Head-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

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Glinatsi , D , Heiberg , M S , Rudin , A , Nordstrom , D , Haavardsholm , E A , Gudbjornsson , B , Ostergaard , M , Uhlig , T , Grondal , G , Horslev-Petersen , K , van Vollenhoven , R & Hetland , M L 2017 , ' Head-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 ' , Trials , vol. 18 , 161 . https://doi.org/10.1186/s13063-017-1891-x

Title: Head-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
Author: Glinatsi, Daniel; Heiberg, Marte S.; Rudin, Anna; Nordstrom, Dan; Haavardsholm, Espen A.; Gudbjornsson, Bjorn; Ostergaard, Mikkel; Uhlig, Till; Grondal, Gerdur; Horslev-Petersen, Kim; van Vollenhoven, Ronald; Hetland, Merete L.
Contributor: University of Helsinki, Clinicum
Date: 2017-04-04
Language: eng
Number of pages: 17
Belongs to series: Trials
ISSN: 1745-6215
URI: http://hdl.handle.net/10138/229032
Abstract: Background: New 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. Methods/design: In 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 Discussion: NORD-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.
Subject: Rheumatoid arthritis
Early treatment
Biological treatment
Aggressive conventional treatment
Sustained remission
De-escalation strategy
EARLY RHEUMATOID-ARTHRITIS
MODIFYING ANTIRHEUMATIC DRUGS
ADALIMUMAB PLUS METHOTREXATE
PLACEBO-CONTROLLED TRIAL
LOW DISEASE-ACTIVITY
COMBINATION THERAPY
RHEUMATOLOGY/EUROPEAN LEAGUE
RADIOGRAPHIC PROGRESSION
SUBCUTANEOUS ABATACEPT
INADEQUATE RESPONSE
3121 General medicine, internal medicine and other clinical medicine
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