Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants Who Have Participated in Cladribine Clinical Trials

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2018-10-25

Brief Summary

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Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants who Have Participated in Cladribine Clinical Trials

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Never Exposed to Cladribine

All participants who received placebo matched to cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826 , NCT00641537, NCT00938366 and NCT00725985).

No interventions assigned to this group

Exposed to Cladribine

All participants who received cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537, NCT00938366 and NCT00725985).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Prior enrollment into selected oral cladribine clinical trials as of randomization to either study drug or placebo, once participation in the clinical trial has ended
* Written informed consent was given

Exclusion Criteria

* Participants who cannot be reached by telephone
* Participants unable to answer the registry questionnaires and who do not have a next of kin or caregiver able to answer the registry questionnaires
* Participants who - either during the lag interval or subsequently enter an interventional study

Eligible Sex

ALL

Accepts Healthy Volunteers

No