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A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)

NCT01369355 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1282

Last updated 2025-02-04

Study results available
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Summary

The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.

Conditions

Interventions

DRUG

Placebo SC

Placebo will be administered subcutaneously.

DRUG

Placebo IV

Placebo will be administered as a single Intravenous infusion at week 0.

DRUG

Ustekinumab 90 mg SC q8w

Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.

DRUG

Ustekinumab 130 mg IV

Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.

DRUG

Ustekinumab 90 mg SC q12w

Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-13
Primary Completion
2015-06-10
Completion
2019-10-01

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Iceland
  • Ireland
  • Israel
  • Japan
  • Netherlands
  • New Zealand
  • Poland
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01369355 on ClinicalTrials.gov