| 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
|
| |
| |
| Active, not recruiting |
| 232 |
| November 2009 |
| February 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
|
| 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 |