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

NCT01013350 | Completed Results

• 2 other identifiers: EMR700568-0122009-017978-21
• Study Type: observational
• Target: 1,161
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants who Have Participated in Cladribine Clinical Trials

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Cladribine; PREMIERE; Observational study

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Serious Adverse Drug Reactions (SADRs)

  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.

  up to 3251 days

• Time to Resolution of Lymphopenia, Among Registry Participants With Persistent Lymphopenia

  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.

  up to 3251 days

• 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

  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.

  up to 3251 days

Secondary Outcomes (1)

• Number of Participants With Pregnancy Outcomes

  up to 3251 days

Study Arms (2)

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Multiple Sclerosis and had already participated in Sponsor oral cladribine clinical development trials

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (1)

Outcome Sciences, Inc

Cambridge, Massachusetts, 02139, United States

Location

Related Publications (1)

• Giovannoni G, Galazka A, Schick R, Leist T, Comi G, Montalban X, Damian D, Dangond F, Cook S. Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety. Drug Saf. 2020 Jul;43(7):635-643. doi: 10.1007/s40264-020-00948-x.

  PMID: 32447743 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Communication Center
• Organization: Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2009
• First Posted: November 13, 2009
• Study Start: November 30, 2009
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: November 15, 2019
• Results First Posted: November 15, 2019

Record last verified: 2019-10

Locations

US (1)