Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: conventional DMARD combination Biological: MTX plus anti-TNF |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- EULAR individual response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- All core set variables; function; x-ray; health-economic [ Time Frame: 6-24 months ] [ Designated as safety issue: No ]
| Enrollment: | 487 |
| Study Start Date: | December 2002 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
MTX+SSZ+Plaquenil
|
Drug: conventional DMARD combination
MTX+SSZ+Plaquenil; can be changed to MTX+cyclosporin within protocol
Other Name: MTX=Methotrexate, SSZ=Sulfasalazine, Plaquenil=HCQ
|
|
Active Comparator: B
MTX+Infliximab
|
Biological: MTX plus anti-TNF
MTX + infliximab; can be changed to MTX + etanercept within protocol
Other Name: infliximab=Remicade
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- RA, symptom duration < 12 months
Exclusion Criteria:
- Contraindication to any of the trial medications
Contacts and Locations More Information
No publications provided by Karolinska Institutet
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Johan Bratt, Karolinska University Hospital |
| ClinicalTrials.gov Identifier: | NCT00764725 History of Changes |
| Other Study ID Numbers: | P0 3013 Swefot |
| Study First Received: | October 1, 2008 |
| Last Updated: | December 22, 2008 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Hydroxychloroquine Infliximab Sulfasalazine Antirheumatic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Therapeutic Uses Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Gastrointestinal Agents Central Nervous System Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013