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

NCT ID: NCT03357471

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-03
• Study Completion Date: 2018-07-02

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 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.

Conditions

Moderate and Severe Active Rheumatoid Arthritis; Active Psoriatic Arthritis; Active Ankylosing Spondylitis; Moderately to Severely Active Crohn's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Certolizumab Pegol Q2W injection by e-Device

Subjects will self-inject Certolizumab Pegol 200 mg (1 x 200 mg injection) using the e-Device every 2 weeks.

Group Type: EXPERIMENTAL

e-Device

Intervention Type: DRUG

• Active Substance: Certolizumab Pegol
• Pharmaceutical form: Solution for injection
• Route of administration: subcutaneous injection by e-Device

Certolizumab Pegol Q4W injection by e-Device

Subjects will self-inject Certolizumab Pegol 400 mg (2 x 200 mg injection) using the e-Device every 4 weeks.

Group Type: EXPERIMENTAL

e-Device

Intervention Type: DRUG

• Active Substance: Certolizumab Pegol
• Pharmaceutical form: Solution for injection
• Route of administration: subcutaneous injection by e-Device

Interventions

e-Device

• Active Substance: Certolizumab Pegol
• Pharmaceutical form: Solution for injection
• Route of administration: subcutaneous injection by e-Device

Intervention Type: DRUG

Other Intervention Names

Cimzia

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma S.P.R.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

Ra0098 116

Mesa, Arizona, United States

Ra0098 107

Mesa, Arizona, United States

Ra0098 135

Phoenix, Arizona, United States

Ra0098 119

Tucson, Arizona, United States

Ra0098 101

Covina, California, United States

Ra0098 131

Clermont, Florida, United States

Ra0098 132

Coral Springs, Florida, United States

Ra0098 127

Gainesville, Georgia, United States

Ra0098 122

Clive, Iowa, United States

Ra0098 105

St Louis, Missouri, United States

Ra0098 104

St Louis, Missouri, United States

Ra0098 103

Dover, New Jersey, United States

Ra0098 117

Great Neck, New York, United States

Ra0098 113

Myrtle Beach, South Carolina, United States

Ra0098 126

Hixson, Tennessee, United States

Ra0098 111

Austin, Texas, United States

Ra0098 123

Austin, Texas, United States

Ra0098 102

Austin, Texas, United States

Ra0098 128

Corpus Christi, Texas, United States

Ra0098 106

Nassau Bay, Texas, United States

Ra0098 114

San Antonio, Texas, United States

Ra0098 133

Richland, Washington, United States

Countries

United States

References

Pompilus F, Ciesluk A, Strzok S, Ciaravino V, Harris K, Szegvari B, Mountian I, Cleanthous S, Meunier J. Development and psychometric evaluation of the assessment of self-injection questionnaire: an adaptation of the self-injection assessment questionnaire. Health Qual Life Outcomes. 2020 Nov 4;18(1):355. doi: 10.1186/s12955-020-01606-7.

Reference Type: DERIVED

PMID: 33148261 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

RA0098

Identifier Type: -

Identifier Source: org_study_id