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
Condition: Moderate and Severe Active Rheumatoid Arthritis; Active Psoriatic Arthritis; Active Ankylosing Spondylitis; Moderately to Severely Active Crohn's Disease
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing; Crohn Disease
Intervention: e-Device
Intervention description: Active Substance: Certolizumab Pegol
Pharmaceutical form: Solution for injection
Route of administration: subcutaneous injection by e-Device
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol; E-Device

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.
    

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