Transition to Rebif New Formulation | NCT00619307

NCT00619307

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transition with prophylactic ibuprofen	Active Comparator		Drug: Rebif New Formulation + prophylactic Ibuprofen
Transition with PRN ibuprofen	Active Comparator		Drug: Rebif New Formulation + ibuprofen PRN

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rebif New Formulation + prophylactic Ibuprofen	Drug	Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, receives systematically 400 mg ibuprofen as prophylactic treatment against flu-like symptoms on days when Rebif New Formulation 44 mcg three times a week is injected

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score	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.	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score	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.	4 weeks

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Sabine Latour, MD	Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Medical Information		Paris			France
Local Medical Information

Arm/Group Information

ID	Title	Description
FG000	Transition With Prophylactic Ibuprofen	subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection. Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.
FG001	Transition With PRN Ibuprofen	subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Transition With Prophylactic Ibuprofen	subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection. Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score

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.

ITT

Posted

Mean

95% Confidence Interval

MSTCQ score (units on a scale)

4 weeks

ID	Title	Description
OG000	Transition With Prophylactic Ibuprofen	subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection. Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Transition With Prophylactic Ibuprofen	subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection. Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals