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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01013350
Recruitment Status : Completed
First Posted : November 13, 2009
Results First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Tracking Information
First Submitted Date November 11, 2009
First Posted Date November 13, 2009
Results First Submitted Date October 24, 2019
Results First Posted Date November 15, 2019
Last Update Posted Date November 15, 2019
Actual Study Start Date November 30, 2009
Actual Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 24, 2019)
  • Number of Participants With Serious Adverse Drug Reactions (SADRs) [ Time Frame: 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.
  • Time to Resolution of Lymphopenia, Among Registry Participants With Persistent Lymphopenia [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: October 24, 2019)
Number of Participants With Pregnancy Outcomes [ Time Frame: 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants Who Have Participated in Cladribine Clinical Trials
Official Title Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Studies (PREMIERE)
Brief Summary Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants who Have Participated in Cladribine Clinical Trials
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with Multiple Sclerosis and had already participated in Sponsor oral cladribine clinical development trials
Condition Multiple Sclerosis
Intervention Not Provided
Study Groups/Cohorts
  • Never Exposed to Cladribine
    All participants who received placebo matched to cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826 , NCT00641537, NCT00938366 and NCT00725985).
  • Exposed to Cladribine
    All participants who received cladribine in previously conducted clinical trials (NCT Number: NCT00213135, NCT00436826, NCT00641537, NCT00938366 and NCT00725985).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 24, 2019)
1161
Original Estimated Enrollment
 (submitted: November 12, 2009)
1500
Actual Study Completion Date October 25, 2018
Actual Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Eligibility 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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01013350
Other Study ID Numbers EMR700568-012
2009-017978-21 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party EMD Serono
Study Sponsor EMD Serono
Collaborators Not Provided
Investigators
Study Director: Medical Responsible EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
PRS Account EMD Serono
Verification Date October 2019