Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 1:09 AM
NCT ID:
NCT01110993
Eligibility Criteria:
There are no specific inclusion/exclusion criteria as the trial is a non-interventional, observational study. The criteria are based on SmPC and criteria of Polish National Found Programme of RRMS Patients Treatment:
Inclusion Criteria:
* Subjects aged above 18 years
* Subjects with clinically diagnosed RRMS which is characterised by two or more acute exacerbations in the previous two years
* Subjects who has never been treated with Rebif (previous treatment with other DMDs will not be regarded as an exclusion criterion)
* Written consent to cooperation made by the environmental nurse who takes care about subject in hospital as well as in his home
* Score of 21 or more points, according to National Heath Found Patient inclusion criteria for the 2 years program of MS treatment with interferon beta
Exclusion Criteria:
Exclusion criteria conform with Rebif's registered contraindications, described in an Sm PC approved by Ministry of Health.
* Interferon beta-1a is contraindicated during pregnancy
* Interferon beta-1a is contraindicated in subjects with confirmed hypersensitivity to natural or recombined interferon beta, or to any of the adjuvant substances
* Interferon beta-1a is contraindicated in subjects with severe depression and/or suicidal thoughts
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01110993
Study Brief:
Protocol Section:
NCT01110993