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Phase 3 N=232 Randomized Supportive Care

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

Relapsing Multiple Sclerosis

Enrolled (actual)
232
Serious AEs
6.9%
Results posted
Sep 2009
Primary outcome: Primary: Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ) — 5.0 percent change — p=<0.001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Rebif New Formulation Non Titrated (Drug); Rebif New Formulation Titrated (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
EMD Serono
Primary completion
Feb 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)
5.0 <0.001 sig
SECONDARY
Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
13.4; 13.4; 13.4; 14.0; 13.8; 13.9 0.466
SECONDARY
Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
-3.2; -2.9; -3.1; -3.3; -2.3; -2.8 <0.001 sig
SECONDARY
Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12
0.7; 1.1; 0.9 0.302
SECONDARY
Tolerability in Pain Using Visual Analog Scale (VAS)
51; 48; 101; 53; 48; 101
SECONDARY
Tolerability - Redness at Injection Site
-2.3; -3.1; -2.7 0.899

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).

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00472797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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