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NCT03961204 · ClinicalTrials.gov registry record · Phase 4
Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)
A Phase 4 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 662
- Enrollment target
NCT03961204: Completed Phase 4 study, sponsored by EMD Serono Research & Development Institute.
NCT03961204 is a Phase 4 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 662 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03961204, a Phase 4 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 662 participants
- Enrollment target
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).
Primary Outcome
EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory \& cerebral functions, as well as walking ability. EDDS is a scale from 0-10 that evaluates a person with Multiple Sclerosis (MS) disability/neurologic function level where 0=normal and 10=death due to MS. Score of 7.0 is defined as unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair an
Interventions
- OTHER Data Collection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 662 participants |
| Start Date | 2019-08-15 |
| Est. Completion | 2021-05-13 |
| Phase | Phase 4 |
What the finished NCT03961204 record still lists
NCT03961204 is an interventional study that assigns participants to a tested intervention. The registered 662 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (28% higher).
The record links to 0 conditions, and to 1 intervention - of which Data Collection is the first listed.
NCT03961204 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03961204 about?
NCT03961204 is a clinical study titled "Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)". 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 pre...
What is the current status of trial NCT03961204?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 662 participants. The study started on 2019-08-15. Estimated completion is 2021-05-13.
What interventions are being tested in trial NCT03961204?
The interventions under investigation include: Data Collection (OTHER).
Who is sponsoring clinical trial NCT03961204?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03961204's enrollment target sits among peer trials
662 120th of 2000 higher than 1,881 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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