Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants Who Have Participated in Cladribine Clinical Trials
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT01013350
- Lead Sponsor
- EMD Serono
- Brief Summary
Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants who Have Participated in Cladribine Clinical Trials
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1161
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Resolution of Lymphopenia, Among Registry Participants With Persistent Lymphopenia up to 3251 days Persistent lymphopenia was defined as Grade 3 (less than \[\<\] 500-200 per millimeter \[mm\] \^3 or \< 0.5-0.2 multiply \[\*\]10\^9 per Liter) or Grade 4 (\< 200/mm\^3 or \< 0.2\*10\^9 per Liter) lymphopenia as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The resolution is the achievement of a CTCAE Grade 1 (\< lower limit of normal \[LLN\] to 800 per mm\^3 or \< LLN to 0.8\*10\^9 per Liter) or Grade 0 (\< 910 per mm\^3 ) lymphocyte count. Persistent Lymphopenia was reported only in Cladribine group, hence results are reported only for "Exposed to Cladribine" arm. Time to resolution is reported.
Number of Participants With Adverse Events (AEs) in the "Blood and Lymphatic System Disorders" System Organ Class (SOC) and in the "Neoplasms Benign, Malignant, and Unspecified" SOC up to 3251 days An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug.
Number of Participants With Serious Adverse Drug Reactions (SADRs) up to 3251 days SADR is an adverse drug reaction that fulfils at least one of the seriousness criterion; results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is otherwise considered as medically important. An adverse drug reaction (ADR) is a response to a medicinal product which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the restoration, correction, or modification or physiological functions. Number of participants with SADRs were reported.
- Secondary Outcome Measures
Name Time Method Number of Participants With Pregnancy Outcomes up to 3251 days Pregnancies occurred among female participants exposed to cladribine were identified by a participant-reported positive pregnancy test and at least a 2-week delay in menses, or a participant-reported pregnancy diagnosed by a physician. Pregnancy outcomes were Live birth, Induced abortion (Termination), Spontaneous loss (Miscarriage) (\< 22 weeks), Foetal death (stillbirth) (\>=22 weeks), Ectopic pregnancy, Congenital malformations and others (unknown). Number of participants as per pregnancy outcome category were reported.
Trial Locations
- Locations (1)
Outcome Sciences, Inc
🇺🇸Cambridge, Massachusetts, United States