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dc.contributor.authorGlinatsi, Daniel
dc.contributor.authorHeiberg, Marte S
dc.contributor.authorRudin, Anna
dc.contributor.authorNordström, Dan
dc.contributor.authorHaavardsholm, Espen A
dc.contributor.authorGudbjornsson, Bjorn
dc.contributor.authorØstergaard, Mikkel
dc.contributor.authorUhlig, Till
dc.contributor.authorGrondal, Gerdur
dc.contributor.authorHørslev-Petersen, Kim
dc.contributor.authorvan Vollenhoven, Ronald
dc.contributor.authorHetland, Merete L
dc.date.accessioned2017-12-20T14:24:14Z
dc.date.available2017-12-20T14:24:14Z
dc.date.issued2017-04-04
dc.date.submitted2017
dc.identifier.citationHead-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study. 2017, 18 (1):161 Trialsen
dc.identifier.issn1745-6215
dc.identifier.pmid28376912
dc.identifier.doi10.1186/s13063-017-1891-x
dc.identifier.urihttp://hdl.handle.net/2336/620413
dc.descriptionTo access publisher's full text version of this article, please click on the hyperlink in Additional Links field or click on the hyperlink at the top of the page marked Filesen
dc.description.abstractNew targeted therapies and improved treatment strategies have dramatically improved the outcomes of patients with rheumatoid arthritis (RA). However, it is unknown whether different early aggressive interventions can induce stable remission or a low-active disease state that can be maintained with conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy, and whether they differ in efficacy and safety. The Nordic Rheumatic Diseases Strategy Trials And Registries (NORD-STAR) study will assess and compare (1) the proportion of patients who achieve remission in a head-to-head comparison between csDMARD plus glucocorticoid therapy and three different biological DMARD (bDMARD) therapies with different modes of action and (2) two de-escalation strategies in patients who respond to first-line therapy.
dc.description.abstractIn a pragmatic, 80-160-week, multicenter, randomized, open-label, assessor-blinded, phase 4 study, 800 patients with early RA (symptom duration less than 24 months) are randomized 1:1:1:1 to one of four different treatment arms: (1) aggressive csDMARD therapy with methotrexate + sulphasalazine + hydroxychloroquine + i.a. glucocorticoids (arm 1A) or methotrexate + prednisolone p.o. (arm 1B), (2) methotrexate + certolizumab-pegol, (3) methotrexate + abatacept, or (4) methotrexate + tocilizumab. The primary clinical endpoint is the proportion of patients reaching Clinical Disease Activity Index (CDAI) remission at week 24. Patients in stable remission over 24 consecutive weeks enter part 2 of the study earliest after 48 weeks. Patients not achieving sustained CDAI remission over 24 consecutive weeks, exit the study after 80 weeks. In part 2, patients are re-randomized to two different de-escalation strategies, either immediate or delayed (after 24 weeks) tapering, followed by cessation of study medication. All patients remain on stable doses of methotrexate. The primary clinical endpoint in part 2 is the proportion of patients in remission (CDAI ≤2.8) 24 weeks after initiating treatment de-escalation. Radiographic assessment will be performed regularly throughout the trial, and blood and urine samples will be stored in a biobank for later biomarker analyses.
dc.description.abstractNORD-STAR is the first investigator-initiated, randomized, early RA trial to compare (1) csDMARD and three different bDMARD therapies head to head and (2) two different de-escalation strategies. The trial has the potential to identify which treatment strategy to apply in early RA to achieve the best possible outcomes for both patients and society.
dc.description.abstractNCT01491815 and NCT02466581 . Registered on 8 December 2011 and May 2015, respectively. EudraCT: 2011-004720-35.
