A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02064816
• Date of registration: 13/02/2014
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA, Darmstadt, Germany
• Public title: A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis RELIEF
• Scientific title: Multicenter, Open-label, 12 Week, Phase IV Prospective Randomized Study Aimed at Evaluating Whether sc IFN Beta 1a (Rebif®) Administered in the Morning May Affect the Severity of Flu-like Syndrome and Patient-perceived Invisible Symptoms in Subjects With Relapsing Multiple Sclerosis
• Date of first enrolment: May 31, 2014
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02064816
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Germany

Contacts

• Name: Medical Responsible
• Affiliation: Merck Serono S.P.A., Italy

Key inclusion & exclusion criteria

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 precludes the subjects from
self-injecting the treatment using RebiSmart®

- Subjects have hypersensitivity to natural or recombinant interferon, or to any of its
excipients

- Subjects have any contra-indications to treatment with interferon (IFN) beta 1a
according to Summary of Product Characteristics (SmPC)

- Subjects have any contra-indications to treatment with ibuprofen/paracetamol according
to SmPC

- Obese subjects, defined by body mass index greater than 30 kilogram per square meter
(kg/m^2)

- Subjects have participated in any other investigational trial within 30 days from
Baseline

- Subjects have any other significant disease that in the Investigator's opinion would
exclude the subject from the trial



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: Rebif®

Primary Outcome(s)

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 [Time Frame: Week 12]

Secondary Outcome(s)

Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQOL) Score at Week 4, 8 and 12 [Time Frame: Baseline, Week 4, 8 and 12]

Change From Baseline in Total Sleep Time (TST) and Rapid Eye Movement (REM) Sleep Time at Week 12 [Time Frame: Baseline and Week 12]

Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation [Time Frame: Baseline up to Week 12]

Change From Baseline in Cytokines (Leptin and Resistin) Levels at Week 12 [Time Frame: Baseline and Week 12]

Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Subscale Scores Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 4, 8 and 12 [Time Frame: Week 4, 8 and 12]

Change From Baseline in Circulating Levels of Cytokines at Week 12 [Time Frame: Baseline and Week 12]

Correlation Between Change From Baseline in Circulating Levels of Cytokines (Leptin, Resistin and Adiponectin) and in Flu Like Symptom (FLS) Score at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 4, 8 and 12 [Time Frame: Baseline, Week 4, 8 and 12]

Change From Baseline in Cytokine (Adiponectin) Level at Week 12 [Time Frame: Baseline and Week 12]

Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 4, 8 and 12 [Time Frame: Baseline, Week 4, 8 and 12]

Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 4 and 8 [Time Frame: Week 4 and 8]

Correlation Between Change From Baseline in Cytokines (Leptin, Resistin and Adiponectin) and Hormone-like Cytokine Levels (Interleukin-6, 10 and 12), and TST and REM Sleep Time at Week 12 [Time Frame: Baseline and Week 12]

Correlation Between Change From Baseline in Circulating Levels of Cytokines and in Other MSTCQ Items, HADS, FSS, PSQI and MusiQOL Scores at Week 12 [Time Frame: Baseline and Week 12]

Percentage of Subjects With Treatment Adherence at Week 4, 8 and 12 [Time Frame: Week 4, 8 and 12]

Change From Baseline in Fatigue Severity Scale (FSS) Score at Week 4, 8 and 12 [Time Frame: Baseline, Week 4, 8 and 12]

Change From Baseline in Hormone-Like Cytokine (Interleukin-6, 10 and 12) Levels at Week 12 [Time Frame: Baseline and Week 12]

Secondary ID(s)

2013-004450-21

200136-570

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/09/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02064816