Multiple SclerosisPRISMS-15NCT01034644
Pharmacogenetic Trial and Long-term Follow-up of the PRISMS Trial (PRISMS-15)
An observational study of Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 290 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2010to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group of patients coming from the PRISMS 6789 study
Who may be able to join
- 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
Who cannot join
- Is unwilling or unable to participate in the study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Please call/email Central Contact for Recruiting Information in
Geneva
About this study
Official 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
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
- Multiple Sclerosis
- Keywords
- Biomarkers, Genetic markers
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PRISMS patients | This single group includes all the patients from the PRISMS study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers
Measured: 1 day
Secondary outcomes (4)
Current course of MS: RRMS or SPMS
Measured: 1 day
Current EDSS score
Measured: 1 day
Change in EDSS since randomization
Measured: 1 day
Immunogenicity assessment
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startMar 2010
- Primary completionNov 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabetta Verdun di Cantogno, MD, Study director, Merck Serono S.A., Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034644
- Sponsor's protocol ID
- EMR200136_022
- Acronym
- PRISMS-15
- Status last verified
- Sep 2011
- First submitted
- 9 Dec 2009
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01034644
- Acronym / sponsor ID
- PRISMS-15 / EMR200136_022
- Conditions
- Multiple Sclerosis
- Keywords
- Biomarkers, Genetic markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRISMS patients | – | –This single group includes all the patients from the PRISMS study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group of patients coming from the PRISMS 6789 study
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Is unwilling or unable to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers
Time frame: 1 day
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
- Derived from this study: PubMed 33571946Sormani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabetta Verdun di Cantogno, MD study director
Merck Serono S.A., Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01034644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2014.