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

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00764725
First received: October 1, 2008
Last updated: December 22, 2008
Last verified: December 2008

October 1, 2008
December 22, 2008
December 2002
April 2007   (final data collection date for primary outcome measure)
EULAR individual response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00764725 on ClinicalTrials.gov Archive Site
All core set variables; function; x-ray; health-economic [ Time Frame: 6-24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: conventional DMARD combination
    MTX+SSZ+Plaquenil; can be changed to MTX+cyclosporin within protocol
    Other Name: MTX=Methotrexate, SSZ=Sulfasalazine, Plaquenil=HCQ
  • Biological: MTX plus anti-TNF
    MTX + infliximab; can be changed to MTX + etanercept within protocol
    Other Name: infliximab=Remicade
  • Active Comparator: A
    MTX+SSZ+Plaquenil
    Intervention: Drug: conventional DMARD combination
  • Active Comparator: B
    MTX+Infliximab
    Intervention: Biological: MTX plus anti-TNF

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
487
December 2008
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • RA, symptom duration < 12 months

Exclusion Criteria:

  • Contraindication to any of the trial medications
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00764725
P0 3013 Swefot
No
Dr. Johan Bratt, Karolinska University Hospital
Karolinska Institutet
Not Provided
Principal Investigator: Johan Bratt, MD PhD Karolinska University Hospital
Karolinska Institutet
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP