Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
RWJ-445380 100 mg
RWJ-445380 200 mg
RWJ-445380 300 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Arthritis, Joints, Auto immune
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
RWJ-445380 100 mg
RWJ-445380 200 mg
RWJ-445380 300 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Explore effectiveness of drug through accepted arthritis clinical measures and biomarkers
Full Information
NCT ID
NCT00425321
First Posted
January 19, 2007
Last Updated
May 6, 2014
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1. Study Identification
Unique Protocol Identification Number
NCT00425321
Brief Title
Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Arthritis, Joints, Auto immune
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
259 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RWJ-445380 100 mg
Arm Type
Experimental
Arm Title
RWJ-445380 200 mg
Arm Type
Experimental
Arm Title
RWJ-445380 300 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
RWJ-445380 100 mg
Intervention Description
RWJ-445380 100 mg once daily for up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
RWJ-445380 200 mg
Intervention Description
RWJ-445380 200 mg once daily for up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
RWJ-445380 300 mg
Intervention Description
RWJ-445380 300 mg once daily for up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily for up to 12 weeks
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Huntsville
State/Province
Alabama
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Fair Oaks
State/Province
California
Country
United States
City
Whittier
State/Province
California
Country
United States
City
Waterbury
State/Province
Connecticut
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Morton Grove
State/Province
Illinois
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
Frederick
State/Province
Maryland
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Buenos Aires
Country
Argentina
City
Ciudad Autónoma De Buenos Aires
Country
Argentina
City
Federal
Country
Argentina
City
Lujan
Country
Argentina
City
Curitiba
Country
Brazil
City
Porto Alegre
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Brno
Country
Czech Republic
City
Plzeò 1
Country
Czech Republic
City
Praha 1
Country
Czech Republic
City
Praha 2
Country
Czech Republic
City
Uherske Hradiste
Country
Czech Republic
City
Zlin
Country
Czech Republic
City
Bad Abbach
Country
Germany
City
Bad Nauheim
Country
Germany
City
Dresden
Country
Germany
City
Essen
Country
Germany
City
Frankfurt
Country
Germany
City
Herne
Country
Germany
City
Leipzig
Country
Germany
City
Ciudad De Mexico
Country
Mexico
City
Guadalajara
Country
Mexico
City
Mexico
Country
Mexico
City
San Luis Potosi
Country
Mexico
City
Bialystok
Country
Poland
City
Bydgoszcz
Country
Poland
City
Krakow
Country
Poland
City
Lublin
Country
Poland
City
Poznan
Country
Poland
City
Szczecin
Country
Poland
City
Warszawa
Country
Poland
12. IPD Sharing Statement
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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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