A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy

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.

Conditions

• Crohn's Disease

Interventions

DRUG

Placebo (IP)

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

DRUG

Ustekinumab 1mg/kg (IP)

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

DRUG

Ustekinumab 3 mg/kg (IP)

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

DRUG

Ustekinumab 6 mg/kg (IP)

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

DRUG

Placebo IV - Responder - Placebo SC (MP)

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

DRUG

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

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

DRUG

Ustekinumab IV - Responder - Placebo SC (MP)

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

DRUG

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

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

DRUG

Ustekinumab IV - Nonresponder - Placebo SC (MP)

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

DRUG

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

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

Sponsors & Collaborators

• Centocor, Inc.

  lead INDUSTRY

Principal Investigators

• Centocor, Inc. Clinical Trial · Centocor, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-12-31

Primary Completion

2010-05-31

Completion

2010-12-31

Countries

• United States
• Australia
• Austria
• Belgium
• Canada
• France
• Germany
• Israel
• Netherlands
• New Zealand
• Spain
• United Kingdom

Study Locations