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Effects of addition of low-dose oral daily corticosteroids to the initial anti-rheumatic therapy on radiographic damage and disease activity in patients with early rheumatoid arthritis

Effects of addition of low-dose oral daily prednisolone to the initial disease-modifying anti-rheumatic drugs (DMARD) therapy on progression of radiographic damage and disease activity in patients with early rheumatoid arthritis, as well as effects on adverse outcomes and toxicity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN20612367
Enrollment
250
Registered
2014-02-04
Start date
1995-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis Musculoskeletal Diseases Rheumatoid arthritis, unspecified

Interventions

The patients were recruited from the 6 centres involved in the BARFOT (Better Anti-Rheumatic FarmacOTherapy) Study Group in southern Sweden. The randomization was done as block randomization for each

Sponsors

Karolinska Institute (Karolinska Institutet) (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of RA according to the 1987 revised criteria of the American College of Rheumatology (ACR) 2. Age 18-80 years 3. Disease duration of = 1 year 4. Active disease defined as a Disease Activity Score in 28 joints (DAS28) of >3.0 5. Started by the treating rheumatologist on the first DMARD

Exclusion criteria

Exclusion criteria: 1. Earlier treatment with glucocorticoids for RA or other diseases 2. Previous treatment with DMARDs 3. Contraindication for glucocorticoid therapy 4. Previous fragility fractures 5. Patients aged < 65 years with a T-score lower than -2.5 on bone densitometry; and patients aged = 65 years with a Z-score of less than -1

Design outcomes

Primary

MeasureTime frame
The difference in changes in radiographic damage scores after 2 years Timepoint(s): Pre- and post-intervention. Clinical assessment at the start of the study and at 3, 6, 12, 18, and 24 months. Radiographic evaluation at baseline and after 1 and 2 years

Secondary

MeasureTime frame
1. Remission rates and differences in disease activity and function 2. Adverse events

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026