Objective Study in Rheumatoid Arthritis (OSRA)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00451971
First received: March 23, 2007
Last updated: September 4, 2008
Last verified: September 2008

March 23, 2007
September 4, 2008
March 2002
Not Provided
  • 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)
Same as current
Complete list of historical versions of study NCT00451971 on ClinicalTrials.gov Archive Site
Safety: Full blood count and erythrocyte sedimentation, blood urea, electrolytes, creatinine and Liver function test
Same as current
Not Provided
Not Provided
 
Objective Study in Rheumatoid Arthritis
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Arthritis, Rheumatoid
Drug: LEFLUNOMIDE
Not Provided
Poh MQ, Lassere M, Bird P, Edmonds J. Reliability and longitudinal validity of computer-assisted methods for measuring joint damage progression in subjects with rheumatoid arthritis. J Rheumatol. 2013 Jan;40(1):23-9. doi: 10.3899/jrheum.120549. Epub 2012 Nov 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
249
Not Provided
Not Provided

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00451971
HWA486_4020
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Principal Investigator: J Edmonds Sanofi
Sanofi
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP