Multiple Sclerosis Clinical Trial

Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

Summary

The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants completing the Double-blind Treatment Period prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants are diagnosed with RMS (relapsing-remitting multiple sclerosis [RRMS] or secondary progressive multiple sclerosis [SPMS] with relapses) in accordance with 2017 Revised McDonald criteria (Thompson 2018)
Participants with one or more documented relapses within the 2 years before Screening with either: a. one relapse which occurred within the last year prior to randomization, OR b. the presence of at least 1 gadolinium-enhancing (Gd+) T1 lesion within 6 months prior to randomization
Participants have Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening and Baseline (Day 1). Participants with an EDSS score <= 2 at Screening and Baseline (Day 1) are only eligible for participation if their disease duration (time since onset of symptoms) is no more than 10 years
Participants are neurologically stable for >= 30 days prior to both screening and baseline (Day 1)
Female participants must be neither pregnant nor breast-feeding or must lack child-bearing potential (as defined by either: post-menopausal or surgically sterile), or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
Male participants must refrain from donating sperm and/or abstain from intercourse with women of child-bearing potential or use an effective method of contraception for the duration of the study and at least 2 years after study intervention due to the long elimination period for teriflunomide of 2 years, unless the participant undergoes an accelerated elimination procedure
Participants have given written informed consent prior to any study-related procedure
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants diagnosed with Progressive MS, in accordance with the 2017 Revised McDonald criteria as follows: a). Participants with Primary Progressive MS. b).

Participants with secondary progressive MS without evidence of relapse

Disease duration more than (>) 10 years in participants with an EDSS =< 2.0 at screening and Baseline (Day 1)
Immunologic disorder other than MS, or any other condition requiring oral, intravenous (IV) , intramuscular, or intra-articular corticosteroid therapy, with the exception of well-controlled Type 2 diabetes mellitus or well controlled thyroid disease
Other protocol defined exclusion criteria could apply.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1124

Study ID:

NCT04338022

Recruitment Status:

Terminated

Sponsor:

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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There are 50 Locations for this study

