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

Phase 3 Completed 70 enrolled UCB Biopharma S.P.R.L.

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2017-11-03
Primary completion: 2018-07-02
Completion: 2018-07-02

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Certolizumab Pegol	Protein / enzyme biologic	200 mg	Subcutaneous
Subject	Certolizumab Pegol	Protein / enzyme biologic	400 mg	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications