Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania using Electronic Device RebiSmart™

Phase 1

• Conditions: Clinical isolated syndrome and relapse multiple sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-001290-14-RO
• Lead Sponsor: MERCK ROMANIA SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-27
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Males and females between 18 to 65 years of age
Female patients must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined by either:
Post-menopausal or surgically sterile, or
Using a highly effective method of contraception for the duration of the study. This is defined as a method that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD), sexual abstinence or vasectomized partner.
Patients diagnosed with clinical isolated syndrome (CIS) or relapsing MS (RMS) according to the revised McDonald Criteria (2010).
MS-treatment naïve patients or patients treated with Rebif® multi-dose injected by RebiSmart™ for no longer than 6 weeks prior to Baseline visit
Patients that are able to self-inject with RebiSmart™ (in the opinion of the physician)
Patients with Expanded Disability Status Scale (EDSS) score < 6 (inclusive) at Baseline
Informed consent and patient data collection form signed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients experiencing a relapse within 30 days before Baseline
Participation in other studies within 30 days before Baseline
Received any MS therapy within 6 months prior to study enrolment (e.g., other disease modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of Rebif® multi-dose injected by RebiSmart™.
Any visual or physical impairment that precludes the patient from self-injecting the treatment using the RebiSmart™
Pregnancy and breast-feeding
Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure.
Current or past (within the last 2 years) history of alcohol or drug abuse.
Have any contraindications to treatment with interferon beta-1a according to Summary of Product Characteristics

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified