Transition to Rebif New Formulation - Full Text View

Sponsored by:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00619307

Purpose

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

Condition	Intervention	Phase
Relapsing Multiple Sclerosis	Drug: Rebif New Formulation + prophylactically Ibuprofen Drug: Rebif New Formulation + ibuprofen PRN	Phase III

MedlinePlus related topics: Flu Multiple Sclerosis

Drug Information available for: Ibuprofen Dexibuprofen Interferons Interferon beta Interferon-beta Interferon beta 1a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment
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 PRN or as Prophylaxis

Further study details as provided by EMD Serono:

Primary Outcome Measures:

Patient Satisfaction [ Time Frame: Over the course of the study ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	June 2007
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Rebif New Formulation + prophylactically Ibuprofen Subject receives systematically 400mg ibuprofen as prophylactic treatment against flu-like symptoms on days when Rebif New Formulation 44mcg tiw is injected (3 times weekly)
2: Active Comparator	Drug: Rebif New Formulation + ibuprofen PRN Subjects should not administer Ibuprofen before the first Rebif New Formulation injection. If flu-like symptoms occur after the 44mcg 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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject with relapsing forms of Multiple Sclerosis
EDSS score < 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 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 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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619307

Locations

France
Local Medical Information
Paris, France
Germany
Local Medical Information
Munich, Germany

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Sabine Latoure, MD

Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany

More Information

Responsible Party:	EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany ( Liz Gedney, Clinical Trial Leader )
Study ID Numbers:	27571
Study First Received:	February 8, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00619307
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Ibuprofen
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferons
Interferon beta 1a

Interferon-beta
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Cyclooxygenase Inhibitors
Nervous System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Enzyme Inhibitors

Pharmacologic Actions
Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009