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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 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.

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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.

Conditions Studied

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

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

FieldValue
Enrollment Target 70 participants
Start Date 2017-11-03
Est. Completion 2018-07-02
Phase Phase 3

Sponsor

UCB Biopharma S.P.R.L.

23 total trials

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What the Registry Record Tells You About NCT03357471

The ClinicalTrials.gov registry entry for NCT03357471 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 443-participant average among 3 other Moderately to Severely Active Crohn's Disease trials with a reported enrollment target (84% lower). The listed sponsor is UCB Biopharma S.P.R.L., which has 23 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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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