Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Trials - Full Text View

Sponsor:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT01013350

Purpose

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

Condition
Multiple Sclerosis

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:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Cladribine

U.S. FDA Resources

Further study details as provided by EMD Serono:

Estimated Enrollment:	1500
Study Start Date:	November 2009
Estimated Primary Completion Date:	December 2018 (Final data collection date for primary outcome measure)

Detailed Description:

Primary Outcome Measures:

To produce long-term safety data on Oral CLADRIBINE in MS by estimating the frequency and risk factors for defined study events over a long period of time extending beyond Oral CLADRIBINE exposure, in a population of subjects who have been exposed to Oral CLADRIBINE in MS clinical studies.

Timeframe for taking Measurements: When 2 years of follow up data is available for 1000 subjects after registry enrollment.

Does this assess a particular Safety Issues? : Yes

Secondary Outcome Measures:

To explore the occurrence of selected and severe infections, malignancies, deaths, MDS, hematological toxicity, and pregnancies and pregnancy outcomes in relation to the cumulative dose and length of exposure to cladribine. The potential impact of other cladribine use patterns (i.e., recentness of use as current, recent, past) will be assessed through exploratory analysis.

Timeframe for taking Measurements: When 2 years of follow up data is available for 1000 subjects after registry enrollment.

Does this assess a particular Safety Issue? : Yes

Eligibility

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

Study Population

Patients who participated in Sponsor oral cladribine clinical development trials in Multiple Sclerosis.

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

Contacts and Locations

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

Contacts

Contact: Outcome Sciences, Inc

617-674-8421

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:

Montserrat Miret, MD, MPH

Merck Serono S.A., Geneva

More Information

No publications provided

Responsible Party:	Carol Marsella, Clinical Trial Leader, Merck Serono S.A.-Geneva, an Affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier:	NCT01013350 History of Changes
Other Study ID Numbers:	EMR700568-012
Study First Received:	November 11, 2009
Last Updated:	July 22, 2011
Health Authority:	United States: Food and Drug Administration

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 May 23, 2012