OSRA: Objective Study in Rheumatoid Arthritis

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00451971
• Collaborator: (none)
• Enrollment: 249
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid	Drug: LEFLUNOMIDE	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 249 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Objective Study in Rheumatoid Arthritis
• Study Start Date: Mar 1, 2002

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Sydney		Australia

Sponsors and Collaborators

• Sanofi

Investigators

• Principal Investigator: J Edmonds, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00451971
• Other Study ID Numbers: HWA486_4020; NCT00251667
• First Posted: Mar 26, 2007
• Last Update Posted: Sep 5, 2008
• Last Verified: Sep 1, 2008

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Leflunomide

Study Results

No Results Posted as of Sep 5, 2008