A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF

Phase 1

• Conditions: Relapsing multiple sclerosis; MedDRA version: 9.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosis

• Registration Number: EUCTR2006-005972-42-FR
• Lead Sponsor: Merck Serono International SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-05
• Study Completion: 2008-05-23
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Subject with Relapsing Forms of MS (RMS)
EDSS score <- (equal or less than) 5.5 at study entry
Subjects who have been administering Rebif 44mcg tiw for at least 6 months prior to study enrolment·
Subject currently using Rebiject II and who will use own Rebiject II for the RNF injections
Subject is between 18 and 60 years old inclusive
Female subjects must be neither pregnant nor breast-feeding and must lack childbearing potential, as defined by either: Post-menopausal or surgically sterile, or Using a highly effective method of contraception. A highly effective method of contraception is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs (intrauterine devices), sexual abstinence or vasectomised partner.
Subject is willing to follow study procedures
Subject is willing and must not present any contra-indication to taking ibuprofen during 4 weeks
Subject has given written informed consent.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Secondary Progressive Multiple Sclerosis (SPMS) without superimposed attacks
Use of any other injectible medications during the week prior to the screening period, during the screening or treatment periods
Subject receiving MS therapy in addition (i.e. combination therapy) to Rebif within 3 months prior to study enrolment or at any time during study protocol·
History of any chronic pain syndrome
Subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1
Subject received corticosteroids or ACTH within 30 days of visit 1
Subject with flu-like symptoms associated with any cause (i.e. no current flu and no FLS related to Interferon in the week prior to baseline)
Subject has abnormal liver function, defined by a total bilirubin > 1.5 times the upper limit of normal, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of the normal values
Subject has inadequate bone marrow reserve, defined as a total white blood cell count < 3.0 x 109/L, platelet count < 75 x 109/L, haemoglobin < 100 g/L.
Subject suffers from an active autoimmune disease other than MS.
Subject suffers from major medical or psychiatric illness (including current, severe disorders and/or suicidal ideation) that in the opinion of the investigator could affect compliance with the study protocol
Subject is pregnant or attempting to conceive
Visual or physical impairment that precludes completion of diaries and questionnaires by himself/herself
Contraindication to ibuprofen.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To obtain clinical experience with the transition to RNF in order to provide physicians with recommendations how to best manage this transition through the use of concomitant ibuprofen.;Primary end point(s): The primary endpoint is the FLS score from the MSTCQ at week 4. This is defined as the sum of the scores for side effects” section questions 1-4, corresponding to a maximum total score of 20.;Main Objective: To assess subject satisfaction by the MS Treatment Concern Questionnaire (MSTCQ) specifically measuring Flu Like Symptoms (FLS) during the first 4 weeks after subjects transitioned to RNF in 2 treatment groups: one treatment group receives ibuprofen prophylactically and the other ibuprofen PRN.