Official Title: “A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTX”

The Swefot trial was designed to compare two treatment strategies for patients with early rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of traditional antirheumatic medications (DMARDs), versus a combination including a newer "biological" anti-TNF medication. In order to make this trial consistent with current practices in rheumatology, all patients were first given the most commonly used antirheumatic medication, methotrexate (MTX). After 3-4 months those patients who had not responded adequately to this treatment were randomized to receive either MTX plus sulfasalazine plus hydroxychloroquine, or MTX plus infliximab. Again, to be truly life-like, the trial allowed patients who could not tolerate one of the added medications to switch in treatment - but keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be replaced by cyclosporin A, and infliximab by etanercept. The primary outcome in this trial was the percentage of patients who, after one year of treatment, achieved a "good response" as defined by Eular.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2007

The Swefot trial was designed to compare two treatment strategies for patients with early rheumatoid arthritis (less than 1 year symptom duration): the use of a combination of traditional antirheumatic medications (DMARDs), versus a combination including a newer "biological" anti-TNF medication. In order to make this trial consistent with current practices in rheumatology, all patients were first given the most commonly used antirheumatic medication, methotrexate (MTX). After 3-4 months those patients who had not responded adequately to this treatment were randomized to receive either MTX plus sulfasalazine plus hydroxychloroquine, or MTX plus infliximab. Again, to be truly life-like, the trial allowed patients who could not tolerate one of the added medications to switch in treatment - but keeping with the same strategy - so that sulfasalazine plus hydroxychloroquine could be replaced by cyclosporin A, and infliximab by etanercept. The primary outcome in this trial was the percentage of patients who, after one year of treatment, achieved a "good response" as defined by Eular.

Intervention(s) in this Clinical Trial

• Drug: conventional DMARD combination
  • MTX+SSZ+Plaquenil; can be changed to MTX+cyclosporin within protocol
• Biological: MTX plus anti-TNF
  • MTX + infliximab; can be changed to MTX + etanercept within protocol

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • MTX+SSZ+Plaquenil
• Active Comparator: B
  • MTX+Infliximab

Primary Measures

• EULAR individual response
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• All core set variables; function; x-ray; health-economic
  • Time Frame: 6-24 months
    Safety Issue?: No

Inclusion Criteria:

• RA, symptom duration < 12 months

Exclusion Criteria:

• Contraindication to any of the trial medications

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Karolinska Institutet

Overall Clinical Trial Officials and Contacts

Johan Bratt, MD PhD Principal Investigator Karolinska University Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00764725

Study ID Number: P0 3013 Swefot

ClinicalTrials.gov Identifier: NCT00764725

Health Authority: Sweden: Medical Products Agency