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

NCT00303563 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2016-11-02

No results posted yet for this 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

Interventions

DRUG

P38 Inhibitor (4)

50mg po qd

DRUG

P38 Inhibitor (4)

150mg po qd

DRUG

P38 Inhibitor (4)

300mg po qd

DRUG

Placebo

po qd

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States
  • Canada
  • Croatia
  • Czechia
  • France
  • Italy
  • Mexico
  • Romania
  • Serbia
  • South Africa
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00303563 on ClinicalTrials.gov