At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 131 enrolled

Drug / intervention

Ustekinumab 90 mg +3 moredrug

Likely dose

Ustekinumab 90 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00265122

NCT00265122Phase 2Completed

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A Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects With Moderately to Severely Active Crohn's Disease

Centocor, Inc.·interventional·Posted Dec 14, 2005·Updated Feb 13, 2014

In Brief

A Phase 2 clinical trial evaluating Ustekinumab 90 mg, Ustekinumab 4.5 mg/kg, and 2 other interventions for Crohn Disease. Completed, enrolled 131 participants across 57 sites in 3 countries.

Detailed Summary

The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCrohn Disease

CountriesBelgium, Canada, United States

Collaborators--

Timeline

Phase 2CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2004

Primary CompletionNov 2005

First PostedDec 2005

Study CompletionOct 2006

TodayJul 2026

First PostedDec 14, 2005

Enrollment StartApr 1, 2004

Primary CompletionNov 1, 2005

Study CompletionOct 1, 2006

TodayJul 2, 2026

Enrollment to primary: 1.6 yearsPosted 20.6 years ago

Interventions

Ustekinumab 90 mgdrug

one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2)

Ustekinumab 4.5 mg/kgdrug

one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in Intervention Period 1 or Week 8 in Intervention Period 2 for Population 1 or at Week 0 in Intervention Period 1 for Population 2

Placebo SCdrug

one SC injection each week for 4 weeks (Weeks 0-3 in Intervention Period 1 or Weeks 8-11 in Intervention Period 2 for Population 1 or at Weeks 0-3 in Intervention Period 1 for Population 2)

Placebo IVdrug

one IV infusion over a period of not less than 2 hours at Week 0 in Intervention Period 1 for Population 1 and Population 2 or at Week 8 in Intervention Period 2 for Population 1