Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials

Phase 1

• Conditions: Multiple Sclerosis; MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-000069-19-CZ
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-07
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified