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

Information source: Alza Corporation, DE, USA
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: RWJ-445380 (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Alza Corporation, DE, USA

Official(s) and/or principal investigator(s):
Alza Corporation Clinical Trial, Study Director, Affiliation: Alza Corporation, DE, USA

Overall 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:, Email: info1@veritasmedicine.com

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.

Clinical Details

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Primary outcome: 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: Explore effectiveness of drug through accepted arthritis clinical measures and biomarkers

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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    

Locations and Contacts

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Lujan 6700, Argentina; Active, not recruiting

Capital Federal 1121, Argentina; Active, not recruiting

Capital Federal 14 29, Argentina; Active, not recruiting

San Martín 1650, Argentina; Active, not recruiting

Capital Federal 1221, Argentina; Active, not recruiting

São Paulo 04230-000, Brazil; Active, not recruiting

Sao Paulo 04023, Brazil; Active, not recruiting

São Paulo 01202-000, Brazil; Active, not recruiting

Curitiba 80060-900, Brazil; Active, not recruiting

Porto Alegre 90035-903, Brazil; Active, not recruiting

Campinas 13590-900, Brazil; Active, not recruiting

São Paulo, Brazil; Active, not recruiting

Rio Grande Do Sul, Brazil; Active, not recruiting

São Paulo 05652-900, Brazil; Active, not recruiting

Praha 2 128 50, Czech Republic; Active, not recruiting

Zlin 760 01, Czech Republic; Active, not recruiting

Plzen 305 99, Czech Republic; Recruiting

Brno 65691, Czech Republic; Active, not recruiting

Uherske Hradiste 686 01, Czech Republic; Active, not recruiting

Praha 1 110 00, Czech Republic; Active, not recruiting

Herne 44652, Germany; Active, not recruiting

Frankfurt 60590, Germany; Active, not recruiting

Bad Abbach 93077, Germany; Active, not recruiting

Essen 45239, Germany; Active, not recruiting

Dresden 01307, Germany; Active, not recruiting

Leipzig 04103, Germany; Active, not recruiting

Bad Nauheim 61231, Germany; Recruiting

Guadalajara 44620, Mexico; Active, not recruiting

San Luis Potosí 78240, Mexico; Active, not recruiting

Mexico 06700, Mexico; Active, not recruiting

Mexico City 03100, Mexico; Active, not recruiting

Guadalajara 44650, Mexico; Active, not recruiting

Warszawa 02 - 637, Poland; Active, not recruiting

Bydgoszcz 85-165, Poland; Active, not recruiting

Lublin 20-022, Poland; Active, not recruiting

Krakow 30-510, Poland; Active, not recruiting

Szczecin, Poland; Active, not recruiting

Bialystok 15-950, Poland; Active, not recruiting

Warszawa 02-777, Poland; Active, not recruiting

Poznan 60-218, Poland; Active, not recruiting

Birmingham, Alabama 35294, United States; Active, not recruiting

Huntsville, Alabama 35801, United States; Active, not recruiting

Tucson, Arizona 85737, United States; Active, not recruiting

Fair Oaks, California 95628, United States; Active, not recruiting

Whittier, California 90601, United States; Active, not recruiting

Colorado Springs, Colorado 80910, United States; Recruiting

Waterbury, Connecticut 06708, United States; Active, not recruiting

Sarasota, Florida 34239, United States; Active, not recruiting

Morton Grove, Illinois 60053, United States; Active, not recruiting

Springfield, Illinois 62704, United States; Active, not recruiting

Frederick, Maryland 21702, United States; Recruiting

Duncansville, Pennsylvania 16635, United States; Active, not recruiting

Nashville, Tennessee 37203, United States; Active, not recruiting

Austin, Texas 78704, United States; Active, not recruiting

Additional Information

For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Additional information is provided at the following link;http://dailymed.nlm.nih.gov/dailymed/about.cfm

For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm

To learn how to participate in this trial please click here.

Starting date: November 2006
Last updated: November 29, 2007

Page last updated: December 31, 2007

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