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Anti-tumour necrosis factor (anti-TNF) therapy over two years increases body fat mass in early rheumatoid arthritis

Anti-tumour necrosis factor therapy increases body fat mass in early rheumatoid arthritis independently of changes in disease activity and levels of leptin and adiponectin: a randomised study over two years

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39045408
Enrollment
40
Registered
2010-04-06
Start date
2004-03-29
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 Other rheumatoid arthritis

Interventions

After 3 months the patients who had not achieved low disease activity were randomised: Treatment A: methotrexate with addition of sulphasalazine, 2000 mg/day, and hydroxychloroquine, 400 mg daily Trea

Sponsors

Karolinska University Hospital (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with early RA (disease duration less than 12 months) 2. Participated in the Swefot (SWEdish PHarmacOTherapy) study at Karolinska University Hospital at Huddinge 3. Patients started treatment with methotrexate 4. Active disease defined as a Disease Activity Score of 28 joints (DAS28) above 3.2 5. Aged between 18 and 80 years, either sex

Exclusion criteria

Exclusion criteria: 1. Prior DMARD therapy 2. Contraindication to any of the trial medications

Design outcomes

Primary

MeasureTime frame
Effects of anti-TNF treatment on body composition and BMD beyond the anti-inflammatory effect. Assessed by dual X-ray absortiometry for total body, lumbar spine and femoral neck at the time of randomisation and after 12 and 24 months.

Secondary

MeasureTime frame
Changes in serum levels of the adipokines adiponectin and leptin determined by radio immunoassay at randomisation and after 12 and 24 months.

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026