NCT03357471

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: UCB Biopharma S.P.R.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	e-Device	* Active Substance: Certolizumab Pegol * Pharmaceutical form: Solution for injection * Route of administration: subcutaneous injection by e-Device

Timeline

• Start date: 2017-11-03
• Primary completion: 2018-07-02
• Completion: 2018-07-02
• First posted: 2017-11-30
• Last updated: 2019-10-25
• Results posted: 2019-10-25

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study