Status:
COMPLETED
Transition to Rebif New Formulation
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00619307
Start Date
July 1 2007
End Date
April 1 2008
Last Update
February 27 2014
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Medical Information
Paris, France
2
Local Medical Information
Munich, Germany