At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 662 enrolled
Drug / intervention
Data Collectionother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials (CLASSIC-MS)
EMD Serono Research & Development Institute, Inc.·interventional·Posted May 23, 2019·Updated Oct 31, 2023
In Brief
A Phase 4 clinical trial evaluating Data Collection for Multiple Sclerosis (MS). Completed, enrolled 662 participants across 99 sites in 29 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis (MS)
CountriesAustralia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, Estonia, Finland, France, Georgia, Germany, Italy, Lebanon, Lithuania, Norway, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Sweden, Switzerland, Tunisia, Ukraine, United Kingdom, United States
CollaboratorsMerck KGaA, Darmstadt, Germany
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
First PostedMay 2019
Enrollment StartAug 2019
Primary CompletionFeb 2021
Study CompletionMay 2021
TodayJul 2026
First PostedMay 23, 2019
Enrollment StartAug 15, 2019
Primary CompletionFeb 27, 2021
Study CompletionMay 13, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.1 years ago
Interventions
Data Collectionother
No study treatment was administered as part of this study