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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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ClinicalTrials.gov Identifier: NCT03357471
Recruitment Status : Completed
First Posted : November 30, 2017
Results First Posted : October 25, 2019
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Moderate and Severe Active Rheumatoid Arthritis
Active Psoriatic Arthritis
Active Ankylosing Spondylitis
Moderately to Severely Active Crohn's Disease
Intervention Drug: e-Device
Enrollment 70
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).
Arm/Group Title Certolizumab Pegol Q2W Injection by e-Device Certolizumab Pegol Q4W Injection by e-Device
Hide Arm/Group Description Subjects self-injected Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks. Subjects self-injected Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks.
Period Title: Overall Study
Started 35 32
Completed 33 32
Not Completed 2 0
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             1             0
Arm/Group Title Certolizumab Pegol Q2W Injection by e-Device Certolizumab Pegol Q4W Injection by e-Device Total Title
Hide Arm/Group Description Subjects self-injected Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks. Subjects self-injected Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks. [Not Specified]
Overall Number of Baseline Participants 35 32 67
Hide Baseline Analysis Population Description
Baseline Characteristics refers to the Safety Set which consisted of all subjects who received at least 1 dose of CZP during the study (e-Device).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 32 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
  82.9%
24
  75.0%
53
  79.1%
>=65 years
6
  17.1%
8
  25.0%
14
  20.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 32 participants 67 participants
52.3  (13.1) 52.6  (13.6) 52.4  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 32 participants 67 participants
Female
21
  60.0%
25
  78.1%
46
  68.7%
Male
14
  40.0%
7
  21.9%
21
  31.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 32 participants 67 participants
American Indian or Alaska Native
1
   2.9%
0
   0.0%
1
   1.5%
Black
1
   2.9%
0
   0.0%
1
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   3.1%
1
   1.5%
White
33
  94.3%
30
  93.8%
63
  94.0%
Missing
0
   0.0%
1
   3.1%
1
   1.5%
1.Primary Outcome
Title Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 2
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 33 32
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of subjects
100.00
(91.3 to 100.0)
96.88
(86.0 to 99.8)
2.Secondary Outcome
Title Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 1
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 35 32
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of subjects
100.00
(91.8 to 100.0)
100.00
(91.1 to 100.0)
3.Secondary Outcome
Title Percentage of Used Certolizumab Pegol (CZP)-Cassettes Identified as Having Structural Integrity Issues Based on Visual Examination
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 35 32
Overall Number of Units Analyzed
Type of Units Analyzed: CZP - cassettes
68 128
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of cassettes
0
(0.0 to 4.3)
0
(0.0 to 2.3)
4.Secondary Outcome
Title Mean Change From Baseline in Systolic Blood Pressure
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.
Arm/Group Title Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 33 32
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.12  (9.04) -2.31  (10.98)
5.Secondary Outcome
Title Mean Change From Baseline in Diastolic Blood Pressure
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.
Arm/Group Title Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 33 32
Mean (Standard Deviation)
Unit of Measure: mmHg
-1.21  (7.03) -2.25  (10.24)
6.Secondary Outcome
Title Mean Change From Baseline in Pulse Rate
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.
Arm/Group Title Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 33 32
Mean (Standard Deviation)
Unit of Measure: beats/min
-0.42  (6.45) -0.97  (9.32)
7.Secondary Outcome
Title Mean Change From Baseline in Respiratory Rate
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.
Arm/Group Title Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 33 32
Mean (Standard Deviation)
Unit of Measure: breaths/min
-0.48  (1.73) -0.19  (2.18)
8.Secondary Outcome
Title Mean Change From Baseline in Body Temperature
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.
Arm/Group Title Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 33 32
Mean (Standard Deviation)
Unit of Measure: Temperature (C)
0.05  (0.41) -0.06  (0.34)
9.Secondary Outcome
Title Incidence of Adverse Events (AEs) During the Study
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 35 32
Measure Type: Number
Unit of Measure: percentage of participants
14.3 12.5
10.Secondary Outcome
Title Incidence of Adverse Device Events (ADEs) During the Study
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 35 32
Measure Type: Number
Unit of Measure: percentage of participants
0 3.1
Time Frame From the start of Treatment Period at Week 0 and up to Safety Follow-Up (1 week after the subject's final site visit using the e-Device), an average of 5 Weeks +/-3 Days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Hide Arm/Group Description 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). 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).
All-Cause Mortality
Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/32 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Certolizumab Pegol Q2W Injection by e-Device (SS) Certolizumab Pegol Q4W Injection by e-Device (SS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/32 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
ClinicalTrials.gov Identifier: NCT03357471     History of Changes
Other Study ID Numbers: RA0098
First Submitted: November 23, 2017
First Posted: November 30, 2017
Results First Submitted: July 2, 2019
Results First Posted: October 25, 2019
Last Update Posted: October 25, 2019