Pharmacogenetic Trial and Long-term Follow-up of the PRIS... | NCT01034644

Studies
Pharmacogenetic Trial and Long-term Follow-up of the PRISMS Trial (PRISMS-15)

NCT01034644

Sponsor

Merck KGaA, Darmstadt, Germany

Status

Completed

Last Update Posted

Jul 31, 2014Estimated

Enrollment

290Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Dec 9, 2009

First Submission Date that Met QC Criteria

Dec 16, 2009

First Posted Date

Dec 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2014

Last Update Posted Date

Jul 31, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study, PRISMS-15 is a single visit, exploratory pharmacogenetic trial and long-term follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial.

The aim of this trial is to provide additional data on the driving factors of IFN beta response and the long-term outcomes of Rebif® treatment.

This is a Phase IV trial involving subjects who previously participated in the PRISMS trial. To address the trial objectives, a single visit will be performed, at least 3 months after the onset of the last relapse.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

290Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRISMS patients		This single group includes all the patients from the PRISMS study

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers		1 day

Secondary Outcomes

Measure	Description	Time Frame
Current course of MS: RRMS or SPMS		1 day
Current EDSS score		1 day
Change in EDSS since randomization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Was randomized in the PRISMS study
Is willing and able to comply with the protocol
Written informed consent given before any trial-related activities are carried out

Exclusion Criteria:

Is unwilling or unable to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Group of patients coming from the PRISMS 6789 study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elisabetta Verdun di Cantogno, MD	Merck Serono S.A., Geneva	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Please call/email Central Contact for Recruiting Information in		Geneva			Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33571946	Derived	Sormani MP, Freedman MS, Aldridge J, Marhardt K, Kappos L, De Stefano N. MAGNIMS score predicts long-term clinical disease activity-free status and confirmed disability progression in patients treated with subcutaneous interferon beta-1a. Mult Scler Relat Disord. 2021 Apr;49:102790. doi: 10.1016/j.msard.2021.102790. Epub 2021 Jan 22.

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases