Condition category
Musculoskeletal Diseases
Date applied
26/02/2010
Date assigned
06/04/2010
Last edited
06/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Inga-Lill Engvall

ORCID ID

Contact details

Department of Rheumatology
R92
Karolinska University Hospital
Huddinge
Stockholm
14186
Sweden

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

http://www.karolinska.se/

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

  1. 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.

Additional files

Editorial Notes