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

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ClinicalTrials.gov Identifier: NCT01013350
Recruitment Status : Active, not recruiting
First Posted : November 13, 2009
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
EMD Serono

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

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Cladribine

Study Type : Observational
Actual Enrollment : 1183 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Trials
Actual Study Start Date : November 30, 2009
Estimated Primary Completion Date : October 26, 2018
Estimated Study Completion Date : October 26, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cladribine

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01013350


Locations
United States, Massachusetts
Outcome Sciences, Inc
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Medical Responsible EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01013350     History of Changes
Other Study ID Numbers: EMR700568-012
2009-017978-21 ( EudraCT Number )
First Posted: November 13, 2009    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: May 2018

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

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