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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)

NCT ID: NCT00764725

Last Updated: 2008-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

487 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

MTX+SSZ+Plaquenil

Group Type ACTIVE_COMPARATOR

conventional DMARD combination

Intervention Type DRUG

MTX+SSZ+Plaquenil; can be changed to MTX+cyclosporin within protocol

B

MTX+Infliximab

Group Type ACTIVE_COMPARATOR

MTX plus anti-TNF

Intervention Type BIOLOGICAL

MTX + infliximab; can be changed to MTX + etanercept within protocol

Interventions

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conventional DMARD combination

MTX+SSZ+Plaquenil; can be changed to MTX+cyclosporin within protocol

Intervention Type DRUG

MTX plus anti-TNF

MTX + infliximab; can be changed to MTX + etanercept within protocol

Intervention Type BIOLOGICAL

Other Intervention Names

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MTX=Methotrexate, SSZ=Sulfasalazine, Plaquenil=HCQ infliximab=Remicade

Eligibility Criteria

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Inclusion Criteria

* RA, symptom duration \< 12 months

Exclusion Criteria

* Contraindication to any of the trial medications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Karolinska University Hospital

Principal Investigators

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Johan Bratt, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

References

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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.

Reference Type DERIVED
PMID: 33179071 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32433827 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31244356 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30709958 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28879052 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28879043 (View on PubMed)

Hambardzumyan K, Saevarsdottir S, Forslind K, Petersson IF, Wallman JK, Ernestam S, Bolce RJ, van Vollenhoven RF. A Multi-Biomarker Disease Activity Score and the Choice of Second-Line Therapy in Early Rheumatoid Arthritis After Methotrexate Failure. Arthritis Rheumatol. 2017 May;69(5):953-963. doi: 10.1002/art.40019. Epub 2017 Mar 31.

Reference Type DERIVED
PMID: 27992691 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27015295 (View on PubMed)

Hambardzumyan K, Bolce RJ, Saevarsdottir S, Forslind K, Wallman JK, Cruickshank SE, Sasso EH, Chernoff D, van Vollenhoven RF. Association of a multibiomarker disease activity score at multiple time-points with radiographic progression in rheumatoid arthritis: results from the SWEFOT trial. RMD Open. 2016 Mar 1;2(1):e000197. doi: 10.1136/rmdopen-2015-000197. eCollection 2016.

Reference Type DERIVED
PMID: 26958364 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26420684 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26213309 (View on PubMed)

Kastbom A, Forslind K, Ernestam S, Geborek P, Karlsson JA, Petersson IF, Saevarsdottir S, Klareskog L, van Vollenhoven RF, Lundberg K. Changes in the anticitrullinated peptide antibody response in relation to therapeutic outcome in early rheumatoid arthritis: results from the SWEFOT trial. Ann Rheum Dis. 2016 Feb;75(2):356-61. doi: 10.1136/annrheumdis-2014-205698. Epub 2014 Dec 30.

Reference Type DERIVED
PMID: 25550338 (View on PubMed)

Hambardzumyan K, Bolce R, Saevarsdottir S, Cruickshank SE, Sasso EH, Chernoff D, Forslind K, Petersson IF, Geborek P, van Vollenhoven RF. Pretreatment multi-biomarker disease activity score and radiographic progression in early RA: results from the SWEFOT trial. Ann Rheum Dis. 2015 Jun;74(6):1102-9. doi: 10.1136/annrheumdis-2013-204986. Epub 2014 May 8.

Reference Type DERIVED
PMID: 24812287 (View on PubMed)

Eriksson JK, Karlsson JA, Bratt J, Petersson IF, van Vollenhoven RF, Ernestam S, Geborek P, Neovius M. Cost-effectiveness of infliximab versus conventional combination treatment in methotrexate-refractory early rheumatoid arthritis: 2-year results of the register-enriched randomised controlled SWEFOT trial. Ann Rheum Dis. 2015 Jun;74(6):1094-101. doi: 10.1136/annrheumdis-2013-205060. Epub 2014 Apr 15.

Reference Type DERIVED
PMID: 24737786 (View on PubMed)

Saevarsdottir S, Rezaei H, Geborek P, Petersson I, Ernestam S, Albertsson K, Forslind K, van Vollenhoven RF; SWEFOT study group. Current smoking status is a strong predictor of radiographic progression in early rheumatoid arthritis: results from the SWEFOT trial. Ann Rheum Dis. 2015 Aug;74(8):1509-14. doi: 10.1136/annrheumdis-2013-204601. Epub 2014 Apr 4.

Reference Type DERIVED
PMID: 24706006 (View on PubMed)

Eriksson JK, Neovius M, Bratt J, Petersson IF, van Vollenhoven RF, Geborek P, Ernestam S. Biological vs. conventional combination treatment and work loss in early rheumatoid arthritis: a randomized trial. JAMA Intern Med. 2013 Aug 12;173(15):1407-14. doi: 10.1001/jamainternmed.2013.7801.

Reference Type DERIVED
PMID: 23817631 (View on PubMed)

van Vollenhoven RF, Geborek P, Forslind K, Albertsson K, Ernestam S, Petersson IF, Chatzidionysiou K, Bratt J; Swefot study group. Conventional combination treatment versus biological treatment in methotrexate-refractory early rheumatoid arthritis: 2 year follow-up of the randomised, non-blinded, parallel-group Swefot trial. Lancet. 2012 May 5;379(9827):1712-20. doi: 10.1016/S0140-6736(12)60027-0. Epub 2012 Mar 29.

Reference Type DERIVED
PMID: 22464340 (View on PubMed)

Saevarsdottir S, Wallin H, Seddighzadeh M, Ernestam S, Geborek P, Petersson IF, Bratt J, van Vollenhoven RF; SWEFOT Trial Investigators Group. Predictors of response to methotrexate in early DMARD naive rheumatoid arthritis: results from the initial open-label phase of the SWEFOT trial. Ann Rheum Dis. 2011 Mar;70(3):469-75. doi: 10.1136/ard.2010.139212. Epub 2010 Dec 13.

Reference Type DERIVED
PMID: 21149498 (View on PubMed)

Other Identifiers

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P0 3013 Swefot

Identifier Type: -

Identifier Source: org_study_id