Transition to Rebif New Formulation

Phase 3

Completed

Conditions: Relapsing Multiple Sclerosis

Interventions: Drug: Rebif New Formulation + prophylactic Ibuprofen
Drug: Rebif New Formulation + ibuprofen PRN

Registration Number: NCT00619307

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary: To assess patient satisfaction with respect to the incidence of flu-like symptoms (FLS) in patients with multiple sclerosis transitioned from current Rebif (subcutaneously injected interferon beta-1a, 44 mcg three-times-weekly) to the new formulation of Rebif (RNF) while receiving ibuprofen either prophylactically or only when necessary (PRN) after the occurence of flu-like symptoms.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 117

Inclusion Criteria

Subject with relapsing forms of Multiple Sclerosis (MS)
Expanded disability status scale (EDSS) score < 5.5 at study entry
Subjects who have been administering Rebif 44 mcg three times a week for at least 6 months prior to study enrolment
Subject currently using Rebiject II and who will use their own Rebiject II for the Rebif New Formulation 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 use a highly effective method of contraception.
Subject is willing to follow study procedures
Subject is willing and must not present any contra-indication to taking ibuprofen during 4 weeks of the study
Subject has given written informed consent

Exclusion Criteria

Secondary Progressive Multiple Sclerosis 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
Subject received corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days of visit 1
Subject with flu-like symptoms (FLS) 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) > 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
Subject has seizures history or is currently experiencing seizures not adequately controlled by anti-epileptics
Subject is pregnant or attempting to conceive
Visual or physical impairment that precludes completion of diaries and questionnaires by himself/herself
Contraindication to ibuprofen:known hypersensitivity to the active ingredient ibuprofen
Known hypersensitivity to non-steroidal anti-inflammatory drugs which can lead to asthmatic attacks, gastric and/or intestinal ulcers, gastro-intestinal bleeding, cerebro-vascular bleeding or other active bleeding, severe hepatic dysfunction, severe kidney dysfunction, severe cardiac insufficiency, or systemic lupus erythematosus

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transition with prophylactic ibuprofen	Rebif New Formulation + prophylactic Ibuprofen	-
Transition with PRN ibuprofen	Rebif New Formulation + ibuprofen PRN	-

Primary Outcome Measures

Name	Time	Method
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score	4 weeks	This is defined as the sum of the scores for the "side effects" section questions 1-4, with a minimum possible total score of 1 and a maximum possible total score of 20 in the MSTCQ. The lower the score, the better the outcome.

Secondary Outcome Measures

Name	Time	Method
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score	4 weeks	This is defined as the sum of the scores for the "injection systems" section questions 1-9 and the "side effects" section questions 1-11, with a minimum possible total score of 20 and a maximum possible total score of 100. The lower the score, the better the outcome.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score	4 weeks	This is defined as the sum of the scores for the "injection systems" section questions 1-9, with a minimum possible total score of 9 and a maximum possible total score of 45. The lower the score, the better the outcome.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score	4 weeks	This is defined as the sum of the scores for the "side effects" section questions 5 to 8, with a minimum possible total score of 1 and a maximum possible total score of 20. The lower the score, the better the outcome.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score	4 weeks	This is defined as the sum of the scores for "side effects" section questions 9 to 11, corresponding to minimum possible total score of 3 and a maximum possible total score of 15. The lower the score, the better the outcome.