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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

Study Description
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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
Rheumatoid Arthritis 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
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Study Type : Interventional  (Clinical Trial)
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 : December 2002
Actual Primary Completion Date : April 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. EULAR individual response [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. All core set variables; function; x-ray; health-economic [ Time Frame: 6-24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • RA, symptom duration < 12 months

Exclusion Criteria:

  • Contraindication to any of the trial medications
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764725


Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Johan Bratt, MD PhD Karolinska University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Johan Bratt, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT00764725    
Other Study ID Numbers: P0 3013 Swefot
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: December 23, 2008
Last Verified: December 2008
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Sulfasalazine
Methotrexate
Infliximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Gastrointestinal Agents
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic