Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01013350




Registration number
NCT01013350
Ethics application status
Date submitted
11/11/2009
Date registered
13/11/2009
Date last updated
15/11/2019

Titles & IDs
Public title
Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants 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 Studies (PREMIERE)
Secondary ID [1] 0 0
2009-017978-21
Secondary ID [2] 0 0
EMR700568-012
Universal Trial Number (UTN)
Trial acronym
PREMIERE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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).
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Serious Adverse Drug Reactions (SADRs)
Timepoint [1] 0 0
up to 3251 days
Primary outcome [2] 0 0
Time to Resolution of Lymphopenia, Among Registry Participants With Persistent Lymphopenia
Timepoint [2] 0 0
up to 3251 days
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
up to 3251 days
Secondary outcome [1] 0 0
Number of Participants With Pregnancy Outcomes
Timepoint [1] 0 0
up to 3251 days

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2018
Sample size
Target
Accrual to date
Final
1161
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
EMD Serono
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants who
Have Participated in Cladribine Clinical Trials
Trial website
https://clinicaltrials.gov/ct2/show/NCT01013350
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries