Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
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
2 other identifiers
interventional
259
7 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Dec 2006
Shorter than P25 for phase_2 rheumatoid-arthritis
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 19, 2007
CompletedFirst Posted
Study publicly available on registry
January 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedMay 21, 2014
May 1, 2014
1.1 years
January 19, 2007
May 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
up to 12 weeks
Secondary Outcomes (1)
Explore effectiveness of drug through accepted arthritis clinical measures and biomarkers
12 weeks, Explore effectiveness of drug through accepted clinical measures and biomarkers
Study Arms (4)
RWJ-445380 100 mg
EXPERIMENTALRWJ-445380 200 mg
EXPERIMENTALRWJ-445380 300 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Huntsville, Alabama, United States
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Tucson, Arizona, United States
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Fair Oaks, California, United States
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Whittier, California, United States
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Waterbury, Connecticut, United States
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Sarasota, Florida, United States
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Morton Grove, Illinois, United States
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Springfield, Illinois, United States
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Frederick, Maryland, United States
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Duncansville, Pennsylvania, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Buenos Aires, Argentina
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Federal, Argentina
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Luján, Argentina
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Curitiba, Brazil
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Porto Alegre, Brazil
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São Paulo, Brazil
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Brno, Czechia
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Plzeò 1, Czechia
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Prague, Czechia
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Uherské Hradiště, Czechia
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Zlín, Czechia
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Bad Abbach, Germany
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Bad Nauheim, Germany
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Dresden, Germany
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Essen, Germany
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Frankfurt, Germany
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Herne, Germany
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Leipzig, Germany
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Guadalajara, Mexico
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Mexico City, Mexico
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México, Mexico
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San Luis Potosí City, Mexico
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Bialystok, Poland
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Bydgoszcz, Poland
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Krakow, Poland
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Lublin, Poland
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Poznan, Poland
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Szczecin, Poland
Unknown Facility
Warsaw, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2007
First Posted
January 22, 2007
Study Start
December 1, 2006
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
May 21, 2014
Record last verified: 2014-05