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 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Open randomised controlled parallel study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (Swedish only) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Methotrexate, sulphasalazine, hydroxychloroquine, infliximab |
| Primary outcome measure | 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 | Changes in serum levels of the adipokines adiponectin and leptin determined by radio immunoassay at randomisation and after 12 and 24 months. |
| Overall study start date | 29/03/2004 |
| Completion date | 13/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 patients |
| 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
Sponsor information
Karolinska University Hospital (Sweden)
Hospital/treatment centre
Hospital/treatment centre
c/o Johan Bratt
Department of Rheumatology R92
Huddinge
Stockholm
14186
Sweden
| Website | http://www.karolinska.se/ |
|---|---|
"ROR" |
https://ror.org/00m8d6786 |
Funders
Funder type
Charity
The Swedish Rheumatism Association (Sweden)
No information available
King Gustav V 80 year's Foundation (Sweden)
No information available
Family Erling-Persson Foundation (Sweden)
No information available
Swedish Research Council (Sweden)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Swedish Research Council, VR
- Location
- Sweden
The Regional Agreement on Medical Training and Clinical Research (ALF) between Stockholm County Council and the Karolinska Institutet (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
