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NCT00195715 · ClinicalTrials.gov registry record · Phase 3

Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease

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

Completed
Registry status
Phase 3
Development phase
777
Enrollment target
20
Study locations

NCT00195715 is a Phase 3 study of Crohn's Disease that has completed, run by Abbott. The registered enrollment target is 777 participants, below the 2,407-participant average among 104 other Crohn's Disease trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT00195715, a Phase 3 study of Crohn's Disease, has completed, sponsored by Abbott.

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

Study Summary

To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

Conditions Studied

Interventions

  • BIOLOGICAL Adalimumab

Study Locations (20)

Florida

  • Site Ref # / Investigator 1827 - Clearwater
  • Site Ref # / Investigator 1883 - Gainesville
  • Site Ref # / Investigator 1909 - Hollywood
  • Site Ref # / Investigator 1884 - Ormond Beach
  • Site Ref # / Investigator 1786 - Winter Park

California

  • Site Ref # / Investigator 1787 - La Jolla
  • Site Ref # / Investigator 1902 - Roseville
  • Site Ref # / Investigator 1824 - San Diego
  • Site Ref # / Investigator 1891 - San Diego

Colorado

  • Site Ref # / Investigator 1860 - Englewood
  • Site Ref # / Investigator 6178 - Lone Tree
  • Site Ref # / Investigator 1904 - Wheat Ridge

Illinois

  • Site Ref # / Investigator 1878 - Arlington Heights
  • Site Ref # / Investigator 2534 - Chicago
  • Site Ref # / Investigator 1823 - Peoria

Alabama

  • Site Ref # / Investigator 1894 - Huntsville
  • Site Ref # / Investigator 1895 - Jacksonville

Connecticut

  • Site Ref # / Investigator 1858 - Bridgeport

Georgia

  • Site Ref # / Investigator 1912 - Atlanta

Indiana

  • Site Ref # / Investigator 1885 - Anderson

Trial Details

FieldValue
Enrollment Target 777 participants
Start Date 2004-09
Est. Completion 2008-12
Phase Phase 3

Sponsor

Abbott

181 total trials

What the Registry Record Tells You About NCT00195715

The ClinicalTrials.gov registry entry for NCT00195715 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 777 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,407-participant average among 104 other Crohn's Disease trials with a reported enrollment target (68% lower). The listed sponsor is Abbott, which has 181 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 1 intervention - of which Adalimumab is the first listed.

NCT00195715 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT00195715 about?

NCT00195715 is a clinical study titled "Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease". To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with Crohn's disease who participated in and successfully completed Protocol M02-404 or Protocol M04-691.

What is the current status of trial NCT00195715?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 777 participants. The study started on 2004-09. Estimated completion is 2008-12.

What conditions does trial NCT00195715 study?

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

What interventions are being tested in trial NCT00195715?

The interventions under investigation include: Adalimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00195715?

This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00195715 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.

Similar trials for Crohn's Disease

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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.