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Objective Study in Rheumatoid Arthritis

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis, Rheumatoid

Intervention: LEFLUNOMIDE (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
J Edmonds, Principal Investigator, Affiliation: Sanofi

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.

Clinical Details

Official title: Objective Study in Rheumatoid Arthritis

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

Primary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

Sanofi-Aventis, Sydney, Australia
Additional Information

Starting date: March 2002
Last updated: September 4, 2008

Page last updated: August 20, 2015

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