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 range18 Years – 60 Years
SexALL
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…
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