Trial Outcomes & Findings for Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease (NCT NCT03357471)

Results Overview

Safe and effective self-injection was evaluated by the healthcare provider and is defined as: * Dose Delivery: Subject self-injected the complete dose of Certolizumab Pegol (CZP) as confirmed by a visual inspection of the CZP-cassette(s) which shows the pre-filled syringe container to be empty AND * No Adverse Events related to use of the e-Device (Adverse Device Effects) that would preclude continued use of the e-Device for self-injection. For subjects on the Q4W (every 4 weeks) dosing regimen who would self-inject twice (2×200 mg CZP) at each visit, each injection was evaluated for safety and effectiveness using the above criteria. The primary endpoint of safe and effective self-injection for subjects on the Q4W dosing regimen was met only if both self-injections were determined to be safe and effective.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

70 participants

Primary outcome timeframe

Visit 2 (Week 2 for Q2W; Week 4 for Q4W)

Results posted on

2019-10-25

Participant Flow

The study started to enroll patients in November 2017 and concluded in July 2018.

Participant Flow refers to the Safety Set (SS), which consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device).

Participant milestones

Participant milestones
Measure	Certolizumab Pegol Q2W Injection by e-Device Subjects self-injected Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks.	Certolizumab Pegol Q4W Injection by e-Device Subjects self-injected Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks.
Overall Study STARTED	35	32
Overall Study COMPLETED	33	32
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Certolizumab Pegol Q2W Injection by e-Device Subjects self-injected Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks.	Certolizumab Pegol Q4W Injection by e-Device Subjects self-injected Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Certolizumab Pegol Q2W Injection by e-Device n=35 Participants Subjects self-injected Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks.	Certolizumab Pegol Q4W Injection by e-Device n=32 Participants Subjects self-injected Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks.	Total Title n=67 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	24 Participants n=7 Participants	53 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Age, Continuous	52.3 years STANDARD_DEVIATION 13.1 • n=5 Participants	52.6 years STANDARD_DEVIATION 13.6 • n=7 Participants	52.4 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 2 (Week 2 for Q2W; Week 4 for Q4W)

Population: The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). Percentages were based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.

Safe and effective self-injection was evaluated by the healthcare provider and is defined as: * Dose Delivery: Subject self-injected the complete dose of Certolizumab Pegol (CZP) as confirmed by a visual inspection of the CZP-cassette(s) which shows the pre-filled syringe container to be empty AND * No Adverse Events related to use of the e-Device (Adverse Device Effects) that would preclude continued use of the e-Device for self-injection. For subjects on the Q4W (every 4 weeks) dosing regimen who would self-inject twice (2×200 mg CZP) at each visit, each injection was evaluated for safety and effectiveness using the above criteria. The primary endpoint of safe and effective self-injection for subjects on the Q4W dosing regimen was met only if both self-injections were determined to be safe and effective.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol Q2W Injection by e-Device (SS) n=33 Participants Subjects self-injected Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks. Subjects formed the Safety Set (SS).	Certolizumab Pegol Q4W Injection by e-Device (SS) n=32 Participants Subjects self-injected Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks. Subjects formed the Safety Set (SS).
Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 2	100.00 percentage of subjects Interval 91.3 to 100.0	96.88 percentage of subjects Interval 86.0 to 99.8

SECONDARY outcome

Timeframe: Visit 1 (Week 0)

Population: The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). Percentages were based on the number of SS subjects that participated in Visit 1 and received at least 1 dose of CZP.

Safe and effective self-injection was evaluated by the healthcare provider and is defined as: * Dose Delivery: Subject self-injected the complete dose of Certolizumab Pegol (CZP) as confirmed by a visual inspection of the CZP-cassette(s) which shows the pre-filled syringe container to be empty AND * No Adverse Events related to use of the e-Device (Adverse Device Effects) that would preclude continued use of the e-Device for self-injection. For subjects on the Q4W (every 4 weeks) dosing regimen who would self-inject twice (2×200 mg CZP) at each visit, each injection was evaluated for safety and effectiveness using the above criteria. The primary endpoint of safe and effective self-injection for subjects on the Q4W dosing regimen was met only if both self-injections were determined to be safe and effective.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol Q2W Injection by e-Device (SS) n=35 Participants Subjects self-injected Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks. Subjects formed the Safety Set (SS).	Certolizumab Pegol Q4W Injection by e-Device (SS) n=32 Participants Subjects self-injected Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks. Subjects formed the Safety Set (SS).
Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 1	100.00 percentage of subjects Interval 91.8 to 100.0	100.00 percentage of subjects Interval 91.1 to 100.0

SECONDARY outcome

Timeframe: During the study (from Week 0 up to Week 4)

Population: The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). Percentages were based on the number of cassettes evaluated.

CZP-cassettes identified as having structural integrity issues meant CZP-cassettes with clear evidence of damage/compromised structural integrity, not superficial cosmetic imperfections.