CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,420 enrolled
Drug / intervention
Interferon beta-1b (Betaseron, BAY86-5046) +2 moredrug
Likely dose
Interferon beta-1b (Betaseron/Betaferon) 500µg subcutaneously every other day (Phase B); 250µg or 500µg every other day (Phase A)AI-extracted
Key inclusion· 3
  • ✓Completion of the BEYOND study 306440 as scheduled
  • ✓Diagnosis of relapsing multiple sclerosis
  • ✓Medical assessment by investigator with no objection to participation based on experience from study 306440, particularly regarding laboratory abnormalities and liver, renal, or bone-marrow dysfunction
Key exclusion· 5
  • ✕Serious or acute heart diseases
  • ✕History of severe depression or suicide attempt
  • ✕Epilepsy not adequately controlled by treatment
  • ✕Known allergy to interferons, human albumin, or mannitol

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

Search/NCT00459667
NCT00459667Phase 3Completed
CompareCT.gov

International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg

Bayer·interventional·Posted Apr 12, 2007·Updated Apr 23, 2015

In Brief

A Phase 3 clinical trial evaluating Interferon beta-1b (Betaseron, BAY86-5046) for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 1,420 participants across 184 sites in 26 countries.

Detailed Summary

The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Relapsing-Remitting
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Russia, Slovenia, Spain, Sweden, Switzerland, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 12, 2007
Enrollment StartMay 1, 2007
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.2 years ago

Interventions

Interferon beta-1b (Betaseron, BAY86-5046)drug

Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).

Interferon beta-1b (Betaseron, BAY86-5046)drug

Phase A: 500ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).

Interferon beta-1b (Betaseron, BAY86-5046)drug

Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162. Phase B: All patients will receive 500µg s.c.every other day (open-label).