Multiple Sclerosis MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For Main Study and MRI Sub-Study: 1. Patients with MS randomised in CLARITY/CLARITY-EXT clinical trial(s) who have received = 1 course of IMP (Cladribine Tablets or placebo). or Patients with their FCDE randomised in ORACLE MS clinical trial who have received = 1 course of IMP (Cladribine Tablets or placebo). 2. Patients can give signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and this protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 920 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: Main study: Any condition, including 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. If a patient is experiencing a confirmed or suspected relapse at the time of screening, the Medical Monitor is to be consulted to agree on a stabilization period (estimated to be between 4 weeks and 3 months) before Study Visit 1. MRI-Substudy: a. Female study participants who are pregnant b. Patients were administered Cladribine Tablets through prescription or as part of another study within 6 months period before enrolment in the MRI Sub-study (i.e. patients participating in a clinical trial or observational study within the 6 month period before enrolment in the MRI Sub-study, but do not receive Cladribine Tablets as part of these studies, are allowed to participate in the sub-study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To assess the long-term disability status after treatment with IMP as part of the Phase III ORACLE MS and CLARITY/CLARITY-EXT clinical trials for the CLARITY/CLARITY-EXT and ORACLE MS populations. 2. To evaluate differences in clinical characteristics between long-term responders and study participants requiring alternate therapies following treatment with IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations. MRI Sub-Study: 3. To evaluate differences in magnetic resonance imaging (MRI) characteristics between long-term responders and study participants requiring alternate therapies following treatment with IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.;Main Objective: To evaluate long-term mobility after treatment with an investigational medicinal product (IMP; Cladribine Tablets or placebo) as part of the Phase III ORACLE MS and CLARITY/CLARITY-EXT clinical trials.;Primary end point(s): Proportion of study participants using a wheelchair (defined as unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hours a day) the majority of the time in the 3 month prior to Study Visit 1 or participants are bedridden any time prior to Study Visit 1 determined via: • Expanded Disability Status Scale (EDSS) score of 7.0 or higher (if available), or • Alternative clinical description data in medical records.;Timepoint(s) of evaluation of this end point: Study visit 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of study participants with EDSS of 6.0 or higher as determined by EDSS documentation or alternative clinical description in medical records after last IMP from parent study. 2. Clinical characteristics of long-term responders (defined as study participants who did not demonstrate any evidence of disease reactivation based on Investigator assessment of clinical and imaging outcomes until Year 4 or later following their last dose of IMP and who did not receive disease modifying treatment until Year 4 or later following their last dose of IMP) compared to those of other study participants who started on alternate therapy less than 4 years following their last dose of IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations. MRI Sub-Study: 3. MRI characteristicsc at Study Visit 2 of longterm responders (defined as study participants who did not demonstrate any evidence of disease reactivation based on Investigator assessment of clinical and imaging outcomes until Year 4 or later following their last dose of IMP and who did not receive disease modifying treatment until Year 4 or later following their last dose of IMP) compared to those of other study participants who started on alternate therapy less than 4 years following their last dose of IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.;Timepoint(s) of evaluation of this end point: ad 1. Study Visit 1 ad 2. Study Visit 1 ad 3. Study visit 2 | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Estonia, Finland, France, Georgia, Germany, Italy, Korea, Republic of, Lebanon, Lithuania, Morocco, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Spain, Sweden, Switzerland, Tunisia, Ukraine, United Kingdom, United States
Contacts
Public ContactCommunication Center Merck KGaA
Merck KGaA
Outcome results
None listed