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

This study has been completed.
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00472797
First received: May 10, 2007
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Relapsing Multiple Sclerosis
Drug: Rebif New Formulation Non Titrated
Drug: Rebif New Formulation Titrated
Phase 3

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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ) [ Time Frame: % change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The MSTCQ Global Side Effect domain assesses the subjects degree of satisfaction on global side effect questions 9, 10 & 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied).

  • Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    The MSTCQ in all domains assesses quality of life. The score for all domains other than the Global Side Effect ranges from 17 (most favorable) to 85 (least favorable). Change calculated as (score at week 12 - score at baseline.

  • Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    The SF-MPQ assesses Tolerability of Pain with 15 questions to evaluate the type and severity of pain experienced 60 minutes after an injection of study drug. Scores range from 0 (no pain) to 45 (severe pain).

  • Tolerability in Pain Using Visual Analog Scale (VAS) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    The SF-MPQ included a visual analog scale, ranging from 0 to 100 mm, on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm). A rating of <5 mm was considered pain-free.

  • Tolerability - Redness at Injection Site [ Time Frame: Baseline to Week 12 (LOCF) ] [ Designated as safety issue: No ]
    Change in Baseline to Week 12 Last Observation Carried Forward(LOCF)- A blinded assessment of injection site redness was conducted by a health care professional (1-72 hours) after the most recent injection measuring redness at its widest diameter in mm. Diameter of Redness, lower is better.


Other Outcome Measures:
  • SF-36 Physical and Mental Component Scores [ Time Frame: Change from Baseline to Each Visit ] [ Designated as safety issue: No ]
    Change from Baseline to each visit for Physical and Mental Component scores for SF-36. Score is norm-based with a mean of 50 and a standard deviation of 10.


Enrollment: 232
Study Start Date: April 2007
Study Completion Date: November 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Rebif New Formulation - Non Titrated
Drug: Rebif New Formulation Non Titrated
human interferon beta 1a - Rebif New Formulation
Active Comparator: 2
Rebif New Formulation - Titrated
Drug: Rebif New Formulation Titrated
Human interferon beta 1a Rebif New Formulation

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472797

Locations
United States, Massachusetts
EMD Serono, Inc.
Rockland, Massachusetts, United States, 02370
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Fernando Dangond, MD EMD Serono, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Ahmad Al-Sabbagh, Vice President Medical Affairs, US Neurology, EMD Serono, Inc
ClinicalTrials.gov Identifier: NCT00472797     History of Changes
Other Study ID Numbers: 27955
Study First Received: May 10, 2007
Results First Received: February 18, 2009
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration

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
Interferon-beta
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 28, 2014