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

A Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous 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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03357471

Enrollment

Registered

2017-11-30

Start date

2017-11-03

Completion date

2018-07-02

Last updated

2019-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate and Severe Active Rheumatoid Arthritis, Active Psoriatic Arthritis, Active Ankylosing Spondylitis, Moderately to Severely Active Crohn's Disease

Keywords

Certolizumab Pegol, E-Device

Brief summary

The purpose of the study is to evaluate the ability of subjects who are already prescribed Certolizumab Pergol therapy and have been self injecting with prefilled syringes for at least the previous three months, to safely and effectively self-inject Certolizumab Pegol (CZP) using the e-Device and to evaluate the post-use structural integrity of used devices and cassettes via visual examination.

Interventions

DRUGe-Device

* Active Substance: Certolizumab Pegol * Pharmaceutical form: Solution for injection * Route of administration: subcutaneous injection by e-Device

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject is male or female and must be at least 18 years old at Visit 1 * Subject must have been diagnosed at least 6 months prior to Visit 1 with documented moderate to severe active Rheumatoid Arthritis (RA), active Psoriatic Arthritis (PsA), active Ankylosing Spondylitis (AS) (in US), or moderately to severely active Crohn's Disease (CD) (in US) * A minimum of 10 subjects will have impaired hand function. Impaired hand function will be measured using the Cochin scale (Duruöz et al, 1996; Poiraudeau et al, 2000) and impaired hand function will be defined as patients who have a Cochin score \>= 13.5 at Baseline * Subjects must have been prescribed Certolizumab Pegol (CZP) and must have been self-injecting CZP using the pre-filled syringe for at least 3 months prior to Visit 1. Subjects with RA, PsA, or AS must have been on a stable Q2W (every 2 weeks) or Q4W (every 4 weeks) CZP dosing regimen for at least 3 months prior to Screening. Subjects with CD must have been on a stable Q4W CZP dosing regimen for at least 3 months prior to Visit 1. * Subjects must have been screened according to the applicable national tuberculosis (TB) screening guidelines (to be documented) or provide a documented TB screening activity (TB questionnaire, Interferon-Gamma-Release Assay (IGRA) test, or chest x-ray) within the past 12 months prior to Visit 1. * Female subjects of childbearing potential should have a negative pregnancy test at Visit 1 and should be using a medically accepted method of contraception during the entire duration of the study. Female subjects who are postmenopausal for at least 2 years or have undergone a complete hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy, or have a congenital sterility are considered not of childbearing potential

Exclusion criteria

* Subject has participated in another study of an investigational medicinal product (IMP) or an investigational device within the previous 3 months or is currently participating in another study of an IMP or an investigational device * Subject has a history of chronic alcohol or drug abuse within the previous 6 months * Subject has a history of significant cardiovascular, respiratory, gastrointestinal, hepatic, endocrine, renal, dermatological, neurological, psychiatric, hematological, or bleeding disorders * Subjects with known Tuberculosis (TB) infection and at high risk of acquiring TB infection. Subjects with latent TB (LTB) who have not completed the prophylactic treatment regimen for LTB 3 months prior to enrollment * Subject has an active chronic/latent infection including but not limited to TB (untreated latent or active), hepatitis virus (HV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) * Subject has a current malignancy or a history of malignancy. Subjects with less than 3 completely excised basal cell carcinomas or with cervical carcinoma in situ successfully treated surgically more than 5 years prior to Screening may be included * Subject has had major surgery (including joint surgery) within 8 weeks prior to Visit 1, or has a scheduled surgery during the study

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 2	Visit 2 (Week 2 for Q2W; Week 4 for Q4W)	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.

