CompletedNCT01034644PRISMS-15Updated Jul 31, 2014

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

An observational study in Multiple Sclerosis, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-31.

Sponsored by Merck KGaA, Darmstadt, Germany · Observational

Study type: Observational
Time perspective: Retrospective
Enrollment: 290
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Multiple Sclerosis

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Keywords

Biomarkers
Genetic markers

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 290 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

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Lead sponsor

Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Group of patients coming from the PRISMS 6789 study

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

Exclusion Criteria:

Is unwilling or unable to participate in the study

Study design

Time perspective: Retrospective
Enrollment: 290 participants (actual)
Biospecimen retention: Samples with dna

Groups and cohorts

PRISMS patients
This single group includes all the patients from the PRISMS study

What researchers measure

Primary outcomes

The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers
Time frame: 1 day

Secondary outcomes

Current course of MS: RRMS or SPMS
Time frame: 1 day
Current EDSS score
Time frame: 1 day
Change in EDSS since randomization
Time frame: 1 day
Immunogenicity assessment
Time frame: 1 day

Study locations

1 site

Please call/email Central Contact for Recruiting Information in
Geneva, Switzerland

References and documents

Publications

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. PubMed 33571946 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01034644
Lead sponsor: Merck KGaA, Darmstadt, Germany
Responsible party: Sponsor
First posted: Dec 17, 2009
Start date: Mar 2010
Primary completion: Nov 2010
Completion: Jan 2011
Last update: Jul 31, 2014

Study contacts

Elisabetta Verdun di Cantogno, MD

study director · Merck Serono S.A., Geneva

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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