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NCT03933202 · ClinicalTrials.gov registry record
A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
A clinical trial, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- 291
- Enrollment target
NCT03933202: Completed study, sponsored by EMD Serono Research & Development Institute.
NCT03933202 is a clinical trial that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 291 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03933202 has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- 291 participants
- Enrollment target
Study Summary
To evaluate the effectiveness, safety and Patient-Reported Outcomes (PROs) of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS), who transition to cladribine tablets after suboptimal response to any oral or infusion Disease-Modifying Drugs (DMDs) approved in the United States (US) for RMS in a real-world-setting.
Primary Outcome
A relapse was defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25.
Interventions
- DRUG Cladribine Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2019-07-22 |
| Est. Completion | 2024-11-11 |
What the finished NCT03933202 record still lists
NCT03933202 is an observational study that tracks outcomes without assigning an intervention. The registered 291 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Cladribine Tablets is the first listed.
NCT03933202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03933202 about?
NCT03933202 is a clinical study titled "A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)". To evaluate the effectiveness, safety and Patient-Reported Outcomes (PROs) of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS), who transition to cladribine tablets after suboptimal respons...
What is the current status of trial NCT03933202?
This trial is currently completed. The enrollment target is 291 participants. The study started on 2019-07-22. Estimated completion is 2024-11-11.
What interventions are being tested in trial NCT03933202?
The interventions under investigation include: Cladribine Tablets (DRUG).
Who is sponsoring clinical trial NCT03933202?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
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