A Phase 4 interventional study of conventional DMARD combination and MTX plus anti-TNF in Rheumatoid Arthritis, sponsored by Karolinska Institutet. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-12-23.
Sponsored by Karolinska Institutet · Phase 4, Interventional, and Treatment
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.
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 487 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
MTX+SSZ+Plaquenil
Drug: conventional DMARD combination
MTX+Infliximab
Biological: MTX plus anti-TNF
MTX+SSZ+Plaquenil; can be changed to MTX+cyclosporin within protocol
Also known as: MTX=Methotrexate, SSZ=Sulfasalazine, Plaquenil=HCQ
MTX + infliximab; can be changed to MTX + etanercept within protocol
Also known as: infliximab=Remicade
EULAR individual response
Time frame: 12 months
All core set variables; function; x-ray; health-economic
Time frame: 6-24 months
No study locations are listed for this record.
This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet