ong-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials

Phase 1

• Conditions: Multiple Sclerosis patients who have participated in cladribine tablets clinical trials; MedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 14.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2009-017978-21-IT
• Lead Sponsor: MERCK SERONO SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-05
• Study Completion: 2018-10-25
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1148

Inclusion Criteria

The registry target population includes all subjects who participated in Sponsor oral cladribine phase I to III clinical trials in MS associated with a protocol approved prior to the time of submission of the marketing application and completed (last patient, last visit) after November 2008. XML File Identifier: 2r7kDP+G9TszIeNWeAN1vV8IpU8= Page 11/22 All subjects in the target population will be eligible for enrollment in the registry once their participation in the clinical trial has ended. Both the following inclusion criteria must be fulfilled: • Prior enrollment into selected clinical trials of the cladribine development program as described in section 5.1 regardless of randomization to either IMP or placebo, once participation in the clinical trial or in the clinical trial extension has ended • Written informed consent was given
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2175
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The following two reasons will exclude subjects from registry participation: • Subjects who cannot be reached by phone, or; • Subjects unable to answer the registry questionnaires and who do not have a next of kin or caregiver able to answer the registry questionnaires

Study & Design

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