The overall objective of this trial is to provide additional data on the factors influencing IFN-beta response.Primary· To analyze the association between single nucleotide polymorphisms (SNP) markers and Rebif and Copaxone treatment response.…
ID
Source
Brief title
Condition
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To analyze the association between single nucleotide polymorphisms (SNP)
markers and Rebif and Copaxone treatment response.
Treatment response is based on EDSS progression and relapse outcomes over the
96 weeks of treatment in the REGARD trial.
Secondary outcome
To analyze the association between genetic markers with responses to treatment
for efficacy, safety and immunogenicity parameters.
Background summary
This is a Phase IV, interventional, multinational, multicenter, single blood
sampling exploratory pharmacogenetic study involving subjects who previously
participated in the REGARD trial and who did not participate in the initial PGx
substudy. The estimated duration of the recruitment period is 7 months.
Study objective
The overall objective of this trial is to provide additional data on the
factors influencing IFN-beta response.
Primary
· To analyze the association between single nucleotide polymorphisms (SNP)
markers and Rebif and Copaxone treatment response. Treatment response is based
on EDSS progression and relapse outcomes over the 96 weeks of treatment in the
REGARD trial.
Secondary
· To analyze the association between genetic markers with responses to
treatment for efficacy, safety and immunogenicity parameters.
Study design
This trial will consist of a single visit. Eligible subjects will be identified
and invited to participate in the trial either proactively or during a routine
clinic visit. If the subject consents, a single blood sample will be collected
for analysis of genetic markers .
For safety reasons, subjects will be kept under observation for 30 minutes
after blood sampling has been performed.
Intervention
There is only one visit with one blood drawn
Study burden and risks
During this single blood sampling, the needle sticks may cause local pain,
bruising, swelling, lightheadedness, dizziness and rarely, fainting and/or a
possible infection from the needle stick.
Tupolevlaan 41-61
1119 NW Schiphol-Rijk
NL
Tupolevlaan 41-61
1119 NW Schiphol-Rijk
NL
Listed location countries
Age
Inclusion criteria
Randomized patients from the REGARD 24735 study
Exclusion criteria
Patient who where already included in the initial REGARD PGx sub-study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01034579 |
| CCMO | NL30060.029.09 |