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Anti-tumour necrosis factor (anti-TNF) therapy over two years increases body fat mass in early rheumatoid arthritis
ISRCTN ISRCTN39045408
DOI 10.1186/ISRCTN39045408
ClinicalTrials.gov identifier
EudraCT number
Public title Anti-tumour necrosis factor (anti-TNF) therapy over two years increases body fat mass in early rheumatoid arthritis
Scientific title 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
Acronym N/A
Serial number at source N/A
Study hypothesis The purpose of this study was to evaluate if anti-tumour necrosis factor alpha (TNF) treatment in early rheumatoid arthritis (RA) had an impact on body composition and bone mineral density (BMD) beyond the anti-inflammatory effects and besides those that could be achieved by intensive disease-modifying anti-rheumatic drugs (DMARD) combination therapy with addition of sulfasalazine and hydroxychloroquine.
Lay summary
Ethics approval Karolinska University Hospital Ethics Committee approved on the 7th April 2004 (ref: 04-088/3)
Study design Open randomised controlled parallel study
Countries of recruitment Sweden
Disease/condition/study domain Rheumatoid arthritis
Participants - 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
Participants - exclusion criteria 1. Prior DMARD therapy
2. Contraindication to any of the trial medications
Anticipated start date 29/03/2004
Anticipated end date 13/12/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet (Swedish only)
Target number of participants 40 patients
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
Treatment B: methotrexate with the addition of the TNF antagonist infliximab, 3 mg/kg body weight given intravenously at weeks 0, 2, 6 and every 8 weeks thereafter

The total duration of treatment and follow-up in this study is two years.
Primary outcome measure(s) 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 measure(s) Changes in serum levels of the adipokines adiponectin and leptin determined by radio immunoassay at randomisation and after 12 and 24 months.
Sources of funding 1. The Swedish Rheumatism Association (Sweden)
2. King Gustav V 80 year's Foundation (Sweden)
3. Family Erling-Persson Foundation (Sweden)
4. Swedish Research Council (Sweden)
5. The Regional Agreement on Medical Training and Clinical Research (ALF) between Stockholm County Council and the Karolinska Institutet (Sweden)
Trial website
Publications 1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20964833
Contact name Dr  Inga-Lill  Engvall
  Address Department of Rheumatology, R92
Karolinska University Hospital
Huddinge
  City/town Stockholm
  Zip/Postcode 14186
  Country Sweden
Sponsor Karolinska University Hospital (Sweden)
  Address c/o Johan Bratt
Department of Rheumatology R92
Huddinge
  City/town Stockholm
  Zip/Postcode 14186
  Country Sweden
  Sponsor website: http://www.karolinska.se/
Date applied 26/02/2010
Last edited 06/04/2011
Date ISRCTN assigned 06/04/2010
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