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Objective Study in Rheumatoid Arthritis

NCT00451971 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2008-09-05

No results posted yet for this study

Summary

Primary Objectives

1. To test the feasibility, in patients with active rheumatoid arthritis, of using an 'aggressive' treatment algorithm to bring a short term treatment objective (STO) within the normal or an arbitrarily defined 'desirable' range.
2. To determine whether patients with active rheumatoid arthritis randomly allocated to a particular STO show a reduced rate of Magnetic resonance imaging damage progression at two years compared to those randomly allocated to usual care.

Secondary Objectives

1. To establish the relationship between achieving a given STO or combination of STOs and damage progression.
2. To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

LEFLUNOMIDE

Sponsors & Collaborators

Principal Investigators

  • J Edmonds · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2002-03-31

Countries

  • Australia

Study Locations

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Entities

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 NCT00451971 on ClinicalTrials.gov