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

Bayer

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis, Relapsing-Remitting

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00459667

309363 (Other Identifier)

91656

2006-005270-47 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,420 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,420 participants in 3 patient groups

IFNB-1b 500 mcg

Experimental group

Description:

Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind)

Treatment:

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

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

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

IFNB-1b 250 mcg

Experimental group

Description:

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

Treatment:

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

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

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

IFNB-1b 250 mcg*

Experimental group

Description:

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.)

Treatment:

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

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

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