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Rebif New Formulation (RNF) Quality of Life (QOL) Study (RebiQoL)
This study is ongoing, but not recruiting participants.
First Received: May 10, 2007   Last Updated: September 9, 2009   History of Changes
Sponsor: EMD Serono
Information provided by: EMD Serono
ClinicalTrials.gov Identifier: NCT00472797
  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 III

Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety 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)

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 ]

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 ]
  • 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 ]
  • 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 ]
  • Tolerability in Pain Using Visual Analog Scale (VAS) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Tolerability - Redness at Injection Site [ Time Frame: Baseline to Week 12 (LOCF) ] [ Designated as safety issue: No ]

Enrollment: 232
Study Start Date: April 2007
Estimated Study Completion Date: November 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Rebif New Formulation - Non Titrated
Drug: Rebif New Formulation Non Titrated
human interferon beta 1a - Rebif New Formulation
2: Active Comparator
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
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: EMD Serono, Inc ( Ahmad Al-Sabbagh, Vice President Medical Affairs, US Neurology )
Study ID Numbers: 27955
Study First Received: May 10, 2007
Results First Received: February 18, 2009
Last Updated: September 9, 2009
ClinicalTrials.gov Identifier: NCT00472797     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Infective Agents
Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Interferon-beta
Sclerosis
Antiviral Agents
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Interferon beta 1a
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on November 27, 2009