Full Text View
Tabular View
Study Results
Related Studies
Rebif New Formulation (RNF) Quality of Life (QOL) Study (RebiQoL)
This study is ongoing, but not recruiting participants.
Study NCT00472797   Information provided by EMD Serono
First Received: May 10, 2007   Last Updated: September 9, 2009   History of Changes

May 10, 2007
September 9, 2009
April 2007
February 2009   (final data collection date for primary outcome measure)
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 primary endpoint is the relative % change in Global Side Effect score (i.e., a total score from MS Treatment Concerns Questionnaire Side Effect questions Q9, 10 & 11) at week 12 (RNF) compared to baseline (current Rebif) across all subjects [ Time Frame: Week 12 ]
Complete list of historical versions of study NCT00472797 on ClinicalTrials.gov Archive Site
  • 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 ]
Quality of Life and Tolerability [ Time Frame: Various timepoints ]
 
Rebif New Formulation (RNF) Quality of Life (QOL) Study
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)

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).

 
Phase III
Interventional
Supportive Care, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Relapsing Multiple Sclerosis
  • Drug: Rebif New Formulation Non Titrated
  • Drug: Rebif New Formulation Titrated
  • Active Comparator: Rebif New Formulation - Non Titrated
  • Active Comparator: Rebif New Formulation - Titrated
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
232
November 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00472797
Ahmad Al-Sabbagh, Vice President Medical Affairs, US Neurology, EMD Serono, Inc
27955
EMD Serono
 
Study Director: Fernando Dangond, MD EMD Serono, Inc.
EMD Serono
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP