Study for the satisfaction assessement of the treatment with Plegridy in patient with Multiple Sclerosis

Phase 1

• Conditions: Subjects with relapsing-remitting multiple sclerosis; MedDRA version: 19.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-002201-11-IT
• Lead Sponsor: BIOGEN IDEC ITALIA S.R.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-28
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

18 < Age < 65 years
RRMS as per 2010 McDonald criteria
Baseline EDSS between 0.0 and 5.0
Treatment with injectable subcutaneous Interferons with score < 58 in the convenience satisfaction” domain of TSQM-9
Signed informed consent
Period of stability from last relapse of at least 30 days before the baseline visit.
Treatment with intravenous corticosteroids completed at least 30 days before the baseline visit (assumption of oral cortisone allowed as long as within 4 mg per day for no longer than 3 days).

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 275
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy or breast-feeding
Depression or other psychiatric disorders
Unwillingness or inability to comply with the protocol requirements
Any contra-indications to treatment with Peg-IFN-beta 1a according to the Summary of Product Characteristics

Study & Design

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