CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 526 enrolled
Drug / intervention
Placebo (IP) +9 moredrug
Likely dose
Ustekinumab 1mg/kg (IP)from 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/NCT00771667
NCT00771667Phase 2Completed
CompareCT.gov

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy

Centocor, Inc.·interventional·Posted Oct 13, 2008·Updated Apr 1, 2013

In Brief

A Phase 2 clinical trial evaluating Placebo (IP), Ustekinumab 1mg/kg (IP), and 8 other interventions for Crohn's Disease. Completed, enrolled 526 participants across 174 sites in 12 countries.

Detailed Summary

A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Israel, Netherlands, New Zealand, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 13, 2008
Enrollment StartDec 1, 2008
Primary CompletionMay 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.7 years ago

Interventions

Placebo (IP)drug

Induction phase (Week 0-8) (IP) - Placebo IV group

Ustekinumab 1mg/kg (IP)drug

Induction phase (Week 0-8) (IP) - Ustekinumab 1 mg/kg IV group

Ustekinumab 3 mg/kg (IP)drug

Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group

Ustekinumab 6 mg/kg (IP)drug

Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group

Placebo IV - Responder - Placebo SC (MP)drug

Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16

Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP)drug

Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16

Ustekinumab IV - Responder - Placebo SC (MP)drug

Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Placebo SC at Week 8 and Week 16

Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)drug

Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Responder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16

Ustekinumab IV - Nonresponder - Placebo SC (MP)drug

Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Placebo SC at Week 8 and Week 16

Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)drug

Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 - Nonresponder at week 6 - Receiving Ustekinumab 90 mg SC at Week 8 and Week 16