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NCT02065570 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

A Phase 3 study of Crohn's Disease, sponsored by AbbVie.

Completed
Registry status
Phase 3
Development phase
514
Enrollment target
20
Study locations

NCT02065570 is a Phase 3 study of Crohn's Disease that has completed, run by AbbVie. The registered enrollment target is 514 participants, below the 2,390-participant average among 105 other Crohn's Disease trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT02065570, a Phase 3 study of Crohn's Disease, has completed, sponsored by AbbVie.

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

Study Summary

This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Adalimumab

Study Locations (20)

Florida

  • Gastroenterology Group Naples /ID# 122493 - Naples
  • Internal Med Specialists /ID# 137737 - Orlando
  • Shafran Gastroenterology Ctr /ID# 119057 - Winter Park

Georgia

  • Winship Cancer Institute of Emory University /ID# 136851 - Atlanta
  • Atlanta Gastro Assoc /ID# 119065 - Atlanta
  • Gastroenterology Associates of Central Georgia, LLC /ID# 119056 - Macon

Illinois

  • Northwestern University Feinberg School of Medicine /ID# 119043 - Chicago
  • University of Chicago DCAM /ID# 119077 - Chicago
  • Carle Foundation Hospital Digestive Health Research Center /ID# 136008 - Urbana

Alabama

  • Birmingham Gastroenterology Associates O.C /ID# 137282 - Birmingham
  • Digestive Health Specialists of the Southeast /ID# 122483 - Dothan

California

  • Moore UC San Diego Cancer Center /ID# 119053 - La Jolla
  • Axis Clinical Trials /ID# 130390 - Los Angeles

Maryland

  • Investigative Clinical Research /ID# 119033 - Annapolis
  • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 119042 - Chevy Chase

Colorado

  • Rocky Mountain Gastroenterology /ID# 119038 - Wheat Ridge

Connecticut

  • Medical Research Ctr CT /ID# 119037 - Hamden

Trial Details

FieldValue
Enrollment Target 514 participants
Start Date 2014-05-01
Est. Completion 2020-01-30
Phase Phase 3

Sponsor

AbbVie

526 total trials

What the Registry Record Tells You About NCT02065570

The ClinicalTrials.gov registry entry for NCT02065570 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 514 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,390-participant average among 105 other Crohn's Disease trials with a reported enrollment target (78% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02065570 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Georgia, Illinois.

Frequently Asked Questions

What is clinical trial NCT02065570 about?

NCT02065570 is a clinical study titled "Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease". This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.

What is the current status of trial NCT02065570?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 514 participants. The study started on 2014-05-01. Estimated completion is 2020-01-30.

What conditions does trial NCT02065570 study?

This clinical trial studies the following conditions: Crohn's Disease.

What interventions are being tested in trial NCT02065570?

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

Who is sponsoring clinical trial NCT02065570?

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

Where is trial NCT02065570 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.