Transition to Rebif New Formulation - Full Text View

Sponsor:	Merck KGaA
Information provided by (Responsible Party):	Merck KGaA
ClinicalTrials.gov Identifier:	NCT00619307

Purpose

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.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
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

Resource links provided by NLM:

MedlinePlus related topics: Flu Multiple Sclerosis

Drug Information available for: Ibuprofen Interferon beta Interferon beta 1a

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:

Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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:

Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
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.

Enrollment:	117
Study Start Date:	July 2007
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Transition with prophylactic ibuprofen	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
Active Comparator: Transition with PRN ibuprofen	Drug: 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.

Arms

Assigned Interventions

Active Comparator: Transition with prophylactic ibuprofen

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

Active Comparator: Transition with PRN ibuprofen

Drug: 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.

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 (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

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

Merck KGaA

Investigators

Study Director:

Sabine Latour, MD

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

More Information

No publications provided

Responsible Party:	Merck KGaA
ClinicalTrials.gov Identifier:	NCT00619307 History of Changes
Other Study ID Numbers:	27571
Study First Received:	February 8, 2008
Results First Received:	May 11, 2010
Last Updated:	September 27, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Ibuprofen
Interferon beta 1a
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Adjuvants, Immunologic
Immunologic Factors
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012