention: Drug: RWJ-445380 100 mg
  • Experimental: RWJ-445380 200 mg
    Intervention: Drug: RWJ-445380 200 mg
  • Experimental: RWJ-445380 300 mg
    Intervention: Drug: RWJ-445380 300 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2009)
259
Original Enrollment  ICMJE
 (submitted: January 19, 2007)
240
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients diagnosed with rheumatoid arthritis for at least 6 months with at least 8 tender and 8 swollen joints
  • methotrexate treatment for 6 months
  • at least 10mg/wk and stable dose for at least 8 weeks
  • negative TB screening

Exclusion Criteria:

  • Use of other disease-modifying anti-rheumatic drugs (DMARDs) (other than Methotrexate MTX)
  • previous use of more than 1 anti-TNF (tumor necrosis factor) agent
  • previous use of cytotoxics, p38 MAPkinase inhibitor, anti-CD4 antibody
  • receipt of live vaccine within 1 month of study drug
  • serious infection in previous 2 months or history of chronic or recurrent infectious disease or history of opportunistic infection
  • other clinically significant disease of other organ system
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Czech Republic,   Germany,   Mexico,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00425321
Other Study ID Numbers  ICMJE CR012511
C-2006-009 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP