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NCT03357471 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study of Moderately to Severely Active Crohn's Disease and Active Psoriatic Arthritis, sponsored by UCB Biopharma S.P.R.L..
- Completed
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT03357471: Completed Phase 3 study of Moderately to Severely Active Crohn's Disease and Active Psoriatic Arthritis, sponsored by UCB Biopharma S.P.R.L..
NCT03357471 is a Phase 3 study of Moderately to Severely Active Crohn's Disease and Active Psoriatic Arthritis that has completed, run by UCB Biopharma S.P.R.L.. The registered enrollment target is 70 participants, below the 443-participant average among 3 other Moderately to Severely Active Crohn's Disease trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03357471, a Phase 3 study of Moderately to Severely Active Crohn's Disease and Active Psoriatic Arthritis, has completed, sponsored by UCB Biopharma S.P.R.L..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Safe and effective self-injection was evaluated by the healthcare provider and is defined as: * Dose Delivery: Subject self-injected the complete dose of Certolizumab Pegol (CZP) as confirmed by a visual inspection of the CZP-cassette(s) which shows the pre-filled syringe container to be empty AND * No Adverse Events related to use of the e-Device (Adverse Device Effects) that would preclude continued use of the e-Device for self-injection. For subjects on the Q4W (every 4 weeks) dosing regime
Conditions Studied
Interventions
- DRUG e-Device
Study Locations (20)
Texas
- Ra0098 111 - Austin
- Ra0098 123 - Austin
- Ra0098 102 - Austin
- Ra0098 128 - Corpus Christi
- Ra0098 106 - Nassau Bay
Arizona
- Ra0098 116 - Mesa
- Ra0098 107 - Mesa
- Ra0098 135 - Phoenix
- Ra0098 119 - Tucson
Florida
- Ra0098 131 - Clermont
- Ra0098 132 - Coral Springs
Missouri
- Ra0098 105 - St Louis
- Ra0098 104 - St Louis
California
- Ra0098 101 - Covina
Georgia
- Ra0098 127 - Gainesville
Iowa
- Ra0098 122 - Clive
New Jersey
- Ra0098 103 - Dover
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2017-11-03 |
| Est. Completion | 2018-07-02 |
| Phase | Phase 3 |
What the finished NCT03357471 record still lists
NCT03357471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 443-participant average among 3 other Moderately to Severely Active Crohn's Disease trials with a reported enrollment target (84% lower).
The record links to 4 conditions, with Moderately to Severely Active Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which e-Device is the first listed.
NCT03357471 names 20 study sites across 11 states, led by Texas, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT03357471 about?
NCT03357471 is a clinical study titled "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". 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...
What is the current status of trial NCT03357471?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2017-11-03. Estimated completion is 2018-07-02.
What conditions does trial NCT03357471 study?
This clinical trial studies the following conditions: Moderately to Severely Active Crohn's Disease, Active Psoriatic Arthritis, Moderate and Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis.
What interventions are being tested in trial NCT03357471?
The interventions under investigation include: e-Device (DRUG).
Who is sponsoring clinical trial NCT03357471?
This trial is sponsored by UCB Biopharma S.P.R.L., which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03357471 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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