Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT)
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: April 2007
Detailed Clinical Trial Description
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.
Secondary outcomes include Eular and ACR responses, HAQ and other QOL assessments, radiographic outcomes, and health-economic outcomes including EQ5D.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
Outcome Measures for this Clinical Trial
Primary Measures
- EULAR individual response
- Time Frame: 12 months
Safety Issue?: No
- Time Frame: 12 months
Secondary Measures
- All core set variables; function; x-ray; health-economic
- Time Frame: 6-24 months
Safety Issue?: No
- Time Frame: 6-24 months
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Karolinska Institutet Other
Overall Clinical Trial Officials and Contacts
Johan Bratt, MD PhD Principal Investigator Karolinska University Hospital
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00764725
