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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 26 February 2018
Main ID:  EUCTR2009-017978-21-PT
Date of registration: 11/08/2011
Prospective Registration: Yes
Primary sponsor: Merck Serono S.A. - Geneva
Public title: Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials
Scientific title: Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry
Date of first enrolment: 06/07/2012
Target sample size: 2175
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017978-21
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Austria Belgium Bosnia and Herzegovina Brazil Bulgaria Canada
Croatia Czech Republic Denmark Estonia Finland France Georgia Germany
Greece India Italy Korea, Republic of Latvia Lebanon Lithuania Macedonia, the former Yugoslav Republic of
Morocco Netherlands Norway Poland Portugal Romania Russian Federation Saudi Arabia
Serbia Singapore Spain Sweden Switzerland Taiwan Thailand Tunisia
Turkey Ukraine United Arab Emirates United Kingdom United States
Contacts
Name: Communication Center Merck KGaA   
Address:  Frankfurter Strasse 250 64293 Darmstadt Germany
Telephone: + 49 6151 72 5200
Email: service@merckgroup.com
Affiliation:  Merck KGaA
Name: Communication Center Merck KGaA   
Address:  Frankfurter Strasse 250 64293 Darmstadt Germany
Telephone: + 49 6151 72 5200
Email: service@merckgroup.com
Affiliation:  Merck KGaA
Key inclusion & exclusion criteria
Inclusion criteria:
The registry target population includes all subjects who participated in Sponsor oral cladribine phase I to III clinical trials in MS associated with a protocol approved prior to the time of submission of the marketing application and completed (last patient, last visit) after November 2008.

All subjects in the target population described in section 5.1 will be eligible for enrollment in the registry once their participation in the clinical trial has ended. The following inclusion criteria must be fulfilled:
• Prior enrollment into selected clinical trials, regardless of randomization to either IMP or placebo, once participation in the clinical trial or in the clinical trial extension has ended
• Written informed consent is given.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion criteria:
The following reasons will exclude subjects from registry participation:
• Subjects who cannot be reached by phone;
• Subjects who are unable to answer the registry questionnaires and who do not have a next of kin or caregiver available to answer the registry questionnaires;
• Subjects who – either during the lag interval or subsequently – enter an interventional study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Product Name: Cladribine tablets
Product Code: Not applicable
Pharmaceutical Form: Tablet
INN or Proposed INN: Cladribine
CAS Number: 4291-63-8
Current Sponsor code: EMD280922
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)
Main Objective: The main purpose of the registry is to collect long-term safety data on oral cladribine in subjects with MS and to estimate the
frequency of serious adverse drug reactions (SADR) over a period of time, extending beyond cladribine exposure, in a population of subjects who have been exposed to oral cladribine. Subjects participating in selected Sponsor cladribine clinical trials in MS or in corresponding cladribine extension studies will be eligible for enrollment.
The focus will be on SADR (which include malignancies and serious infections), AEs in the ‘Blood and Lymphatic System Disorders’ and ‘Neoplasms Benign, Malignant, and Unspecified’ System Organ Classes (SOCs), pregnancies among exposed women and pregnancy outcomes, including congenital anomalies or other important health conditions in the offspring. Resolution of persistent lymphopenia will also be assessed among subjects with persistent lymphopenia.
Primary end point(s): • Cumulative incidence of serious adverse drug reactions (SADR), including malignancies and serious infections
• Time to resolution of lymphopenia, among registry participants with persistent lymphopenia
• Cumulative incidence of AE in the ‘Blood and Lymphatic System Disorders’ and ‘Neoplasms Benign, Malignant, and Unspecified’ System Organ Classes (SOCs).
Secondary Objective: • To quantify and characterize the risk (cumulative incidence) of SADR, including malignancies and serious infections
• To assess time to resolution of lymphopenia among registry participants with persistent lymphopenia;
• To quantify and characterize the risk (cumulative incidence) of AE in the ‘Blood and Lymphatic System Disorders’ and ‘Neoplasms Benign, Malignant, and Unspecified’ System Organ Classes (SOCs).

Secondary Objective
• To assess pregnancy outcomes, including congenital malformations or other important health conditions in the offspring born to women exposed to oral cladribine.
Secondary Outcome(s)
Secondary end point(s): • Pregnancy outcomes, including congenital malformations, spontaneous abortion, elective abortion, stillbirth, ectopic pregnancy, molar pregnancy, and other important health conditions in the offspring.
Secondary ID(s)
2009-017978-21-DE
EMR700568-012
NCT01013350
Source(s) of Monetary Support
Merck Serono S.A. - Geneva
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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