At a glance
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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
In Brief
A Phase 3 clinical trial evaluating e-Device for Moderate and Severe Active Rheumatoid Arthritis and 3 related conditions. Completed, enrolled 70 participants across 22 sites.
Detailed 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.
Study Details
Timeline
Interventions
* Active Substance: Certolizumab Pegol * Pharmaceutical form: Solution for injection * Route of administration: subcutaneous injection by e-Device