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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00425321 |
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Date of registration:
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19/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
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Scientific title:
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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 |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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259 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00425321 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Brazil
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Czech Republic
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Germany
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Mexico
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Poland
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United States
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Contacts
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Name:
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: RWJ-445380 200 mg
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Drug: RWJ-445380 100 mg
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Drug: Placebo
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Drug: RWJ-445380 300 mg
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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C-2006-009
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CR012511
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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