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A Study to Assess CH1504 in Patients With Active Rheumatoid Arthritis

NCT00658047 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2013-04-15

No results posted yet for this study

Summary

The purpose of this trial is to assess the clinical effect of CH-1504 at doses of 0.25, 0.5 and 1.0 mg per day in patients with active rheumatoid arthritis by determining the proportion of patients achieving an American College of Rheumatology (ACR) 20% improvement response.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

CH-1504

Comparison of different doses of CH-1504

DRUG

Methotrexate (MTX)

10mg/week for 2 weeks escalated to 15mg/week for 2 weeks escalated to 20mg/week for 8 weeks

Sponsors & Collaborators

  • Chelsea Therapeutics

    lead INDUSTRY

Principal Investigators

  • Edward Keystone, MD · The Rebecca MacDonald Centre for Arthritis and Autoimmune Disease

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-02-28
Completion
2009-06-30

Countries

  • Canada

Study Locations

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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 NCT00658047 on ClinicalTrials.gov