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

NCT00425321 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 259

Last updated 2014-05-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

RWJ-445380 300 mg

RWJ-445380 300 mg once daily for up to 12 weeks

DRUG

Placebo

Placebo once daily for up to 12 weeks

DRUG

RWJ-445380 100 mg

RWJ-445380 100 mg once daily for up to 12 weeks

DRUG

RWJ-445380 200 mg

RWJ-445380 200 mg once daily for up to 12 weeks

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States
  • Argentina
  • Brazil
  • Czechia
  • Germany
  • Mexico
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00425321 on ClinicalTrials.gov