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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT01013350

EMR700568-012

2009-017978-21 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 1,161 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,161 participants in 2 patient groups

Never Exposed to Cladribine

Description:

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

Exposed to Cladribine

Description:

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