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Research Site 629
Mobile Alabama, 36693, United States
Research Site 614
Phoenix Arizona, 85013, United States
Research Site 677
Phoenix Arizona, 85018, United States
Research Site 642
Long Beach California, 90806, United States
Research Site 644
Pasadena California, 91105, United States
Research Site 672
San Diego California, 92121, United States
Research Site 634
Stamford Connecticut, 06905, United States
Research Site 656
Washington District of Columbia, 20007, United States
Research Site 616
Boca Raton Florida, 33428, United States
Research Site 625
Maitland Florida, 32751, United States
Research Site 617
Miami Florida, 33136, United States
Research Site 643
Ormond Beach Florida, 32174, United States
Research site 645
Saint Petersburg Florida, 33713, United States
Research Site 652
Tallahassee Florida, 32308, United States
Research Site 621
Elk Grove Village Illinois, 60007, United States
Research Site 649
Northbrook Illinois, 60062, United States
Research Site 675
Peoria Illinois, 61637, United States
Research Site 628
Rolling Meadows Illinois, 60008, United States
Research Site 624
Indianapolis Indiana, 46256, United States
Research Site 632
Kansas City Kansas, 66160, United States
Research Site 653
New Orleans Louisiana, 70115, United States
Research Site 623
Baltimore Maryland, 21201, United States
Research Site 633
Boston Massachusetts, 02114, United States
Research Site 639
Foxboro Massachusetts, 02035, United States
Research Site 635
Lawrence Massachusetts, 01843, United States
Research Site 636
Worcester Massachusetts, 01655, United States
Research Site 613
Detroit Michigan, 48201, United States
Research Site 612
Farmington Hills Michigan, 48334, United States
Research Site 638
Saint Louis Missouri, 63110, United States
Research Site 664
Saint Louis Missouri, 63131, United States
Research Site 668
Omaha Nebraska, 68130, United States
Research Site 626
Las Vegas Nevada, 89106, United States
Research Site 667
Audubon New Jersey, 08106, United States
Research Site 620
Patchogue New York, 11772, United States
Research Site 663
Akron Ohio, 44320, United States
Research Site 630
Toledo Ohio, 43614, United States
Research Site 611
Oklahoma City Oklahoma, 73104, United States
Research Site 641
Oklahoma City Oklahoma, 73104, United States
Research Site 615
Springfield Oregon, 97477, United States
Research Site 647
Willow Grove Pennsylvania, 19090, United States
Research Site 648
Knoxville Tennessee, 37922, United States
Research Site 627
Nashville Tennessee, 37205, United States
Research Site 637
Nashville Tennessee, 37215, United States
Research Site 662
Dallas Texas, 75214, United States
Research Site 631
Houston Texas, 77030, United States
Research Site 650
Lubbock Texas, 79410, United States
Research Site 619
Round Rock Texas, 78681, United States
Research Site 676
Layton Utah, 84041, United States
Research Site 673
Alexandria Virginia, 22310, United States
Research Site 654
Virginia Beach Virginia, 23456, United States
Research Site 651
Milwaukee Wisconsin, 53226, United States
Research Site 566
Ciudad Autonoma Buenos Aires , , Argentina
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Ciudad Autonoma Buenos Aires , , Argentina
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Ciudad Autonoma Buenos Aires , , Argentina
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Ciudad Autonoma Buenos Aires , , Argentina
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Ciudad Autonoma de Buenos Aires , , Argentina
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Ciudad Autonoma de Buenos Aires , , Argentina
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Ciudad Autonoma de Buenos Aires , , Argentina
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Cordoba , , Argentina
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Godoy Cruz , , Argentina
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Guaymallen , , Argentina
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Rosario , , Argentina
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Rosario , , Argentina
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Salta , , Argentina
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San Juan , , Argentina
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San Miguel de Tucuman , , Argentina
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Auchenflower , , Australia
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Concord , , Australia
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Hobart , , Australia
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Liverpool , , Australia
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New Lambton Heights , , Australia
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St Leonards , , Australia
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Innsbruck , , Austria
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Linz , , Austria
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Salzburg , , Austria
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Vienna , , Austria
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Bruxelles , , Belgium
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Bruxelles , , Belgium
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Kortrijk , , Belgium
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La Louvière , , Belgium
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Liège , , Belgium
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Overpelt , , Belgium
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Roeselare , , Belgium
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Bihac , , Bosnia and Herzegovina
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Mostar , , Bosnia and Herzegovina
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Sarajevo , , Bosnia and Herzegovina
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Pleven , , Bulgaria
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Pleven , , Bulgaria
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Plovdiv , , Bulgaria
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Plovdiv , , Bulgaria
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Sofia , , Bulgaria
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Sofia , , Bulgaria
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Sofia , , Bulgaria
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Sofia , , Bulgaria
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Sofia , , Bulgaria
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Sofia , , Bulgaria
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Greenfield Park , , Canada
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Levis , , Canada
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Moncton , , Canada
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Montreal , , Canada
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Toronto , , Canada
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Barranquilla , , Colombia
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Barranquilla , , Colombia
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Medellin , , Colombia
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Medellin , , Colombia
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Osijek , , Croatia
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Rijeka , , Croatia
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Varazdin , , Croatia
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Zagreb , , Croatia
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Zagreb , , Croatia
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Brno , , Czechia
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Brno , , Czechia
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Hradec Kralove , , Czechia
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Hradec Kralove , , Czechia
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Jihlava , , Czechia
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Ostrava , , Czechia
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Pardubice , , Czechia
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Plzen-Bory , , Czechia
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Praha 10 , , Czechia
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Praha 2 , , Czechia
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Praha 4 - Krc , , Czechia
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Praha 5 , , Czechia
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Tallinn , , Estonia
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Tartu , , Estonia
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Turku , , Finland
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Bron cedex , , France
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Caen cedex 9 , , France
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Grenoble cedex 09 , , France
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Lille cedex , , France
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Lille , , France
Reserach Site 505
Montpellier , , France
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Nantes cedex 1 , , France
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Nice Cedex 1 , , France
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Rennes cedex 09 , , France
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Rouen Cedex , , France
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Toulouse cedex 9 , , France
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Tbilisi , , Georgia
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Tbilisi , , Georgia
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Tbilisi , , Georgia
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Tbilisi , , Georgia
