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

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases; Other rheumatoid arthritis

• Registration Number: ISRCTN39045408
• Lead Sponsor: Karolinska University Hospital (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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