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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 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.

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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

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT00303563

The ClinicalTrials.gov registry entry for NCT00303563 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (96% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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

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.