Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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.
Ethics approval
Karolinska University Hospital Ethics Committee approved on the 7th April 2004 (ref: 04-088/3)
Study design
Open randomised controlled parallel study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet (Swedish only)
Condition
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 names
Methotrexate, sulphasalazine, hydroxychloroquine, infliximab
Primary outcome measures
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 trial start date
29/03/2004
Overall trial end date
13/12/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 patients
Participant exclusion criteria
1. Prior DMARD therapy
2. Contraindication to any of the trial medications
Recruitment start date
29/03/2004
Recruitment end date
13/12/2007
Locations
Countries of recruitment
Sweden
Trial participating centre
Department of Rheumatology, R92
Stockholm
14186
Sweden
Sponsor information
Organisation
Karolinska University Hospital (Sweden)
Sponsor details
c/o Johan Bratt
Department of Rheumatology R92
Huddinge
Stockholm
14186
Sweden
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
The Swedish Rheumatism Association (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
King Gustav V 80 year's Foundation (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Family Erling-Persson Foundation (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Swedish Research Council (Sweden)
Alternative name(s)
Swedish Research Council, VR
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Sweden
Funder name
The Regional Agreement on Medical Training and Clinical Research (ALF) between Stockholm County Council and the Karolinska Institutet (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20964833
Publication citations
-
Results
Engvall IL, Tengstrand B, Brismar K, Hafström I, Infliximab 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 21 months., Arthritis Res. Ther., 2010, 12, 5, R197, doi: 10.1186/ar3169.