Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)
Completed · Phase 4
Conditions studied: Multiple Sclerosis (MS)
In brief
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).
Key facts
- Study ID
- NCT03961204
- Run by
- EMD Serono Research & Development Institute, Inc.
- People needed
- 662
- Starts
- 2019-08-15
- Expected to finish
- 2021-05-13
- Last updated by the study team
- 2023-10-31
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Rush University Medical Center — Chicago, Illinois, United States
- University of Maryland, Baltimore - Maryland Center for MS — Baltimore, Maryland, United States
- Empire Neurology, PC - Empire Neurology PC — Latham, New York, United States
- Sanford Neuro Health Center - Neurology — Fargo, North Dakota, United States
- OMRF — Oklahoma City, Oklahoma, United States
- Rowan University School of Osteopathic Medicine - Department of Medicine — Philadelphia, Pennsylvania, United States
- University of Sydney — Camperdown, Australia
- Barmherzige Brueder Konventspital Linz - Abteilung fuer Neurologie — Linz, Austria
- Limburgs Universitair Centrum — Hasselt, Belgium
- University Hospital of Liege — Seraing, Belgium
- Military Medical Academy - MHAT - Pleven — Pleven, Bulgaria
- MHAT - Shumen, AD — Shumen, Bulgaria
- MHAT - "National Heart Hospital" EAD - Multiple Clinics — Sofia, Bulgaria
- University Hospital "Saint Naum" — Sofia, Bulgaria
- Multiprofile Hospital for Active Treatment - Stara Zagora — Stara Zagora, Bulgaria
- Burnaby Hospital Vancouver — Burnaby, Canada
- Clinique Neuro-Outaouais — Gatineau, Canada
- Recherche Sepmus, Inc. — Greenfield Park, Canada
- The Ottawa Hospital - General Campus — Ottawa, Canada
- Clinical Hospital Centar Split — Split, Croatia
- General Hospital Varazdin — Varaždin, Croatia
- Privatni ordinace - neurologie - Nestatni zdravotnicke zarizeni — Hradec Králové, Czechia
- Fakultni nemocnice Olomouc - Neurologicka klinika — Olomouc, Czechia
- Fakultni nemocnice Ostrava - Dept of Neurology — Ostrava-Poruba, Czechia
- MS Center of Atlanta — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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