Back to resultsStudy 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
Primary Purpose
Moderate and Severe Active Rheumatoid Arthritis, Active Psoriatic Arthritis, Active Ankylosing Spondylitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
e-Device
Sponsored by
About this trial
This is an interventional treatment trial for Moderate and Severe Active Rheumatoid Arthritis focused on measuring Certolizumab Pegol, E-Device
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
Sites / Locations
- Ra0098 116
- Ra0098 107
- Ra0098 135
- Ra0098 119
- Ra0098 101
- Ra0098 131
- Ra0098 132
- Ra0098 127
- Ra0098 122
- Ra0098 105
- Ra0098 104
- Ra0098 103
- Ra0098 117
- Ra0098 113
- Ra0098 126
- Ra0098 111
- Ra0098 123
- Ra0098 102
- Ra0098 128
- Ra0098 106
- Ra0098 114
- Ra0098 133
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Certolizumab Pegol Q2W injection by e-Device
Certolizumab Pegol Q4W injection by e-Device
Arm Description
Subjects will self-inject Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks.
Subjects will self-inject Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 1
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
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
Blood pressure was measured in millimetre of mercury (mmHg).
Mean Change From Baseline in Diastolic Blood Pressure
Blood pressure was measured in millimetre of mercury (mmHg).
Mean Change From Baseline in Pulse Rate
Pulse Rate was measured in beats per minute (beats/min).
Mean Change From Baseline in Respiratory Rate
Respiratory Rate was measured in breaths per minute (breaths/min).
Mean Change From Baseline in Body Temperature
Body Temperature was measured in Grad Celsius (°C).
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.
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.
Full Information
NCT ID
NCT03357471
First Posted
November 23, 2017
Last Updated
October 4, 2019
Sponsor
UCB Biopharma S.P.R.L.
1. Study Identification
Unique Protocol Identification Number
NCT03357471
Brief Title
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
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
July 2, 2018 (Actual)
Study Completion Date
July 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma S.P.R.L.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate and Severe Active Rheumatoid Arthritis, Active Psoriatic Arthritis, Active Ankylosing Spondylitis, Moderately to Severely Active Crohn's Disease
Keywords
Certolizumab Pegol, E-Device
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Certolizumab Pegol Q2W injection by e-Device
Arm Type
Experimental
Arm Description
Subjects will self-inject Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks.
Arm Title
Certolizumab Pegol Q4W injection by e-Device
Arm Type
Experimental
Arm Description
Subjects will self-inject Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
e-Device
Other Intervention Name(s)
Cimzia
Intervention Description
Active Substance: Certolizumab Pegol
Pharmaceutical form: Solution for injection
Route of administration: subcutaneous injection by e-Device
Primary Outcome Measure Information:
Title
Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 2
Description
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)
Secondary Outcome Measure Information:
Title
Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 1
Description
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 1 (Week 0)
Title
Percentage of Used Certolizumab Pegol (CZP)-Cassettes Identified as Having Structural Integrity Issues Based on Visual Examination
Description
CZP-cassettes identified as having structural integrity issues meant CZP-cassettes with clear evidence of damage/compromised structural integrity, not superficial cosmetic imperfections.
Time Frame
During the study (from Week 0 up to Week 4)
Title
Mean Change From Baseline in Systolic Blood Pressure
Description
Blood pressure was measured in millimetre of mercury (mmHg).
Time Frame
From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
Title
Mean Change From Baseline in Diastolic Blood Pressure
Description
Blood pressure was measured in millimetre of mercury (mmHg).
Time Frame
From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
Title
Mean Change From Baseline in Pulse Rate
Description
Pulse Rate was measured in beats per minute (beats/min).
Time Frame
From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
Title
Mean Change From Baseline in Respiratory Rate
Description
Respiratory Rate was measured in breaths per minute (breaths/min).
Time Frame
From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
Title
Mean Change From Baseline in Body Temperature
Description
Body Temperature was measured in Grad Celsius (°C).
Time Frame
From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)
Title
Incidence of Adverse Events (AEs) During the Study
Description
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)
Title
Incidence of Adverse Device Events (ADEs) During the Study
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ra0098 116
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Ra0098 107
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Ra0098 135
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
Ra0098 119
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Ra0098 101
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
Ra0098 131
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Facility Name
Ra0098 132
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Facility Name
Ra0098 127
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Ra0098 122
City
Clive
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Ra0098 105
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Ra0098 104
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Ra0098 103
City
Dover
State/Province
New Jersey
ZIP/Postal Code
07801
Country
United States
Facility Name
Ra0098 117
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Ra0098 113
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Ra0098 126
City
Hixson
State/Province
Tennessee
ZIP/Postal Code
37343
Country
United States
Facility Name
Ra0098 111
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Ra0098 123
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Ra0098 102
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Ra0098 128
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Ra0098 106
City
Nassau Bay
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Ra0098 114
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Ra0098 133
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33148261
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.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
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
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