Rebif New Formulation (RNF) Quality of Life (QOL) Study

NCT00472797 | Completed Phase 3 Results

• 1 other identifier: 27955
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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).

Conditions

Relapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)

  The MSTCQ Global Side Effect domain assesses the degree of satisfaction on global side effect questions 9, 10 \& 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied). Percent change calculated as 100% \* (score at week 12 - score at baseline) / score at baseline.

  % change from Baseline to Week 12

Secondary Outcomes (5)

• Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)

  Baseline and Week 12

• Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)

  Baseline to Week 12

• Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12

  Baseline to Week 12

• Tolerability in Pain Using Visual Analog Scale (VAS)

  Baseline to Week 12

• Tolerability - Redness at Injection Site

  Baseline to Week 12 (LOCF)

Other Outcomes (1)

• SF-36 Physical and Mental Component Scores

  Change from Baseline to Each Visit

Study Arms (2)

1

ACTIVE COMPARATOR

Rebif New Formulation - Non Titrated

Drug: Rebif New Formulation Non Titrated

2

ACTIVE COMPARATOR

Rebif New Formulation - Titrated

Drug: Rebif New Formulation Titrated

Interventions

Rebif New Formulation Non Titrated DRUG

human interferon beta 1a - Rebif New Formulation

1

Rebif New Formulation Titrated DRUG

Human interferon beta 1a Rebif New Formulation

2

Eligibility Criteria

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

You may qualify if:

• Subject with a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria
• Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment
• Subject currently using Rebiject II and 29 gauge needle
• Subject is between 18 and 60 years old inclusive
• Subject is able to read and understand English
• Subject is willing to follow study procedures
• Subject has given written informed consent and signed HIPAA
• 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)

You may not qualify if:

• 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
• 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.
• Subjects who have previously been on Rebif New Formulation (RNF).
• Subject with progressive forms of Multiple Sclerosis (MS).
• Subject with history of any chronic pain syndrome.
• Subject has any other disease apart from MS that could better explain the subjects signs and symptoms.
• Subject has complete transverse myelitis or bilateral optic neuritis.
• Subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1.
• Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1 (prior to enrollment).
• 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.
• Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
• Subject suffers from other current autoimmune disease.
• 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
• Subject is pregnant or attempting to conceive
• Visual or physical impairment that precludes completion of diaries and questionnaires.

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (1)

EMD Serono, Inc.

Rockland, Massachusetts, 02370, United States

Location

Related Links

• Full FDA approved prescribing information can be found here

Results Point of Contact

• Title: Fernando Dangond, MD
• Organization: EMD Serono, INc.

fernando.dangond@emdserono.com

781 681 2348

Study Officials

• Fernando Dangond, MD

  EMD Serono

  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

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 14, 2007
• Study Start: April 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 7, 2013
• Results First Posted: September 2, 2009

Record last verified: 2013-08

Locations

US (1)