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A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: Rebif® (Drug); Rebif® (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Medical Responsible, Study Director, Affiliation: Merck Serono S.P.A., Italy

Overall contact:
Merck KGaA Communication Center, Phone: +49 6151 72 5200, Email: service@merckgroup.com

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).

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Flu-like Symptoms (FLS) score at Week 12

Secondary outcome:

Flu-like Symptoms (FLS) score at Weeks 4 and 8

Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Subscale scores at Weeks 4, 8 and 12

Change from Baseline in Hospital Anxiety and Depression Scale (HADS) subscale and total score at Weeks 4, 8 and 12

Change from Baseline in Fatigue Severity Scale (FSS) score at Weeks 4, 8 and 12

Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) score at Weeks 4, 8 and 12

Change from Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) score at Weeks 4, 8 and 12

Percentage of subjects with adherence to treatment

Change from Baseline in circulating levels of cytokines at Week 12

Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)

Correlation between change from Baseline in circulating levels of cytokines at Week 12 and FLS score

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Merck KGaA Communication Center, Phone: +49 6151 72 5200, Email: service@merckgroup.com

Please contact the Merck KGaA Communication Center, Darmstadt, Germany; Recruiting
Phone: +49 6151 72 5200, Email: service@merckgroup.com
Additional Information

Starting date: May 2014
Last updated: February 18, 2015

Page last updated: August 23, 2015

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