Objective Study in Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

— OSRA  

Official title:

Objective Study in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451971
• Other study ID #: HWA486_4020
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2007
• Last updated: September 4, 2008
• Start date: March 2002

Study information

• Verified date: September 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00251667

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• LEFLUNOMIDE

Locations

Country	Name	City	State
Australia	Sanofi-Aventis	Sydney

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long Term Objective (damage) is the MRI which will be undertaken at baseline, 12 months and 24 months.
Primary	The Short Term Objectives are: swollen joint count - target:(28) = 2 joints
Primary	C-Reactive Protein - target: within the normal range (provided elevation is not due clinically to an intercurrent event)
Secondary	Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test