Transition to Rebif New Formulation

Relapsing Multiple Sclerosis Clinical Trial

— TRANSFER  

Official title:

A Randomized, Multicenter, Two-arm, Open-label, Phase IIIb Study to Evaluate the Satisfaction in Relapsing Multiple Sclerosis Subjects Transitioning to Rebif® New Formulation From Rebif® (Interferon Beta-1a) With Ibuprofen When Necessary (PRN) or as Prophylaxis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619307
• Other study ID #: 27571
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2008
• Last updated: January 26, 2014
• Start date: July 2007
• Est. completion date: April 2008

Study information

• Verified date: January 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Rebif New Formulation + prophylactic Ibuprofen
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
• Rebif New Formulation + ibuprofen PRN
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, should not administer Ibuprofen before the first Rebif New Formulation injection. If flu-like symptoms occur after the 44 mcg Rebif New Formulation injection then the subject can administer 400 mg ibuprofen. This should only be administered after the Rebif New Formulation injection and not before the Rebif New Formulation injection.

Locations

Country	Name	City	State
France	Local Medical Information	Paris
Germany	Local Medical Information	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	4 weeks	No
Secondary	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	No
Secondary	Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score	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.	4 weeks	No
Secondary	Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score	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.	4 weeks	Yes
Secondary	Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score	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.	4 weeks	Yes