Phase 3
N=117
Transition to Rebif New Formulation
Relapsing Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00619307 ↗Enrolled (actual)
117
Serious AEs
0.9%
Results posted
Jul 2010
Primary outcome: Primary: Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score — 8.5; 9.1 MSTCQ score (units on a scale)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rebif New Formulation + prophylactic Ibuprofen (Drug); Rebif New Formulation + ibuprofen PRN (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score |
8.5; 9.1 | — |
| SECONDARY Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score |
36.8; 38.3 | — |
| SECONDARY Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score |
14.3; 15.0 | — |
| SECONDARY Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score |
9.4; 9.2 | — |
| SECONDARY Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score |
4.7; 5.0 | — |
Summary
To assess patient satisfaction with respect to the incidence of flu-like symptoms (FLS) in patients with multiple sclerosis transitioned from current Rebif (subcutaneously injected interferon beta-1a, 44 mcg three-times-weekly) to the new formulation of Rebif (RNF) while receiving ibuprofen either prophylactically or only when necessary (PRN) after the occurence of flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
- Subject with relapsing forms of Multiple Sclerosis (MS)
- Expanded disability status scale (EDSS) score 1.5 times the upper limit of normal, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of the normal values.
- Subject has inadequate bone marrow reserve, defined as a total white blood cell count < 3.0 x 109/L, platelet count < 75 x 109/L, haemoglobin < 100 g/L.
- Subject suffers from an active autoimmune disease other than MS
- Subject suffers from major medical or psychiatric illness
- Subject has seizures history or is currently experiencing seizures not adequately controlled by anti-epileptics
- Subject is pregnant or attempting to conceive
- Visual or physical impairment that precludes completion of diaries and questionnaires by himself/herself
- Contraindication to ibuprofen: known hypersensitivity to the active ingredient ibuprofen
- Known hypersensitivity to non-steroidal anti-inflammatory drugs which can lead to asthmatic attacks, gastric and/or intestinal ulcers, gastro-intestinal bleeding, cerebro-vascular bleeding or other active bleeding, severe hepatic dysfunction, severe kidney dysfunction, severe cardiac insufficiency, or systemic lupus erythematosus
Data sourced from ClinicalTrials.gov (NCT00619307). 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.