dc.description.sponsorshipBristol-Myers Squibb Academy of Finland Danish Regions Finska Lakaresallskapet Icelandic Society for Rheumatology research fund Liv och Halsa Association Nordforsk Norwegian Regional Health Authorities South-Eastern Norway Regional Health Authority Stockholm County Council Swedish Research Council University Hospital Iceland Research Funden
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.urlhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5381054/pdf/13063_2017_Article_1891.pdfen
dc.rightsArchived with thanks to Trialsen
dc.subjectRheumatoid arthritisen
dc.subjectIktsýkien
dc.subjectLyfjameðferðen
dc.subjectLíftæknien
dc.subjectRHE12en
dc.subject.meshArthritis, Rheumatoiden
dc.subject.meshTreatment Outcomeen
dc.subject.meshBiological Therapyen
dc.titleHead-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study.en
dc.typeArticleen
dc.contributor.department[ 1 ] Rigshosp, Ctr Head & Orthopaed, Ctr Rheumatol & Spine Dis, Copenhagen Ctr Arthrit Res COPECARE, Nordre Ringvej 57, DK-2600 Glostrup, Denmark [ 2 ] Diakonhjemmet Hosp, Dept Rheumatol, Box 23 Vinderen, N-0219 Oslo, Norway Show more [ 3 ] Sahlgrens Univ Hosp, Clin Rheumatol Res Ctr, Grona Straket 14, S-41345 Gothenburg, Sweden Show more [ 4 ] Gothenburg Univ, Sahlgrenska Acad, Dept Rheumatol & Inflammat Res, Box 480405 30, Gothenburg, Sweden Show more [ 5 ] Univ Helsinki, Cent Hosp, Stenbacksgatan 9 A, FIN-00290 Helsinki, Finland Show more [ 6 ] Univ Helsinki, Div Internal Med, Stenbacksgatan 9 A, FIN-00290 Helsinki, Finland Show more [ 7 ] Univ Hosp, Ctr Rheumatol Res, V Hringbraut 101, IS-101 Reykjavik, Iceland Show more [ 8 ] Univ Iceland, Fac Med, Reykjavik, Iceland Show more [ 9 ] Univ Copenhagen, Fac Hlth & Med Sci, Dept Clin Med, Copenhagen, Denmark Show more [ 10 ] Univ Hosp, Dept Rheumatol, IS-101 Reykjavik, Iceland [ 11 ] Diakonhjemmet Hosp, Dept Rheumatol, Natl Advisory Unit Rehabil Rheumatol, Box 23 Vinderen, N-0319 Oslo, Norway [ 12 ] King Christian 10th Hosp Rheumat Dis, Dept Rheumatol, Toldbodgade 3, DK-6300 Grasten, Denmark Show more [ 13 ] Univ Southern Denmark, Inst Reg Hlth Res, Grasten, Denmark Show more [ 14 ] Karolinska Inst, Unit Clin Therapy Res, Inflammatory Dis, S-17176 Stockholm, Swedenen
dc.identifier.journalTrialsen
dc.rights.accessOpen Access - Opinn aðganguren
refterms.dateFOA2018-09-12T16:56:51Z
html.description.abstractNew targeted therapies and improved treatment strategies have dramatically improved the outcomes of patients with rheumatoid arthritis (RA). However, it is unknown whether different early aggressive interventions can induce stable remission or a low-active disease state that can be maintained with conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy, and whether they differ in efficacy and safety. The Nordic Rheumatic Diseases Strategy Trials And Registries (NORD-STAR) study will assess and compare (1) the proportion of patients who achieve remission in a head-to-head comparison between csDMARD plus glucocorticoid therapy and three different biological DMARD (bDMARD) therapies with different modes of action and (2) two de-escalation strategies in patients who respond to first-line therapy.
html.description.abstractIn a pragmatic, 80-160-week, multicenter, randomized, open-label, assessor-blinded, phase 4 study, 800 patients with early RA (symptom duration less than 24 months) are randomized 1:1:1:1 to one of four different treatment arms: (1) aggressive csDMARD therapy with methotrexate + sulphasalazine + hydroxychloroquine + i.a. glucocorticoids (arm 1A) or methotrexate + prednisolone p.o. (arm 1B), (2) methotrexate + certolizumab-pegol, (3) methotrexate + abatacept, or (4) methotrexate + tocilizumab. The primary clinical endpoint is the proportion of patients reaching Clinical Disease Activity Index (CDAI) remission at week 24. Patients in stable remission over 24 consecutive weeks enter part 2 of the study earliest after 48 weeks. Patients not achieving sustained CDAI remission over 24 consecutive weeks, exit the study after 80 weeks. In part 2, patients are re-randomized to two different de-escalation strategies, either immediate or delayed (after 24 weeks) tapering, followed by cessation of study medication. All patients remain on stable doses of methotrexate. The primary clinical endpoint in part 2 is the proportion of patients in remission (CDAI ≤2.8) 24 weeks after initiating treatment de-escalation. Radiographic assessment will be performed regularly throughout the trial, and blood and urine samples will be stored in a biobank for later biomarker analyses.
html.description.abstractNORD-STAR is the first investigator-initiated, randomized, early RA trial to compare (1) csDMARD and three different bDMARD therapies head to head and (2) two different de-escalation strategies. The trial has the potential to identify which treatment strategy to apply in early RA to achieve the best possible outcomes for both patients and society.
html.description.abstractNCT01491815 and NCT02466581 . Registered on 8 December 2011 and May 2015, respectively. EudraCT: 2011-004720-35.


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