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A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy

NCT00316771 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2016-11-02

No results posted yet for this study

Summary

This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75 bid po) or placebo, and will remain on the stable dose of 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) 150mg

150mg po qd

DRUG

P38 Inhibitor (4) 25mg

25mg po bid

DRUG

P38 Inhibitor (4) 300mg

300mg po qd

DRUG

P38 Inhibitor (4) 50mg

50mg po qd

DRUG

P38 Inhibitor (4) 75mg

75mg po bid

DRUG

Placebo

po bid

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
2005-11-30
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Estonia
  • Germany
  • Greece
  • Ireland
  • Mexico
  • New Zealand
  • Poland
  • South Africa
  • Spain
  • United Kingdom

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 NCT00316771 on ClinicalTrials.gov