Skip to main content
OpenTrials
Completed

NCT Number: NCT00451971

Objective Study in Rheumatoid Arthritis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Sydney, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rheumatoid Arthritis as defined by the American College of Rhemuatology criteria and either
  • Active disease: ≥6/28 swollen joints or
  • Erythrocyte sedimantation or C-Reactive Protein > normal
  • Disease duration ≤ 15 yrs
  • Any therapy
  • Females of child-bearing potential must be adequate contraception

Exclusion criteria

  • Frailty, limiting co-morbidity
  • Obesity limiting ability to have MRI
  • Geographical difficulty preventing follow-up and visits
  • Women at risk of becoming pregnant

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

leflunomide

Drug

Primary outcomes

  1. Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.

  2. The Short Term Objectives are: swollen joint count - target:(28) ≤ 2 joints

  3. C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event)

Secondary outcomes

  1. Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Acronym: OSRA

Important dates

Study start
2002
First posted
Mar 26, 2007
Registry last updated
Sep 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.