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Tbilisi , , Georgia
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Tbilisi , , Georgia
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Tbilisi , , Georgia
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Tbilisi , , Georgia
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Tbilisi , , Georgia
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Tbilisi , , Georgia
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Bamberg , , Germany
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Bayreuth , , Germany
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Berlin , , Germany
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Bochum , , Germany
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Bonn , , Germany
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Erbach , , Germany
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Essen , , Germany
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Frankfurt , , Germany
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Hannover , , Germany
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Mannheim , , Germany
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Muenchen , , Germany
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Muenster , , Germany
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Potsdam , , Germany
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Siegen , , Germany
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Ulm , , Germany
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Hong Kong , , Hong Kong
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Hongkong , , Hong Kong
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Shatin , , Hong Kong
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Budapest , , Hungary
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Budapest , , Hungary
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Budapest , , Hungary
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Budapest , , Hungary
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Budapest , , Hungary
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Kistarcsa , , Hungary
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Pecs , , Hungary
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Tatabanya , , Hungary
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Vac , , Hungary
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Hyderabad , , India
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Nashik , , India
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New Delhi , , India
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Ashkelon , , Israel
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Jerusalem , , Israel
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Petah Tikva , , Israel
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Ramat Gan , , Israel
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Rechovot , , Israel
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Safed , , Israel
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Bologna , , Italy
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Chieti , , Italy
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Genova , , Italy
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Messina , , Italy
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Milano , , Italy
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Montichiari , , Italy
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Napoli , , Italy
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Napoli , , Italy
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Reggio Calabria , , Italy
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Roma , , Italy
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Salerno , , Italy
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Verona , , Italy
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Goyang-si , , Korea, Republic of
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Seoul , , Korea, Republic of
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Seoul , , Korea, Republic of
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Seoul , , Korea, Republic of
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Seoul , , Korea, Republic of
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Seoul , , Korea, Republic of
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Seoul , , Korea, Republic of
Research Site 133
Aguascalientes , , Mexico
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Culiacan , , Mexico
Research Site 534
Hoorn , , Netherlands
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Nieuwegein , , Netherlands
Research Site 535
Rotterdam , , Netherlands
Research Site 532
Sittard-Geleen , , Netherlands
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Bydgoszcz , , Poland
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Gdansk , , Poland
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Katowice , , Poland
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Knurow , , Poland
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Lodz , , Poland
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Lublin , , Poland
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Oswiecim , , Poland
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Rzeszów , , Poland
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Warszawa , , Poland
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Warszawa , , Poland
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Barnaul , , Russian Federation
Research Site 368
Ekaterinburg , , Russian Federation
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Kaluga , , Russian Federation
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Kazan , , Russian Federation
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Kirov , , Russian Federation
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Krasnoyarsk , , Russian Federation
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Moscow , , Russian Federation
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Moscow , , Russian Federation
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Nizhniy Novgorod , , Russian Federation
Research Site 367
Perm , , Russian Federation
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Pyatigorsk , , Russian Federation
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Saint-Petersburg , , Russian Federation
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Saratov , , Russian Federation
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Smolensk , , Russian Federation
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St.Petersburg , , Russian Federation
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Tomsk , , Russian Federation
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Ufa , , Russian Federation
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Ulyanovsk , , Russian Federation
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Yaroslavl , , Russian Federation
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Belgrade , , Serbia
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Belgrade , , Serbia
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Belgrade , , Serbia
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Kragujevac , , Serbia
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Nis , , Serbia
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Novi Sad , , Serbia
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Uzice , , Serbia
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Valjevo , , Serbia
Research Site 406
Barcelona , , Spain
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Barcelona , , Spain
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Cadiz , , Spain
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Lleida , , Spain
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Madrid , , Spain
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Madrid , , Spain
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Madrid , , Spain
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Pozuelo de Alarcon , , Spain
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Salt , , Spain
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San Sebastian , , Spain
Research Site 404
Sevilla , , Spain
Research site 713
Kaohsiung , , Taiwan
Research Site 711
Taichung , , Taiwan
Research site 714
Taipei , , Taiwan
Research site 715
Taipei , , Taiwan
Research Site 432
Chernivtsi , , Ukraine
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Kharkiv , , Ukraine
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Kharkiv , , Ukraine
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Kharkiv , , Ukraine
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Kharkiv , , Ukraine
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Kharkiv , , Ukraine
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Kharkiv , , Ukraine
Research Site 422
Kropyvnytskyi , , Ukraine
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Kyiv , , Ukraine
Research Site 426
Lviv , , Ukraine
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Odesa , , Ukraine
Research Site 423
Poltava , , Ukraine
Research Site 427
Sumy , , Ukraine
Research Site 431
Vinnytsia , , Ukraine
Research Site 421
Zaporizhzhia , , Ukraine
Research Site 428
Zaporizhzhia , , Ukraine
Research Site 544
Exeter , , United Kingdom
Research Site 549
Glasgow , , United Kingdom
Research Site 552
Newcastle , , United Kingdom
Research Site 547
Swansea , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1124

Study ID:

NCT04338022

Recruitment Status:

Terminated

Sponsor:


Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

How clear is this clinincal trial information?

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