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NCT00055497 · ClinicalTrials.gov registry record · Phase 3

Remission in Subjects With Crohn's Disease, 1 Year Phase

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

Completed
Registry status
Phase 3
Development phase
276
Enrollment target
20
Study locations

NCT00055497 is a Phase 3 study of Crohn's Disease that has completed, run by Abbott. The registered enrollment target is 276 participants, below the 2,412-participant average among 104 other Crohn's Disease trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT00055497, a Phase 3 study of Crohn's Disease, has completed, sponsored by Abbott.

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

Study Summary

The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of clinical remission up to 56 weeks in participants with Crohn's disease who participated in NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with Crohn's disease up to 56 weeks.

Conditions Studied

Crohn's Disease

Interventions

  • BIOLOGICAL Double-blind (DB) adalimumab placebo
  • BIOLOGICAL DB adalimumab 40 mg eow
  • BIOLOGICAL DB adalimumab 40 mg ew
  • BIOLOGICAL OL adalimumab 40 mg

Study Locations (20)

California

  • Gastroenterology Associates of the East Bay - Berkeley
  • Long Beach Gastroenterology Assoc. - Long Beach
  • Sharp Rees-Stealy Medical Group - San Diego

Florida

  • Cleveland Clinic Florida - Weston
  • Wake Research Associates - Weston
  • Shafran Gastroenterology Center - Winter Park

Massachusetts

  • Massachusetts General Hospital - Boston
  • Brigham and Women's Hospital - Boston
  • Clinical Pharmacology Study Group - Worchester

Georgia

  • Atlanta Gastroenterology Assoc. - Atlanta
  • Southeastern Digestive & Liver Disease - Savannah

Illinois

  • Northwest Gastroenterologists, S.C. - Arlington Heights
  • University of Chicago - Chicago

Louisiana

  • Drug Research Services, Inc. - Metairie
  • LSU School of Medicine - New Orleans

Missouri

  • Gastroenterology and Hepatology - Kansas City
  • Glenn Gordon, MD - Mexico

Connecticut

  • Gastroenterology Assoc. of Fairfield Co. - Bridgeport

Trial Details

FieldValue
Enrollment Target 276 participants
Start Date 2002-08
Est. Completion 2008-12
Phase Phase 3

Sponsor

Abbott

181 total trials

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What the Registry Record Tells You About NCT00055497

The ClinicalTrials.gov registry entry for NCT00055497 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,412-participant average among 104 other Crohn's Disease trials with a reported enrollment target (89% 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 4 interventions - of which Double-blind (DB) adalimumab placebo is the first listed.

NCT00055497 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00055497 about?

NCT00055497 is a clinical study titled "Remission in Subjects With Crohn's Disease, 1 Year Phase". The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of clinical remission up to 56 weeks in participants with Crohn's disease who participated in NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with Crohn's disease up to 56 w...

What is the current status of trial NCT00055497?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2002-08. Estimated completion is 2008-12.

What conditions does trial NCT00055497 study?

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

What interventions are being tested in trial NCT00055497?

The interventions under investigation include: Double-blind (DB) adalimumab placebo (BIOLOGICAL), DB adalimumab 40 mg eow (BIOLOGICAL), DB adalimumab 40 mg ew (BIOLOGICAL), OL adalimumab 40 mg (BIOLOGICAL).

Who is sponsoring clinical trial NCT00055497?

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

Where is trial NCT00055497 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Georgia, Illinois. 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.