Trial Outcomes & Findings for Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Patients With Plaque Psoriasis (NCT NCT02274792)

NCT ID: NCT02274792

Last Updated: 2016-12-29

Results Overview

Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 132 participants
• Primary outcome timeframe: Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24.
• Results posted on: 2016-12-29

Participant Flow

This study was conducted at 39 centers in North America (United States and Canada). The first participant enrolled on 29 January 2015 and the last participant was enrolled on 08 May 2015.

Participant milestones

Measure	Etanercept Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
Overall Study STARTED	132
Overall Study Received Treatment	131
Overall Study COMPLETED	107
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Measure	Etanercept Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
Overall Study Withdrawal by Subject	13
Overall Study Lost to Follow-up	8
Overall Study Protocol Specified Criteria	2
Overall Study Sponsor Decision	2

Baseline Characteristics

Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Patients With Plaque Psoriasis

Baseline characteristics by cohort

Measure	Etanercept n=131 Participants Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
Age, Continuous	46.3 years STANDARD_DEVIATION 13.2 • n=5 Participants
Age, Customized < 65 years	114 participants n=5 Participants
Age, Customized ≥ 65 years	17 participants n=5 Participants
Gender Female	42 Participants n=5 Participants
Gender Male	89 Participants n=5 Participants
Race/Ethnicity, Customized Asian	8 participants n=5 Participants
Race/Ethnicity, Customized Black	7 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 participants n=5 Participants
Race/Ethnicity, Customized White	112 participants n=5 Participants
Race/Ethnicity, Customized Other	3 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	20 participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic/Latino	111 participants n=5 Participants
Duration of Psoriasis	18.1 years STANDARD_DEVIATION 12.6 • n=5 Participants

PRIMARY outcome

Timeframe: Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24.

Population: Primary Antibody Analysis Set included all enrolled participants who received ≥ 1 dose of investigational product and had both a baseline and ≥ 1 post-baseline serum obtained for anti-etanercept antibody assessment, excluding participants with a negative antibody response at week 12 and missing antibody assessment at week 24.

Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Measure	Etanercept n=106 Participants Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study	3.8 percentage of participants Interval 1.04 to 9.38

SECONDARY outcome

Timeframe: Week 24

Population: Participants with available antibody response data at week 24

Outcome measures

Measure	Etanercept n=105 Participants Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24	1.0 percentage of participants Interval 0.02 to 5.19

SECONDARY outcome

Timeframe: Week 12

Population: Participants with available antibody response data at week 12

Outcome measures

Measure	Etanercept n=120 Participants Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12	2.5 percentage of participants Interval 0.52 to 7.13

SECONDARY outcome

Timeframe: Week 24

Population: Participants with a positive anti-etanercept antibody binding response at week 24

Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.

Outcome measures

Measure	Etanercept n=1 Participants Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24	0.0 percentage of participants Interval 0.0 to 97.5

SECONDARY outcome

Timeframe: Week 12

Population: Participants with a positive anti-etanercept antibody binding response at week 12

Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.

Outcome measures

Measure	Etanercept n=3 Participants Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12	0.0 percentage of participants Interval 0.0 to 70.76

Adverse Events

Etanercept

Serious events: 5 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	Etanercept n=131 participants at risk Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
Cardiac disorders Myocardial infarction	0.76% 1/131 • From the first dose of investigational product through 30 days after last dose; 28 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abdominal wall infection	0.76% 1/131 • From the first dose of investigational product through 30 days after last dose; 28 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis	1.5% 2/131 • From the first dose of investigational product through 30 days after last dose; 28 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Asthma	0.76% 1/131 • From the first dose of investigational product through 30 days after last dose; 28 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Measure	Etanercept n=131 participants at risk Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
General disorders Injection site reaction	7.6% 10/131 • From the first dose of investigational product through 30 days after last dose; 28 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	5.3% 7/131 • From the first dose of investigational product through 30 days after last dose; 28 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Psoriasis	6.1% 8/131 • From the first dose of investigational product through 30 days after last dose; 28 weeks. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER