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

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 2,387-participant average among 105 other Crohn's Disease trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index score of greater than or equal (\>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of \> = 220 to less than or equal (\< =) 248 were considered to be in clinical response if a CDAI score of less than (\<) 150 was attained. A CDAI score of less than 150 indicates clinical remis

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
Janssen Research & Development

593 total trials

What the finished NCT01369329 record still lists

NCT01369329 is an interventional study that assigns participants to a tested intervention. The registered 769 participants enrollment target is mid-sized for trials with a published cap, below the 2,387-participant average among 105 other Crohn's Disease trials with a reported enrollment target (68% lower).

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 names 20 study sites across 10 states, led by 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.

Learn More About Clinical Trials

Similar trials for Crohn's Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01369329's enrollment target sits among peer trials

769 15th of 105 higher than 91 of 105 other Crohn's Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01369329, the US trial registry maintained by the National Library of Medicine. NCT01369329 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.