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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) (SWEFOT)

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ClinicalTrials.gov Identifier: NCT00764725
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : December 23, 2008
Sponsor:
Information provided by:
Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 2, 2008
Last Update Posted Date December 23, 2008
Study Start Date  ICMJE December 2002
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
EULAR individual response [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
All core set variables; function; x-ray; health-economic [ Time Frame: 6-24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT)
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: A
    MTX+SSZ+Plaquenil
    Intervention: Drug: conventional DMARD combination
  • Active Comparator: B
    MTX+Infliximab
    Intervention: Biological: MTX plus anti-TNF
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2008)
487
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • RA, symptom duration < 12 months

Exclusion Criteria:

  • Contraindication to any of the trial medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764725
Other Study ID Numbers  ICMJE P0 3013 Swefot
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Johan Bratt, Karolinska University Hospital
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Johan Bratt, MD PhD Karolinska University Hospital
PRS Account Karolinska Institutet
Verification Date December 2008

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