A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis (NCT02064816) | Clinical Trial Compass
CompletedPhase 4
A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis
Germany200 participantsStarted 2014-05-31
Plain-language summary
This is an open-label, multi-center, 12-week, randomized, controlled, parallel group, Phase 4 study to assess whether the morning administration of interferon beta 1a (Rebif®) leads to a lower severity of flu-like symptoms (FLS) as compared to the evening administration, in subjects with relapsing multiple sclerosis (RMS).
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males and females between 18 and 60 years of age
* Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential. Furthermore, female subjects must not have been pregnant from at least three months prior to enter in the study
* Subjects have RMS according to the revised McDonald Criteria (2010)
* Subjects with an expanded disability status scale (EDSS) score of less than 6.0
* Subjects naive to treatment and eligible for treatment with Rebif® 44 three times a week, or patients having received glatiramer acetate with a wash-out from at least one month, or patients having received treatment with natalizumab or fingolimod with a wash-out from at least three months
* Subjects able to self-inject treatment using RebiSmart®
* Subjects willing and able to comply with the protocol for the duration of the study
* Subjects have given written informed consent to take part in the study
Exclusion Criteria:
* Subjects have any disease other than MS that could better explain his/her signs and symptoms
* Subjects who have received any immunosuppressive agents within 3 months prior to Baseline
* Subjects who have received any corticosteroids within 30 days prior to Baseline
* Subjects have a MS relapse within 30 days prior to Baseline
* Subjects have inadequate liver function and bone marrow reserve as defined in the protocol
* Subjects have moderate to severe renal impairment
* Subjects have any visual or physical impairment that p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 12