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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by EMD Serono
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01013350
First received: November 11, 2009
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Multiple Sclerosis
Drug: Cladribine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Trials

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Number of subjects with serious adverse drug reactions (SADRs) [ Time Frame: Up to the end of the registry, which is planned for 2018, or 8 years after the subject's first enrolment into a cladribine clinical trial, whichever occurs first ] [ Designated as safety issue: Yes ]
  • Time to resolution of lymphopenia, among registry participants with persistent lymphopenia [ Time Frame: Up to the end of the registry, which is planned for 2018, or 8 years after the subject's first enrolment into a cladribine clinical trial, whichever occurs first ] [ Designated as safety issue: Yes ]
  • Number of subjects with all Adverse Events (AEs) in the "Blood and Lymphatic System Disorders" System Organ Class (SOC) and in the "Neoplasms Benign, Malignant, and Unspecified" SOC [ Time Frame: Up to the end of the registry, which is planned for 2018, or 8 years after the subject's first enrolment into a cladribine clinical trial, whichever occurs first ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pregnancy outcomes [ Time Frame: Up to the end of the registry, which is planned for 2018, or 8 years after the subject's first enrolment into a cladribine clinical trial, whichever occurs first ] [ Designated as safety issue: No ]

Estimated Enrollment: 1402
Study Start Date: November 2009
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cladribine
This is an observational study. Subjects who had already participated in the cladribine clinical trials will be observed.
Drug: Cladribine
This is an observational study. Subjects who had already participated in the cladribine clinical trials will be observed.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with Multiple Sclerosis and had already participated in Sponsor oral cladribine clinical development trials

Criteria

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:

  • Subjects who cannot be reached by telephone
  • Subjects unable to answer the registry questionnaires and who do not have a next of kin or caregiver able to answer the registry questionnaires
  • Subjects who - either during the lag interval or subsequently - enter an interventional study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013350

Contacts
Contact: US Medical Information 888-275-7376

Locations
United States, Massachusetts
Outcome Sciences, Inc Recruiting
Cambridge, Massachusetts, United States
Contact: Outcome Sciences, Inc Sciences, Inc    617-674-8421      
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Medical Responsible EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01013350     History of Changes
Other Study ID Numbers: EMR700568-012, 2009-017978-21
Study First Received: November 11, 2009
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
Multiple Sclerosis
Cladribine
PREMIERE
Observational study

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Cladribine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014