View Clinical Trial (Medical Research Study)
Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Trials
| City: |
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Cambridge |
| State: |
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Massachusetts |
| Zip Code: |
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| Conditions: |
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Multiple Sclerosis |
| Purpose: |
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Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients who Have
Participated in Cladribine Clinical Trials
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| Study Summary: |
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Primary Outcome Measures:
- Cumulative incidence of serious adverse drug reactions, including malignancies and
serious infections
- Time to resolution of lymphopenia, among registry participants with persistent
lymphopenia
- Cumulative incidence of all adverse events in the 'Blood and Lymphatic System
Disorders' and 'Neoplasms Benign, Malignant, and Unspecified' System Organ Classes
(SOCs).
Timeframe for taking Measurements: anticipated up to 8 years.
Does this assess a particular Safety Issues? : Yes
Secondary Outcome Measures:
Pregnancy outcomes, including congenital malformations, spontaneous abortion, elective
abortion, stillbirth, ectopic pregnancy, molar pregnancy, and other important health
conditions in the offspring.
Timeframe for taking Measurements: anticipated up to 8 years.
Does this assess a particular Safety Issue? : Yes
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| 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:
- 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.
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| NCT ID: |
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NCT01013350 |
| Primary Contact: |
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Study Director
Salima El Kebir El Kebir, MD
Merck Serono S.A., Geneva
Outcome Sciences, Inc
Phone: 617-674-8421
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| Backup Contact: |
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N/A |
| Location Contact: |
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Cambridge, Massachusetts
United States
Outcome Sciences, Inc Sciences, Inc
Phone: 617-674-8421
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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