Secondary

Measure	Time frame	Description
Percentage of Used Certolizumab Pegol (CZP)-Cassettes Identified as Having Structural Integrity Issues Based on Visual Examination	During the study (from Week 0 up to Week 4)	CZP-cassettes identified as having structural integrity issues meant CZP-cassettes with clear evidence of damage/compromised structural integrity, not superficial cosmetic imperfections.
Mean Change From Baseline in Systolic Blood Pressure	From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)	Blood pressure was measured in millimetre of mercury (mmHg).
Mean Change From Baseline in Diastolic Blood Pressure	From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)	Blood pressure was measured in millimetre of mercury (mmHg).
Mean Change From Baseline in Pulse Rate	From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)	Pulse Rate was measured in beats per minute (beats/min).
Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 1	Visit 1 (Week 0)	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.
Mean Change From Baseline in Body Temperature	From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)	Body Temperature was measured in Grad Celsius (°C).
Incidence of Adverse Events (AEs) During the Study	During the study (from Week 0 up to Week 5 +/-3 Days)	An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product (IMP), whether or not related to the medicinal (investigational) product.
Incidence of Adverse Device Events (ADEs) During the Study	During the study (from Week 0 up to Week 5 +/-3 Days)	An Adverse Device Event (ADE) was an AE related to the use of an investigational device. An ADE must have met 1 or more of the following criteria: * Adverse event that resulted from insufficiencies or inadequacies in the Instructions for Use (IFU), the deployment, the implantation, the installation, the operation, or any malfunction of the investigational medical device * Adverse event that was a result of an error or intentional misuse.
Mean Change From Baseline in Respiratory Rate	From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)	Respiratory Rate was measured in breaths per minute (breaths/min).

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

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).

Participants by arm

Arm	Count
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.	35
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.	32
Total Title	67
Total	134

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	0
Overall Study	Lost to Follow-up	1	0

Baseline characteristics

Characteristic	Total Title	Certolizumab Pegol Q4W Injection by e-Device	Certolizumab Pegol Q2W Injection by e-Device
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	14 Participants	8 Participants	6 Participants
Age, Categorical Between 18 and 65 years	53 Participants	24 Participants	29 Participants
Age, Continuous	52.4 years STANDARD_DEVIATION 13.2	52.6 years STANDARD_DEVIATION 13.6	52.3 years STANDARD_DEVIATION 13.1
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Black	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized Missing	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized White	63 Participants	30 Participants	33 Participants
Sex: Female, Male Female	46 Participants	25 Participants	21 Participants
Sex: Female, Male Male	21 Participants	7 Participants	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 35	0 / 32
other Total, other adverse events	0 / 35	0 / 32
serious Total, serious adverse events	0 / 35	0 / 32

Outcome results

Primary

Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 2

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.

Time frame: 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.

Arm	Measure	Value (NUMBER)
Certolizumab Pegol Q2W Injection by e-Device (SS)	Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 2	100.00 percentage of subjects
Certolizumab Pegol Q4W Injection by e-Device (SS)	Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 2	96.88 percentage of subjects

Secondary

Incidence of Adverse Device Events (ADEs) During the Study

An Adverse Device Event (ADE) was an AE related to the use of an investigational device. An ADE must have met 1 or more of the following criteria: * Adverse event that resulted from insufficiencies or inadequacies in the Instructions for Use (IFU), the deployment, the implantation, the installation, the operation, or any malfunction of the investigational medical device * Adverse event that was a result of an error or intentional misuse.

Time frame: During the study (from Week 0 up to Week 5 +/-3 Days)

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).

Arm	Measure	Value (NUMBER)
Certolizumab Pegol Q2W Injection by e-Device (SS)	Incidence of Adverse Device Events (ADEs) During the Study	0 percentage of participants
Certolizumab Pegol Q4W Injection by e-Device (SS)	Incidence of Adverse Device Events (ADEs) During the Study	3.1 percentage of participants

Secondary

Incidence of Adverse Events (AEs) During the Study

An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product (IMP), whether or not related to the medicinal (investigational) product.

Time frame: During the study (from Week 0 up to Week 5 +/-3 Days)

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).

Arm	Measure	Value (NUMBER)
Certolizumab Pegol Q2W Injection by e-Device (SS)	Incidence of Adverse Events (AEs) During the Study	14.3 percentage of participants
Certolizumab Pegol Q4W Injection by e-Device (SS)	Incidence of Adverse Events (AEs) During the Study	12.5 percentage of participants

Secondary