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

May 6, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

259

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Ciudad Autónoma De Buenos Aires, Argentina
      • Federal, Argentina
      • Lujan, Argentina
  • Brazil
      • Curitiba, Brazil
      • Porto Alegre, Brazil
      • Sao Paulo, Brazil
  • Czech Republic
      • Brno, Czech Republic
      • Plzeò 1, Czech Republic
      • Praha 1, Czech Republic
      • Praha 2, Czech Republic
      • Uherske Hradiste, Czech Republic
      • Zlin, Czech Republic
  • Germany
      • Bad Abbach, Germany
      • Bad Nauheim, Germany
      • Dresden, Germany
      • Essen, Germany
      • Frankfurt, Germany
      • Herne, Germany
      • Leipzig, Germany
  • Mexico
      • Ciudad De Mexico, Mexico
      • Guadalajara, Mexico
      • Mexico, Mexico
      • San Luis Potosi, Mexico
  • Poland
      • Bialystok, Poland
      • Bydgoszcz, Poland
      • Krakow, Poland
      • Lublin, Poland
      • Poznan, Poland
      • Szczecin, Poland
      • Warszawa, Poland
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Huntsville, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Fair Oaks, California, United States
      • Whittier, California, United States
    • Connecticut
      • Waterbury, Connecticut, United States
    • Florida
      • Sarasota, Florida, United States
    • Illinois
      • Morton Grove, Illinois, United States
      • Springfield, Illinois, United States
    • Maryland
      • Frederick, Maryland, United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo once daily for up to 12 weeks
Experimental: RWJ-445380 100 mg
Drug: RWJ-445380 100 mg
RWJ-445380 100 mg once daily for up to 12 weeks
Experimental: RWJ-445380 200 mg
Drug: RWJ-445380 200 mg
RWJ-445380 200 mg once daily for up to 12 weeks
Experimental: RWJ-445380 300 mg
Drug: RWJ-445380 300 mg
RWJ-445380 300 mg once daily for up to 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks, Explore effectiveness of drug through accepted clinical measures and biomarkers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

January 19, 2007

First Submitted That Met QC Criteria

January 19, 2007

First Posted (Estimate)

January 22, 2007

Study Record Updates

Last Update Posted (Estimate)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR012511
  • C-2006-009 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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