Objective Study in Rheumatoid Arthritis (OSRA)

September 4, 2008 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

249

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.
The Short Term Objectives are: swollen joint count - target:(28) ≤ 2 joints
C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event)

Secondary Outcome Measures

Outcome Measure
Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Principal Investigator: J Edmonds, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

March 23, 2007

First Submitted That Met QC Criteria

March 23, 2007

First Posted (Estimate)

March 26, 2007

Study Record Updates

Last Update Posted (Estimate)

September 5, 2008

Last Update Submitted That Met QC Criteria

September 4, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HWA486_4020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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