CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 129 enrolled
Drug / intervention
New Formulation of rebif - human interferon beta-1a +1 moredrug
Likely dose
New Formulation Rebif: 44 mcg SC thrice weekly; Betaseron: 250 mcg SC every other dayAI-extracted
Key inclusion· 4
  • ✓Diagnosis of relapsing-remitting MS (RRMS) per McDonald or Poser criteria
  • ✓Age 18-60 years inclusive
  • ✓Willing and able to provide written informed consent and follow study procedures
  • ✓For females: not pregnant/breastfeeding and either post-menopausal, surgically sterile, or using contraception (hormonal, IUD, diaphragm with spermicide, or condom with spermicide)
Key exclusion· 11
  • ✕Clinically Isolated Syndrome (CIS), Primary Progressive MS, or Secondary Progressive MS without superimposed relapses
  • ✕Prior interferon beta therapy (beta-1a or beta-1b)
  • ✕Other approved disease-modifying MS therapy (glatiramer acetate) or cytokine/anti-cytokine therapy within 3 months prior to Day 1
  • ✕Immunomodulatory or immunosuppressive therapy (cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, Campath, cladribine) within 12 months prior to Day 1

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00428584
NCT00428584Phase 3Completed
CompareCT.gov

A Randomized, Multicenter, Two Arm, Open Label, Twelve Week Phase IIIb Study to Evaluate the Tolerability of Rebif (New Formulation) (IFN Beta-1a) and Betaseron (IFN Beta-1b) in IFN-naive Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Followed by a Single Arm, Eighty-two Week Minimum, Rebif (New Formulation) Only Safety Extension

EMD Serono·interventional·Posted Jan 30, 2007·Updated Aug 7, 2013

In Brief

A Phase 3 clinical trial evaluating New Formulation of rebif - human interferon beta-1a and Interferon beta -1b for Relapsing Remitting Multiple Sclerosis (RRMS). Completed, enrolled 129 participants across 1 site.

Detailed Summary

To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site pain scores from pre-injection to 30 minutes post therapy administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Remitting Multiple Sclerosis (RRMS)
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2007
Enrollment StartDec 1, 2006
Primary CompletionNov 1, 2007
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.4 years ago

Interventions

New Formulation of rebif - human interferon beta-1adrug

New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection.

Interferon beta -1bdrug

Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection.