Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT) (SWEFOT)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
conventional DMARD combination
MTX plus anti-TNF
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- RA, symptom duration < 12 months
Exclusion Criteria:
- Contraindication to any of the trial medications
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
MTX+SSZ+Plaquenil
MTX+Infliximab
Outcomes
Primary Outcome Measures
EULAR individual response
Secondary Outcome Measures
All core set variables; function; x-ray; health-economic
Full Information
NCT ID
NCT00764725
First Posted
October 1, 2008
Last Updated
December 22, 2008
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT00764725
Brief Title
Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT)
Acronym
SWEFOT
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 Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
487 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
MTX+SSZ+Plaquenil
Arm Title
B
Arm Type
Active Comparator
Arm Description
MTX+Infliximab
Intervention Type
Drug
Intervention Name(s)
conventional DMARD combination
Other Intervention Name(s)
MTX=Methotrexate, SSZ=Sulfasalazine, Plaquenil=HCQ
Intervention Description
MTX+SSZ+Plaquenil; can be changed to MTX+cyclosporin within protocol
Intervention Type
Biological
Intervention Name(s)
MTX plus anti-TNF
Other Intervention Name(s)
infliximab=Remicade
Intervention Description
MTX + infliximab; can be changed to MTX + etanercept within protocol
Primary Outcome Measure Information:
Title
EULAR individual response
Time Frame
12 months
Secondary Outcome Measure Information:
Title
All core set variables; function; x-ray; health-economic
Time Frame
6-24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
RA, symptom duration < 12 months
Exclusion Criteria:
Contraindication to any of the trial medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Bratt, MD PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
33179071
Citation
Miller H, Wallman JK, Petersson IF, Saevarsdottir S, Soderling J, Ernestam S, Askling J, van Vollenhoven R, Neovius M. Mortality over 14 years in MTX-refractory patients randomized to a strategy of addition of infliximab or sulfasalazine and hydroxychloroquine. Rheumatology (Oxford). 2021 May 14;60(5):2217-2222. doi: 10.1093/rheumatology/keaa553.
Results Reference
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PubMed Identifier
32433827
Citation
Olofsson T, Wallman JK, Joud A, Schelin MEC, Ernestam S, van Vollenhoven R, Saevarsdottir S, Lampa J. Pain Over Two Years After Start of Biologic Versus Conventional Combination Treatment in Early Rheumatoid Arthritis: Results From a Swedish Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2021 Sep;73(9):1312-1321. doi: 10.1002/acr.24264. Epub 2021 Aug 2.
Results Reference
derived
PubMed Identifier
31244356
Citation
Hambardzumyan K, Hermanrud C, Marits P, Vivar N, Ernestam S, Wallman JK, van Vollenhoven RF, Fogdell-Hahn A, Saevarsdottir S; SWEFOT study group. Association of female sex and positive rheumatoid factor with low serum infliximab and anti-drug antibodies, related to treatment failure in early rheumatoid arthritis: results from the SWEFOT trial population. Scand J Rheumatol. 2019 Sep;48(5):362-366. doi: 10.1080/03009742.2019.1602670. Epub 2019 Jun 27.
Results Reference
derived
PubMed Identifier
30709958
Citation
Hambardzumyan K, Bolce RJ, Wallman JK, van Vollenhoven RF, Saevarsdottir S. Serum Biomarkers for Prediction of Response to Methotrexate Monotherapy in Early Rheumatoid Arthritis: Results from the SWEFOT Trial. J Rheumatol. 2019 Jun;46(6):555-563. doi: 10.3899/jrheum.180537. Epub 2019 Feb 1.
Results Reference
derived
PubMed Identifier
28879052
Citation
Levitsky A, Brismar K, Hafstrom I, Hambardzumyan K, Lourdudoss C, van Vollenhoven RF, Saevarsdottir S. Obesity is a strong predictor of worse clinical outcomes and treatment responses in early rheumatoid arthritis: results from the SWEFOT trial. RMD Open. 2017 Aug 9;3(2):e000458. doi: 10.1136/rmdopen-2017-000458. eCollection 2017.
Results Reference
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PubMed Identifier
28879043
Citation
Platten M, Kisten Y, Kalvesten J, Arnaud L, Forslind K, van Vollenhoven R. Fully automated joint space width measurement and digital X-ray radiogrammetry in early RA. RMD Open. 2017 Jun 29;3(1):e000369. doi: 10.1136/rmdopen-2016-000369. eCollection 2017.
Results Reference
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PubMed Identifier
27992691
Citation
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Results Reference
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PubMed Identifier
27015295
Citation
Eriksson JK, Wallman JK, Miller H, Petersson IF, Ernestam S, Vivar N, van Vollenhoven RF, Neovius M. Infliximab Versus Conventional Combination Treatment and Seven-Year Work Loss in Early Rheumatoid Arthritis: Results of a Randomized Swedish Trial. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1758-1766. doi: 10.1002/acr.22899.
Results Reference
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PubMed Identifier
26958364
Citation
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Results Reference
derived
PubMed Identifier
26420684
Citation
Levitsky A, Erlandsson MC, van Vollenhoven RF, Bokarewa MI. Serum survivin predicts responses to treatment in active rheumatoid arthritis: a post hoc analysis from the SWEFOT trial. BMC Med. 2015 Sep 30;13:247. doi: 10.1186/s12916-015-0485-2.
Results Reference
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PubMed Identifier
26213309
Citation
van Vollenhoven RF, Bolce R, Hambardzumyan K, Saevarsdottir S, Forslind K, Petersson IF, Sasso EH, Hwang CC, Segurado OG, Geborek P. Brief report: enhancement of patient recruitment in rheumatoid arthritis clinical trials using a multi-biomarker disease activity score as an inclusion criterion. Arthritis Rheumatol. 2015 Nov;67(11):2855-60. doi: 10.1002/art.39274.
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PubMed Identifier
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Citation
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Learn more about this trial
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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