Multiple Sclerosis Clinical Trial
Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)
Summary
The objective of this study was to collect data both retrospectively and prospectively in order to evaluate the long-term outcomes, durability of effect, and real-world treatment patterns following treatment with Cladribine Tablets or placebo in participants with multiple sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and CLARITY/CLARITY-EXT).
Eligibility Criteria
Inclusion Criteria:
Participants with relapsing remitting multiple sclerosis (RRMS) randomised in CLARITY/CLARITY-EXT clinical trial(s) who have received greater than or equal to (>=) 1 course of in investigational medicinal product (IMP) Cladribine Tablets or placebo
Participants with their first clinical demyelinating event randomised in ORACLE MS clinical trial who have received >= 1 course of IMP Cladribine Tablets or placebo
Participants who has sign informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol
Exclusion Criteria:
Participants who has any uncontrolled disease state other than MS, that in the Investigator's opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
For study participants at selected sites where MRI assessment will be conducted following exclusion criteria will apply to MRI assessments only:
Female study participants who are pregnant
Participants who are taking Cladribine Tablets as part of another study at the time of the start of this study
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There are 7 Locations for this study
Atlanta Georgia, 30327, United States
Chicago Illinois, 60612, United States
Baltimore Maryland, 21201, United States
Latham New York, 12110, United States
Fargo North Dakota, 58103, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19106, United States
Camperdown , , Australia
Linz , , Austria
Hasselt , , Belgium
Seraing , , Belgium
Pleven , , Bulgaria
Shumen , , Bulgaria
Sofia , , Bulgaria
Sofia , , Bulgaria
Stara Zagora , , Bulgaria
Burnaby , , Canada
Gatineau , , Canada
Greenfield Park , , Canada
Ottawa , , Canada
Split , , Croatia
Varaždin , , Croatia
Hradec Kralove , , Czechia
Olomouc , , Czechia
Ostrava-Poruba , , Czechia
Praha 2 , , Czechia
Praha 5 , , Czechia
Teplice , , Czechia
Tallinn , , Estonia
Tartu , , Estonia
Turku , , Finland
Lille , , France
Nimes , , France
Rennes cedex 09 , , France
Tbilisi , , Georgia
Tbilisi , , Georgia
Duesseldorf , , Germany
Hanover , , Germany
Regensburg , , Germany
Rostock , , Germany
Bari , , Italy
Catania , , Italy
Chieti , , Italy
Gallarate , , Italy
Genova , , Italy
Milano , , Italy
Napoli , , Italy
Orbassano , , Italy
Pavia , , Italy
Roma , , Italy
Roma , , Italy
Rome , , Italy
Goyang-si , , Korea, Republic of
Seoul , , Korea, Republic of
Beirut , , Lebanon
Beirut , , Lebanon
Kaunas , , Lithuania
Haukeland , , Norway
Trondheim , , Norway
Gdansk , , Poland
Gdansk , , Poland
Lublin , , Poland
Poznań , , Poland
Warszawa , , Poland
Lisboa , , Portugal
Bucaresti , , Romania
Targu Mures , , Romania
Timisoara , , Romania
Kemerovo , , Russian Federation
Kursk , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Nizhny Novgorod , , Russian Federation
Novosibirsk , , Russian Federation
Rostov-on-don , , Russian Federation
Saint-Petersburg , , Russian Federation
Saint-Petersburg , , Russian Federation
Saint-Petersburg , , Russian Federation
Samara , , Russian Federation
Saratov , , Russian Federation
Smolensk , , Russian Federation
St. Petersburg , , Russian Federation
Tomsk , , Russian Federation
Tyumen , , Russian Federation
Yaroslavl , , Russian Federation
Belgrade , , Serbia
Nis , , Serbia
Córdoba , , Spain
Santa Cruz de Tenerife , , Spain
Göteborg , , Sweden
Lausanne , , Switzerland
Monastir , , Tunisia
Sfax , , Tunisia
Tunis , , Tunisia
Kharkiv , , Ukraine
Vinnytsia , , Ukraine
Nottingham , , United Kingdom
Sheffield , , United Kingdom
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