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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03357471
• Date of registration: 23/11/2017
• Prospective Registration: No
• 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
• 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 Psoriatic Arthritis

Moderate and Severe Active Rheumatoid Arthritis

Active Ankylosing Spondylitis

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)

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 Body Temperature [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)]

Mean Change From Baseline in Systolic Blood Pressure [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)]

Incidence of Adverse Events (AEs) During the Study [Time Frame: During the study (from Week 0 up to Week 5 +/-3 Days)]

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)]

Mean Change From Baseline in Pulse Rate [Time Frame: From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)]

Incidence of Adverse Device Events (ADEs) During the Study [Time Frame: During the study (from Week 0 up to Week 5 +/-3 Days)]

Secondary ID(s)

RA0098

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/10/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03357471