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NCT01369329 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)

A Phase 3 study of Crohn's Disease and Inflammatory Bowel Disease, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 3
Development phase
769
Enrollment target
20
Study locations

NCT01369329 is a Phase 3 study of Crohn's Disease and Inflammatory Bowel Disease that has completed, run by Janssen Research & Development. The registered enrollment target is 769 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 10 states.

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The verdict

NCT01369329, a Phase 3 study of Crohn's Disease and Inflammatory Bowel Disease, has completed, sponsored by Janssen Research & Development.

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

Study Summary

This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol).

Conditions Studied

Crohn's Disease Inflammatory Bowel Disease IBD Colitis

Interventions

  • DRUG Group 2 ustekinumab 130 mg
  • DRUG Group 3: ustekinumab approximately 6 mg/kg
  • DRUG Group 1: Placebo

Study Locations (20)

California

  • - La Jolla
  • - Los Angeles
  • - Redwood City
  • - San Carlos
  • - San Diego

Florida

  • - Gainesville
  • - Jacksonville
  • - Weston
  • - Winter Park

Georgia

  • - Atlanta
  • - Decatur
  • - Macon

Illinois

  • - Chicago
  • - Evanston

Arizona

  • - Tucson

Arkansas

  • - Little Rock

Colorado

  • - Lone Tree

Connecticut

  • - New Haven

Trial Details

FieldValue
Enrollment Target 769 participants
Start Date 2011-07
Est. Completion 2013-07
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01369329

The ClinicalTrials.gov registry entry for NCT01369329 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 769 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 Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Crohn's Disease appearing as the primary indexed condition, and to 3 interventions - of which Group 2 ustekinumab 130 mg is the first listed.

NCT01369329 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT01369329 about?

NCT01369329 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)". This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past...

What is the current status of trial NCT01369329?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 769 participants. The study started on 2011-07. Estimated completion is 2013-07.

What conditions does trial NCT01369329 study?

This clinical trial studies the following conditions: Crohn's Disease, Inflammatory Bowel Disease, IBD, Colitis.

What interventions are being tested in trial NCT01369329?

The interventions under investigation include: Group 2 ustekinumab 130 mg (DRUG), Group 3: ustekinumab approximately 6 mg/kg (DRUG), Group 1: Placebo (DRUG).

Who is sponsoring clinical trial NCT01369329?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01369329 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. 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.