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Objective Study in Rheumatoid Arthritis (OSRA)

Primary Purpose

Arthritis, Rheumatoid

Status

Completed

Phase

Phase 4

Locations

Australia

Study Type

Interventional

Intervention

LEFLUNOMIDE

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis

Outcomes

Primary Outcome Measures

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

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

Full Information

NCT ID

NCT00451971

First Posted

March 23, 2007

Last Updated

September 4, 2008

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00451971

Brief Title

Objective Study in Rheumatoid Arthritis

Acronym

OSRA

Official Title

Objective Study in Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

March 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

Brief Summary

Primary Objectives 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. 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 To establish the relationship between achieving a given STO or combination of STOs and damage progression. To identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degrees of damage progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Single

Allocation

Randomized

Enrollment

249 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

LEFLUNOMIDE

Primary Outcome Measure Information:

Title

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

Title

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

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J Edmonds

Organizational Affiliation

Sanofi

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanofi-Aventis

City

Sydney

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

23118111

Citation

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.

Results Reference

derived

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Objective Study in Rheumatoid Arthritis

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