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

Phase 3

Completed

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

Interventions: Drug: e-Device

Registration Number: NCT03357471

Lead Sponsor: UCB Biopharma S.P.R.L.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 70

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Certolizumab Pegol Q2W injection by e-Device	e-Device	Subjects will self-inject Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks.
Certolizumab Pegol Q4W injection by e-Device	e-Device	Subjects will self-inject Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
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).
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).

Trial Locations

Locations (22): Ra0098 116
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Mesa, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
Ra0098 119
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Tucson, Arizona, United States
Ra0098 101
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Covina, California, United States
Ra0098 131
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Clermont, Florida, United States
Ra0098 132
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Coral Springs, Florida, United States
Ra0098 127
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Gainesville, Georgia, United States
Ra0098 122
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Clive, Iowa, United States
Ra0098 105
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Saint Louis, Missouri, United States
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Ra0098 116
🇺🇸Mesa, Arizona, United States