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NCT02065622 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

A Phase 3 study of Ulcerative Colitis (UC), sponsored by AbbVie.

Completed
Registry status
Phase 3
Development phase
952
Enrollment target
20
Study locations

NCT02065622 is a Phase 3 study of Ulcerative Colitis (UC) that has completed, run by AbbVie. The registered enrollment target is 952 participants, above the 709-participant average among 17 other Ulcerative Colitis (UC) trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT02065622, a Phase 3 study of Ulcerative Colitis (UC), has completed, sponsored by AbbVie.

COMPLETED
Registry status
Phase 3
Development phase
952 participants
Enrollment target
20
Study locations

Study Summary

To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.

Conditions Studied

Ulcerative Colitis (UC)

Interventions

  • OTHER Placebo
  • DRUG Adalimumab

Study Locations (20)

Florida

  • Gastro Florida /ID# 170619 - Clearwater
  • Research Associates of South Florida,LLC /ID# 170309 - Miami
  • Gastroenterology Group Naples /ID# 127806 - Naples
  • Shafran Gastroenterology Ctr /ID# 122320 - Winter Park

Illinois

  • Northwestern University Feinberg School of Medicine /ID# 122183 - Chicago
  • University of Chicago /ID# 122302 - Chicago
  • Carle Foundation Hospital /ID# 135955 - Urbana

Georgia

  • Atlanta Gastro Assoc /ID# 122336 - Atlanta
  • Gastro Assoc of Central GA /ID# 122318 - Macon

Maryland

  • University of Maryland Med Ctr /ID# 169734 - Baltimore
  • MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238 - Chevy Chase

Alabama

  • Digestive Health Specialists of the Southeast /ID# 127844 - Dothan

California

  • Ucsd /Id# 122313 - La Jolla

Colorado

  • Rocky Mountain Clinical Resear /ID# 122180 - Wheat Ridge

Connecticut

  • Medical Research Ctr CT /ID# 122179 - Hamden

Trial Details

FieldValue
Enrollment Target 952 participants
Start Date 2014-03-27
Est. Completion 2019-11-11
Phase Phase 3

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02065622

The ClinicalTrials.gov registry entry for NCT02065622 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 952 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 709-participant average among 17 other Ulcerative Colitis (UC) trials with a reported enrollment target (34% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ulcerative Colitis (UC) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02065622 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Illinois, Georgia.

Frequently Asked Questions

What is clinical trial NCT02065622 about?

NCT02065622 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis". To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.

What is the current status of trial NCT02065622?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 952 participants. The study started on 2014-03-27. Estimated completion is 2019-11-11.

What conditions does trial NCT02065622 study?

This clinical trial studies the following conditions: Ulcerative Colitis (UC).

What interventions are being tested in trial NCT02065622?

The interventions under investigation include: Placebo (OTHER), Adalimumab (DRUG).

Who is sponsoring clinical trial NCT02065622?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02065622 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.