Objectives Study in Rheumatoid Arthritis (The OSRA Study)

Rheumatoid synovitis causes largely irreversible damage to cartilage, bone and ligaments. Drug therapy aims to provide symptomatic relief but more importantly to suppress synovitis, or ‘disease activity’, in the hope that this will limit joint damage. Total elimination of disease is a challenging target in any patient and almost unachievable in anyone with established disease.

A more practical aim, applicable to the range of disease severity and duration currently under care, would be the identification of a level of disease ‘activity’ suppression, which would significantly limit damage progression. This notion implies the identification of a disease ‘activity’ surrogate.

Official Title

The Objectives Study in Rheumatoid Arthritis Designed to Test the Value of a Treatment Objective Rather Than a Drug

Conditions

Rheumatoid Arthritis

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• compare the success rates of STOs in achieving normal or specified target range by comparing proportions of patients attaining target
• compare the mean rate of MRI damage progression across three arms using a one-way analysis of variance for a random effects model
• Bonferroni, Sidak and Scheffe multiple-comparison tests will be performed

Secondary Outcome Measures:

• the relationship between achieving a given STO or combination of STOs and damage progression
• identify the characteristics of responders and non-responders with respect to STO achievement and predictors of greater and lesser degree of damage progression

Study Start

May 2002; Study completion: September 2005

Eligibility & Criteria

• Ages Eligible for Study: 18 Years – 75 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• Rheumatoid Arthritis as defined by the ACR criteria and either:
  • Active disease: > or = to 6/28 swollen joints or
  • ESR or CRP > normal or
  • DAS > or = to 3.2
• Age 18 yrs to < or = to 75 yrs except patients may be older than 75 yrs if it is clear that they are physically robust and well
• Disease duration < or = to 15 yrs except patients may have disease duration greater than 15 yrs provided that they do not have end-stage disease or are physically frail because of their disease
• Any therapy
• Females of child-bearing potential must have 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
• Subjects unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

Total Enrolment

250

Contact Details

• Canberra Rheumatology, Canberra, Australian Capital Territory, 2601, Australia
• Rheumatology Dept, St George Hospital, Kogarah, Sydney, New South Wales, 2217, Australia
• Hobart Rheumatology, Hobart, Tasmania, 7004, Australia
• St Vincents Hospital, Melbourne, Victoria, 3065, Australia
• Monash Medical Centre, Melbourne, Victoria, 3168, Australia