Trial · NCT00459667

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

NCT00459667, Phase 3, Completed, Bayer; results first posted 2009-08-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose. Trials, record NCT00459667. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00459667

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose
NCT number: NCT00459667
Status: Completed
Phases: Phase 3
Enrollment: 1,420 participants, actual
Lead sponsor: Bayer
Conditions: Multiple Sclerosis, Relapsing-Remitting
Interventions: Interferon beta-1b (Betaseron, BAY86-5046), Interferon beta-1b (Betaseron, BAY86-5046), Interferon beta-1b (Betaseron, BAY86-5046)
First posted: 2007-04-12
Last updated: 2015-04-23
Other registries' IDs: eudract:2006-005270-47
Results first posted: 2009-08-17
Limitations and caveats: Due to the termination of the study before start of Phase B according to protocol defined stopping rules, functional assessments of multiple sclerosis (FAMS) and EuroQoL (EQ-5D) were not performed.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Flu-like-syndrome	309 days	The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.
Primary	Injection-site Reactions	309 days	The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Primary	Liver Enzyme Elevations	309 days	The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Primary	Hematological Abnormalities	309 days	The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.
Secondary	Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values	309 days	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Flu-like-syndrome	309 days	The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Flu-Like-Syndrome with 95% confidence intervals were provided.	Percentage of participants	NUMBER
PRIMARY	Injection-site Reactions	309 days	The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of Injection-site reactions with 95% confidence intervals were provided.	Percentage of participants	NUMBER
PRIMARY	Liver Enzyme Elevations	309 days	The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of liver enzyme elevations were provided.	Percentage of participants	NUMBER
PRIMARY	Hematological Abnormalities	309 days	The analysis set used for safety analysis (SAF) comprised 1411 patients. AEs were defined as events with an onset date after the first application of study drug. The incidence rate of hematological abnormalities were provided.	Percentage of participants	NUMBER
SECONDARY	Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values	309 days	For the NAb analyses data were provided for 572 patients at Baseline, 238 at Week 26 and 1261 at EOS. The patients missing to the total number of 1411 patients had no data at the respective visits (table shows number of patients with positive titer in the extension treatment cohorts; the analyses provide frequencies of positive titers).	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group39

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Flu-like-syndrome	IFNB-1b 500 mcg		17.4	Percentage of participants
Flu-like-syndrome	IFNB-1b 250 mcg		15.8	Percentage of participants
Flu-like-syndrome	IFNB-1b 250 mcg*		31.1	Percentage of participants
Injection-site Reactions	IFNB-1b 500 mcg		31.7	Percentage of participants
Injection-site Reactions	IFNB-1b 250 mcg		26.2	Percentage of participants
Injection-site Reactions	IFNB-1b 250 mcg*		31.7	Percentage of participants
Liver Enzyme Elevations	IFNB-1b 500 mcg	GGT increased	2.7	Percentage of participants
Liver Enzyme Elevations	IFNB-1b 250 mcg	GGT increased	1.2	Percentage of participants
Liver Enzyme Elevations	IFNB-1b 250 mcg*	GGT increased	3.9	Percentage of participants
Liver Enzyme Elevations	IFNB-1b 500 mcg	AST increased	2.0	Percentage of participants

1 to 10 of 39Source ClinicalTrials.gov

See all 39 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	IFNB-1b 500 mcg	592
Overall Study	STARTED	IFNB-1b 250 mcg	647
Overall Study	STARTED	IFNB-1b 250 mcg*	181
Overall Study	Study Medication Dispensed	IFNB-1b 500 mcg	586
Overall Study	Study Medication Dispensed	IFNB-1b 250 mcg	645
Overall Study	Study Medication Dispensed	IFNB-1b 250 mcg*	180
Overall Study	Started Treatment	IFNB-1b 500 mcg	586
Overall Study	Started Treatment	IFNB-1b 250 mcg	644
Overall Study	Started Treatment	IFNB-1b 250 mcg*	180
Overall Study	COMPLETED	IFNB-1b 500 mcg	554

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events297

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Astenia	General disorders	IFNB-1b 500 mcg	10	586
other	Astenia	General disorders	IFNB-1b 250 mcg	14	645
other	Astenia	General disorders	IFNB-1b 250 mcg*	0	180
other	Chills	General disorders	IFNB-1b 500 mcg	4	586
other	Chills	General disorders	IFNB-1b 250 mcg	7	645
other	Chills	General disorders	IFNB-1b 250 mcg*	4	180
other	Fatigue	General disorders	IFNB-1b 500 mcg	89	586
other	Fatigue	General disorders	IFNB-1b 250 mcg	89	645
other	Fatigue	General disorders	IFNB-1b 250 mcg*	23	180
other	Influenza like illness	General disorders	IFNB-1b 500 mcg	72	586

1 to 10 of 297Source ClinicalTrials.gov

See all 297 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IFNB-1b 500 mcg
Total, all-cause mortality	IFNB-1b 250 mcg
Total, all-cause mortality	IFNB-1b 250 mcg*
Total, other adverse events	IFNB-1b 500 mcg	455	586
Total, other adverse events	IFNB-1b 250 mcg	467	645
Total, other adverse events	IFNB-1b 250 mcg*	136	180
Total, serious adverse events	IFNB-1b 500 mcg	11	586
Total, serious adverse events	IFNB-1b 250 mcg	16	645
Total, serious adverse events	IFNB-1b 250 mcg*	6	180

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21952094	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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