Trial Outcomes & Findings for Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients (NCT NCT00784836)

Results Overview

The presence of antibodies to IFN-beta in human serum, determined using a tiered approach involving a screening Enzyme-Linked ImmunoSorbent Assay (ELISA) to detect binding antibodies (BAbs). Positive samples characterized and titrated in a cell-based neutralizing antibody (NAb) assay.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

3 participants

Primary outcome timeframe

assessed every 3 months up to 18 months

Results posted on

2014-05-07

Participant Flow

The study expected an enrollment of 150 participants, but terminated after 3 were enrolled.

Participant milestones

Participant milestones
Measure	Avonex Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Avonex Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
Overall Study Early Study Termination	3

Baseline Characteristics

Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Avonex n=3 Participants Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
Age, Customized <=18 years	0 participants n=5 Participants
Age, Customized Between 18 and 60 years	3 participants n=5 Participants
Age, Customized > 60 years	0 participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: assessed every 3 months up to 18 months

Population: The study was terminated early before any of the 3 enrolled subjects completed the study; therefore, no statistical analysis was performed.

The presence of antibodies to IFN-beta in human serum, determined using a tiered approach involving a screening Enzyme-Linked ImmunoSorbent Assay (ELISA) to detect binding antibodies (BAbs). Positive samples characterized and titrated in a cell-based neutralizing antibody (NAb) assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Planned for up to 18 months plus 30 days; actual study duration was 111 days.

AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.

Outcome measures

Outcome measures
Measure	Avonex n=3 Participants Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	3 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 participants

Adverse Events

Avonex

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Avonex n=3 participants at risk Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
General disorders Injection site reaction	33.3% 1/3 • Planned for up to 18 months plus 30 days; actual study duration was 111 days.
General disorders Influenza like illness	66.7% 2/3 • Planned for up to 18 months plus 30 days; actual study duration was 111 days.
Investigations Hepatic enzyme increased	33.3% 1/3 • Planned for up to 18 months plus 30 days; actual study duration was 111 days.

Additional Information

Biogen Idec Medical Director

Biogen Idec Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Publication restrictions are in place

Restriction type: OTHER