Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for Multiple Sclerosis (MS)
Purpose
The purpose of this study is to explore the long-term outcomes, durability of effect, and real world treatment patterns in participants previously participating in the Phase 3 oral cladribine in first clinical demyelinating event(ORACLE MS) and Oral Cladribine in participants with relapsing remitting multiple sclerosis, extension study (CLARITY/CLARITY-EXT) clinical trials with the study number of 28821 (NCT00725985), 25643 (NCT00213135) and 27820 (NCT00641537) respectively.
Condition
- Multiple Sclerosis
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Cladribine |
|
Recruiting Locations
University of Maryland, Baltimore - Maryland Center for MS
Baltimore, Maryland 21201
Baltimore, Maryland 21201
More Details
- Status
- Recruiting
- Sponsor
- EMD Serono Research & Development Institute, Inc.