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Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)
Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)

NCT03961204

CompletedPhase 4

Sponsor: EMD Serono Research & Development Institute, Inc.

Conditions: Multiple Sclerosis (MS)

Interventions: Data Collection

Countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia

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 overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (99)
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Baltimore, Maryland, United States
  • Latham, New York, United States
  • Fargo, North Dakota, United States
  • Oklahoma City, Oklahoma, United States
  • Philadelphia, Pennsylvania, 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 Králové, Czechia
  • Olomouc, Czechia
  • Ostrava-Poruba, Czechia
  • Prague, Czechia
  • Prague, Czechia
  • Teplice, Czechia
  • Tallinn, Estonia
  • Tartu, Estonia
  • + 69 more on CT.gov