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



Status:Completed
Conditions:Arthritis, Neurology, Neurology, Crohns Disease
Therapuetic Areas:Gastroenterology, Neurology, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:November 3, 2017
End Date:July 3, 2018

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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

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.


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
We found this trial at
22
sites
Nassau Bay, Texas 77058
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Austin, Texas 78731
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Austin, Texas 78745
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Austin, TX
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Austin, Texas 78758
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Austin, TX
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Clermont, Florida 34711
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Clermont, FL
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Clive, Iowa 50265
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Clive, IA
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Coral Springs, Florida 33071
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Coral Springs, FL
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Corpus Christi, Texas 78404
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Corpus Christi, TX
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Covina, California 91722
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Covina, CA
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Dover, New Jersey 07801
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Dover, NJ
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Gainesville, Georgia 30501
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Gainesville, GA
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Great Neck, New York 11021
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Great Neck, NY
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Hixson, Tennessee 37343
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Hixson, TN
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Mesa, Arizona 85202
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Mesa, AZ
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Mesa, Arizona 85306
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Mesa, AZ
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Myrtle Beach, South Carolina 29572
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Myrtle Beach, SC
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Phoenix, Arizona 85037
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Phoenix, AZ
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Richland, Washington 99352
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Richland, WA
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Saint Louis, Missouri 63128
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Saint Louis, MO
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Saint Louis, Missouri 63110
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Saint Louis, MO
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San Antonio, Texas 78229
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San Antonio, TX
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Tucson, Arizona 85704
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Tucson, AZ
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