Transition to Rebif New Formulation

NCT00619307 | Completed Phase 3 Results

• 1 other identifier: 27571
• Study Type: interventional
• Target: 117
• Locations: 2 countries
• Sites: 2

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, 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.

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score

  4 weeks

• Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score

  4 weeks

• Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score

  4 weeks

• Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score

  4 weeks

Study Arms (2)

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

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

Transition with prophylactic ibuprofen

Rebif New Formulation + ibuprofen PRN 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, 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.

Transition with PRN ibuprofen

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (2)

Local Medical Information

Paris, France

Location

Local Medical Information

Munich, Germany

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Sabine Latour, MD

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 20, 2008
• Study Start: July 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 27, 2014
• Results First Posted: July 26, 2010

Record last verified: 2014-01

Locations

FR (1); DE (1)