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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03357471
Date of registration: 23/11/2017
Prospective Registration: Yes
Primary sponsor: UCB Biopharma S.P.R.L.
Public 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
Scientific 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
Date of first enrolment: November 3, 2017
Target sample size: 70
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03357471
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     UCB Cares
Address: 
Telephone:
Email:
Affiliation:  001 844 599 2273 (UCB)
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Active Ankylosing Spondylitis
Active Psoriatic Arthritis
Moderate and Severe Active Rheumatoid Arthritis
Moderately to Severely Active Crohn's Disease
Intervention(s)
Drug: e-Device
Primary Outcome(s)
Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 2 [Time Frame: Visit 2 (Week 2 for Q2W; Week 4 for Q4W)]
Secondary Outcome(s)
Incidence of Adverse Device Events (ADEs) During the Study [Time Frame: During the study (from Week 0 up to Week 5 +/-3 Days)]
Incidence of Adverse Events (AEs) During the Study [Time Frame: During the study (from Week 0 up to Week 5 +/-3 Days)]
Mean Change From Baseline in Body Temperature [Time Frame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)]
Mean Change From Baseline in Diastolic Blood Pressure [Time Frame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)]
Mean Change From Baseline in Pulse Rate [Time Frame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)]
Mean Change From Baseline in Respiratory Rate [Time Frame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)]
Mean Change From Baseline in Systolic Blood Pressure [Time Frame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)]
Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 1 [Time Frame: Visit 1 (Week 0)]
Percentage of Used Certolizumab Pegol (CZP)-Cassettes Identified as Having Structural Integrity Issues Based on Visual Examination [Time Frame: During the study (from Week 0 up to Week 4)]
Secondary ID(s)
RA0098
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 25/10/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT03357471
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