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

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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT00425321 record still lists

NCT00425321 is an interventional study that assigns participants to a tested intervention. The registered 259 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher).

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

NCT00425321 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00425321's enrollment target sits among peer trials

259 212th of 2000 higher than 1,789 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00425321, the US trial registry maintained by the National Library of Medicine. NCT00425321 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.