Clinical trial NCT00472797: Rebif New Formulation (RNF) Quality of Life (QOL) Study
Official title: A Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Relapsing Multiple Sclerosis
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2007-05-14
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation of Rebif (RNF).


Eligibility criteria: Inclusion Criteria:

1. Subject with a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria
2. Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment
3. Subject currently using Rebiject II and 29 gauge needle
4. Subject is between 18 and 60 years old inclusive
5. Subject is able to read and understand English
6. Subject is willing to follow study procedures
7. Subject has given written informed consent and signed HIPAA
8. Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either: i) Being post-menopausal or surgically sterile, or ii) Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study. (Confirmation required within 30 days prior to start of the study)

Exclusion Criteria:

1. Use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. Receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's Rebif® therapy (e.g., receiving a influenza or pneumococcus vaccination) is acceptable
2. Subject receiving MS therapy in addition (i.e., combination therapy) to Rebif® within 3 months prior to study enrollment or at any time during study protocol.
3. Subjects who have previously been on Rebif New Formulation (RNF).
4. Subject with progressive forms of Multiple Sclerosis (MS).
5. Subject with history of any chronic pain syndrome.
6. Subject has any other disease apart from MS that could better explain the subjects signs and symptoms.
7. Subject has complete transverse myelitis or bilateral optic neuritis.
8. Subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1.
9. Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1 (prior to enrollment).
10. Subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase \> 2.5 times the upper limit of the normal values.
11. Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
12. Subject suffers from other current autoimmune disease.
13. Subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
14. Subject is pregnant or attempting to conceive
15. Visual or physical impairment that precludes completion of diaries and questionnaires.

Primary outcomes:
measure: Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)
timeFrame: % change from Baseline to Week 12
Secondary outcomes:
measure: Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
timeFrame: Baseline and Week 12
measure: Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
timeFrame: Baseline to Week 12
measure: Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12
timeFrame: Baseline to Week 12
measure: Tolerability in Pain Using Visual Analog Scale (VAS)
timeFrame: Baseline to Week 12
measure: Tolerability - Redness at Injection Site
timeFrame: Baseline to Week 12 (LOCF)
Other outcomes:
measure: SF-36 Physical and Mental Component Scores
timeFrame: Change from Baseline to Each Visit
Locations:
city: Rockland
country: United States
facility: EMD Serono, Inc.
state: Massachusetts
Study officials:
affiliation: EMD Serono
name: Fernando Dangond, MD
role: STUDY_DIRECTOR
References: