Status:
COMPLETED
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
Lead Sponsor:
UCB Biopharma S.P.R.L.
Conditions:
Moderate and Severe Active Rheumatoid Arthritis
Active Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03357471
Start Date
November 3 2017
End Date
July 2 2018
Last Update
October 25 2019
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
Ra0098 116
Mesa, Arizona, United States, 85202
2
Ra0098 107
Mesa, Arizona, United States, 85306
3
Ra0098 135
Phoenix, Arizona, United States, 85037
4
Ra0098 119
Tucson, Arizona, United States, 85704