Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00303563 · ClinicalTrials.gov registry record · Phase 2

A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis

A Phase 2 study of Rheumatoid Arthritis, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
204
Enrollment target
20
Study locations

NCT00303563: Completed Phase 2 study of Rheumatoid Arthritis, sponsored by Hoffmann-La Roche.

NCT00303563 is a Phase 2 study of Rheumatoid Arthritis that has completed, run by Hoffmann-La Roche. The registered enrollment target is 204 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00303563, a Phase 2 study of Rheumatoid Arthritis, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
204 participants
Enrollment target
20
Study locations

Study Summary

This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Conditions Studied

Rheumatoid Arthritis

Interventions

  • DRUG Placebo
  • DRUG P38 Inhibitor (4)

Study Locations (20)

Arizona

  • - Scottsdale
  • - Tucson
  • - Tucson

Tennessee

  • - Knoxville
  • - Memphis
  • - Nashville

California

  • - Escondido
  • - Loma Linda

Pennsylvania

  • - Danville
  • - Lancaster

Alabama

  • - Anniston

Connecticut

  • - Stamford

Illinois

  • - Morton Grove

Indiana

  • - South Bend

Trial Details

FieldValue
Enrollment Target 204 participants
Start Date 2006-04
Est. Completion 2007-12
Phase Phase 2
Hoffmann-La Roche

909 total trials

What the finished NCT00303563 record still lists

NCT00303563 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00303563 names 20 study sites across 14 states, led by Arizona, Tennessee, California.

Frequently Asked Questions

What is clinical trial NCT00303563 about?

NCT00303563 is a clinical study titled "A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis". This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses o...

What is the current status of trial NCT00303563?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 204 participants. The study started on 2006-04. Estimated completion is 2007-12.

What conditions does trial NCT00303563 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis.

What interventions are being tested in trial NCT00303563?

The interventions under investigation include: Placebo (DRUG), P38 Inhibitor (4) (DRUG).

Who is sponsoring clinical trial NCT00303563?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00303563 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Rheumatoid Arthritis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00303563's enrollment target sits among peer trials

204 82nd of 197 higher than 116 of 197 other Rheumatoid Arthritis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Rheumatoid Arthritis 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03481010 · 204 participants · NA

    Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology

  • NCT04249830 · 204 participants · NA

    Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults

  • NCT04503395 · 204 participants · NA

    ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

  • NCT04793776 · 204 participants · NA

    Manage Emotions to Reduce Aggression (MERA)

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Related registry views

Source: ClinicalTrials.gov NCT00303563, the US trial registry maintained by the National Library of Medicine. NCT00303563 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.