Anti-tumour necrosis factor (anti-TNF) therapy over two years increases body fat mass in early rheumatoid arthritis
| ISRCTN | ISRCTN39045408 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39045408 |
| Protocol serial number | N/A |
| Sponsor | Karolinska University Hospital (Sweden) |
| Funders | The Swedish Rheumatism Association (Sweden), King Gustav V 80 year's Foundation (Sweden), Family Erling-Persson Foundation (Sweden), Swedish Research Council (Sweden), The Regional Agreement on Medical Training and Clinical Research (ALF) between Stockholm County Council and the Karolinska Institutet (Sweden) |
- Submission date
- 26/02/2010
- Registration date
- 06/04/2010
- Last edited
- 06/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Inga-Lill Engvall
Scientific
Scientific
Department of Rheumatology, R92
Karolinska University Hospital
Huddinge
Stockholm
14186
Sweden
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open randomised controlled parallel study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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. |
| Ethics approval(s) | Karolinska University Hospital Ethics Committee approved on the 7th April 2004 (ref: 04-088/3) |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Methotrexate, sulphasalazine, hydroxychloroquine, infliximab |
| 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. |
| Key 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. |
| Completion date | 13/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key 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 |
| Key exclusion criteria | 1. Prior DMARD therapy 2. Contraindication to any of the trial medications |
| Date of first enrolment | 29/03/2004 |
| Date of final enrolment | 13/12/2007 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Rheumatology, R92
Stockholm
14186
Sweden
14186
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
