Phase 4
Completed N=662
Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)
Multiple Sclerosis (MS)
Source: ClinicalTrials.gov NCT03961204 ↗
Enrolled (actual)
662
Serious AEs
0.2%
Results posted
May 2022
Primary outcomePrimary: Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher — 8.2 percentage of participant
◆ Published Evidence
Established
54citations · ~18 / year
Long-term follow-up of patients with relapsing multiple sclerosis from the CLARITY/CLARITY Extension cohort of CLASSIC-MS: An ambispective study.
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).
Linked Publications
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Long-term follow-up of patients with relapsing multiple sclerosis from the CLARITY/CLARITY Extension cohort of CLASSIC-MS: An ambispective study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher |
8.2 | — |
| SECONDARY Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher |
13.9 | — |
| SECONDARY Clinical and Demographic Characteristic: Age, Disease Duration |
50.5; 47.1; 19.82; 16.82 | — |
| SECONDARY Number of Participants in Each Category of Clinical and Demographic Characteristics |
251; 171; 127; 78; 368; 244 | — |
| SECONDARY Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score |
2.44; 2.38; 3.23; 3.32 | — |
| SECONDARY Clinical Characteristic: Number of Relapses |
1.3; 1.3 | — |
| SECONDARY Number of Total T1-weighted (T1-W) Lesions |
12.7; 16.1 | — |
| SECONDARY Number of Total T2-weighted (T2-W) Lesions |
20.2; 25.1 | — |
| SECONDARY T1-weighted (T1-W) Lesion Volume |
1.655; 6.773 | — |
| SECONDARY T2-weighted (T2-W) Lesion Volume |
4.920; 14.664 | — |
| SECONDARY Total Brain Volume |
1472.559; 1417.431 | — |
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
Data sourced from ClinicalTrials.gov (NCT03961204) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.