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Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT)

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT00764725
Collaborator
(none)
487
Enrollment
2
Arms
72
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: conventional DMARD combination
  • Biological: MTX plus anti-TNF
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
487 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Dec 1, 2002
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A

MTX+SSZ+Plaquenil

Drug: conventional DMARD combination
MTX+SSZ+Plaquenil; can be changed to MTX+cyclosporin within protocol
Other Names:
  • 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 Names:
  • infliximab=Remicade

    		•

    Outcome Measures

    Primary Outcome Measures

    1. EULAR individual response [12 months]

    Secondary Outcome Measures

    1. All core set variables; function; x-ray; health-economic [6-24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • RA, symptom duration < 12 months
    Exclusion Criteria:
    • Contraindication to any of the trial medications

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Karolinska Institutet

    Investigators

    • Principal Investigator: Johan Bratt, MD PhD, Karolinska University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00764725
    Other Study ID Numbers:
    • P0 3013 Swefot
    First Posted:
    Oct 2, 2008
    Last Update Posted:
    Dec 23, 2008
    Last Verified:
    Dec 1, 2008
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Sulfasalazine
    Methotrexate
    Infliximab

    Study Results

    No Results Posted as of Dec 23, 2008