Clinical trial NCT03357471: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-11-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 2
timeFrame: Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
Secondary outcomes:
measure: Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 1
timeFrame: Visit 1 (Week 0)
measure: Percentage of Used Certolizumab Pegol (CZP)-Cassettes Identified as Having Structural Integrity Issues Based on Visual Examination
timeFrame: During the study (from Week 0 up to Week 4)
measure: Mean Change From Baseline in Systolic Blood Pressure
timeFrame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
measure: Mean Change From Baseline in Diastolic Blood Pressure
timeFrame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
measure: Mean Change From Baseline in Pulse Rate
timeFrame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
measure: Mean Change From Baseline in Respiratory Rate
timeFrame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
measure: Mean Change From Baseline in Body Temperature
timeFrame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
measure: Incidence of Adverse Events (AEs) During the Study
timeFrame: During the study (from Week 0 up to Week 5 +/-3 Days)
measure: Incidence of Adverse Device Events (ADEs) During the Study
timeFrame: During the study (from Week 0 up to Week 5 +/-3 Days)
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Ra0098 116
state: Arizona
city: Mesa
country: United States
facility: Ra0098 107
state: Arizona
city: Phoenix
country: United States
facility: Ra0098 135
state: Arizona
city: Tucson
country: United States
facility: Ra0098 119
state: Arizona
city: Covina
country: United States
facility: Ra0098 101
state: California
city: Clermont
country: United States
facility: Ra0098 131
state: Florida
city: Coral Springs
country: United States
facility: Ra0098 132
state: Florida
city: Gainesville
country: United States
facility: Ra0098 127
state: Georgia
city: Clive
country: United States
facility: Ra0098 122
state: Iowa
city: Saint Louis
country: United States
facility: Ra0098 105
state: Missouri
city: Saint Louis
country: United States
facility: Ra0098 104
state: Missouri
city: Dover
country: United States
facility: Ra0098 103
state: New Jersey
city: Great Neck
country: United States
facility: Ra0098 117
state: New York
city: Myrtle Beach
country: United States
facility: Ra0098 113
state: South Carolina
city: Hixson
country: United States
facility: Ra0098 126
state: Tennessee
city: Austin
country: United States
facility: Ra0098 111
state: Texas
city: Austin
country: United States
facility: Ra0098 123
state: Texas
city: Austin
country: United States
facility: Ra0098 102
state: Texas
city: Corpus Christi
country: United States
facility: Ra0098 128
state: Texas
city: Nassau Bay
country: United States
facility: Ra0098 106
state: Texas
city: San Antonio
country: United States
facility: Ra0098 114
state: Texas
city: Richland
country: United States
facility: Ra0098 133
state: Washington
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Pompilus F, Ciesluk A, Strzok S, Ciaravino V, Harris K, Szegvari B, Mountian I, Cleanthous S, Meunier J. Development and psychometric evaluation of the assessment of self-injection questionnaire: an adaptation of the self-injection assessment questionnaire. Health Qual Life Outcomes. 2020 Nov 4;18(1):355. doi: 10.1186/s12955-020-01606-7.