BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose (Beyond)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00459667
First received: April 11, 2007
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Flu-like-syndrome [ Time Frame: 309 days ] [ Designated as safety issue: Yes ]
    The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.

  • Injection-site Reactions [ Time Frame: 309 days ] [ Designated as safety issue: Yes ]
    The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.

  • Liver Enzyme Elevations [ Time Frame: 309 days ] [ Designated as safety issue: Yes ]
    The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.

  • Hematological Abnormalities [ Time Frame: 309 days ] [ Designated as safety issue: Yes ]
    The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.


Secondary Outcome Measures:
  • Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values [ Time Frame: 309 days ] [ Designated as safety issue: No ]
    Serum samples of about 8 mL for analysis of neutralizing antibodies (NAbs) to interferon (IFN) beta-1b were drawn at Baseline, Week 26 and the EOS visit.


Enrollment: 1420
Study Start Date: May 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IFNB-1b 500 mcg
Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
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).
Experimental: IFNB-1b 250 mcg
Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
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).
Experimental: IFNB-1b 250 mcg*

Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day

*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)

Drug: Interferon beta-1b (Betaseron, BAY86-5046)

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).


Detailed Description:

Phase A (3 arm parallel group): All patients randomized during the BEYOND study (Bayer 306440) to either IFNB 1b group (250µg or 500µg) will continue their previously assigned study medication, applying the same level of blinding as during the BEYOND study, All patients randomized during the BEYOND study to Copaxone and all patients with premature discontinuation of study medication during the BEYOND study will receive open-label IFNB 1b 250µg.

Phase B (single arm): All patients will receive open-label IFNB 1b 500µg)

Randomization: No randomization in this trial, patient's allocation in this follow-up study depends only on prior trial groups. The preceding study was randomized.

The trial is sponsored by Bayer Schering Pharma AG, Germany, Bayer HealthCare and Bayer HealthCare Pharmaceuticals Inc.

Secondary outcome measure "Assessment of patient-reported outcomes (FAMS and EQ 5D: The variables FAMS and EQ-5D were not analyzed due to the termination of the study before start of Phase B.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of the BEYOND study 306440 as scheduled
  • Relapsing multiple sclerosis
  • Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.
  • Females of child-bearing potential:

    • Agreement to practice adequate contraception methods and
    • Negative pregnancy test and
    • No lactation
  • Written informed consent

Exclusion Criteria:

  • Serious or acute heart diseases
  • History of severe depression or suicide attempt
  • Epilepsy not adequately controlled by treatment
  • Known allergy to IFNs, to human albumin or to mannitol
  • Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459667

  Show 184 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00459667     History of Changes
Other Study ID Numbers: 91656, 2006-005270-47, 309363
Study First Received: April 11, 2007
Results First Received: March 16, 2009
Last Updated: March 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Relapsing multiple sclerosis
interferon beta 1b
Betaferon
Betaseron

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on September 18, 2014