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NCT00425321 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed
Registry status
Phase 2
Development phase
259
Enrollment target

NCT00425321 is a Phase 2 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 259 participants.

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The verdict

NCT00425321, a Phase 2 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

COMPLETED
Registry status
Phase 2
Development phase
259 participants
Enrollment target

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.

Interventions

  • DRUG Placebo
  • DRUG RWJ-445380 100 mg
  • DRUG RWJ-445380 200 mg
  • DRUG RWJ-445380 300 mg

Trial Details

FieldValue
Enrollment Target 259 participants
Start Date 2006-12
Est. Completion 2008-01
Phase Phase 2

What the Registry Record Tells You About NCT00425321

The ClinicalTrials.gov registry entry for NCT00425321 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 259 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00425321 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00425321 about?

NCT00425321 is a clinical study titled "Safety and Effectiveness 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.

What is the current status of trial NCT00425321?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 259 participants. The study started on 2006-12. Estimated completion is 2008-01.

What interventions are being tested in trial NCT00425321?

The interventions under investigation include: Placebo (DRUG), RWJ-445380 100 mg (DRUG), RWJ-445380 200 mg (DRUG), RWJ-445380 300 mg (DRUG).

Who is sponsoring clinical trial NCT00425321?

This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.