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Completed

NCT Number: NCT01034644

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Please call/email Central Contact for Recruiting Information in

Geneva, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers

    Time frame: 1 day

Secondary outcomes

  1. Current course of MS: RRMS or SPMS

    Time frame: 1 day

  2. Current EDSS score

    Time frame: 1 day

  3. Change in EDSS since randomization

    Time frame: 1 day

  4. Immunogenicity assessment

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

A Multinational, Multicenter, 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

Acronym: PRISMS-15

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Dec 17, 2009
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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