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

March 26, 2013 updated by: Centocor, Inc.

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

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 Overview

Detailed Description

In Crohn's disease there is inflammation (changes in body tissue which normally happen during injury or infection) and or ulceration (open sores) in the intestines.This occurs because the immune system (the part of the body that fights off infection) has an abnormal and overactive response against the intestine and bowel tissues of the body. Crohn's disease is usually treated with medications that either directly decrease inflammation or decrease the general activity of the immune system to improve the diarrhea, abdominal pain, and other symptoms of Crohn's Disease. Ustekinumab antibodies (natural substances made by your immune system to stick to and help remove foreign materials in your body that cause diseases) have been created to stick to and block the activity of two of the immune substances thought to cause abnormal inflammation of Crohn's disease. Patients who are eligible and who have received Remicade, Humira, or Cimzia and failed or been intolerant to one of these drugs will be randomized to either active drug (ustekinumab) or placebo. All patients will be randomized (like flipping a coin) at week 0 to be in one of 4 groups. At week 0 the study drug will be given by IV administration and at weeks 8 and 16 by subcutaneous injection. There will be 11 study visits in total and the study will continue until week 36. Blood and stool samples will be collected and studied, questionnaires to check on how you are doing in terms of your disease will be completed, an Electrocardiogram (EKG) obtained, safety evaluations conducted and diary cards distributed to be completed during the entire study. One of 4 groups: Grp 1-placebo, Grp 2-active drug 1mg/kg IV, Grp 3-active drug 3mg/kg IV, Grp 4-active drug 6mg/kg IV. Based on the clinical response status at Week 6, patients from Grps 2, 3 and 4 will be re-randomized at week 8 to receive either placebo or 90 mg SC at both weeks 8 and 16 and patients from Grp 1 will receive placebo at Week 8 and Week 16 or a 270 mg SC injection at Week 8 and 90 mg SC at Week 16.

Study Type

Interventional

Enrollment (Actual)

526

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Adelaide, Australia
      • Bankstown, Australia
      • Bedford Park, Australia
      • Box Hill, Australia
      • Concord, Australia
      • East Melbourne, Australia
      • Fitzroy, Australia
      • Frankston, Australia
      • Fremantle, Australia
      • Garran, Australia
      • Herston, Australia
      • Parkville, Australia
      • Prahran, Australia
      • South Brisbane, Australia
      • Innsbruck, Austria
      • Linz N/A, Austria
      • Salzburg, Austria
      • Wien, Austria
      • Bonheiden, Belgium
      • Brussel, Belgium
      • Bruxelles, Belgium
      • Edegem, Belgium
      • Kortrijk, Belgium
      • Liege, Belgium
      • Louvain, Belgium
      • Roeselare, Belgium
      • Quebec, Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
      • Amiens Cedex 1 80, France
      • Grenoble, France
      • Lille, France
      • Nice, France
      • Paris, France
      • Paris Cedex 10, France
      • Pessac, France
      • Rouen Cedex, France
      • Toulouse Cedex 9 N/A, France
      • Berlin, Germany
      • Berlin N/A, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Kiel, Germany
      • Leipzig, Germany
      • Lÿneburg, Germany
      • Markkleeberg, Germany
      • Minden, Germany
      • München, Germany
      • Münster, Germany
      • Regensburg, Germany
      • Afula, Israel
      • Beer Sheva, Israel
      • Haifa, Israel
      • Jerusalem, Israel
      • Kfar-Saba, Israel
      • Petah-Tikva, Israel
      • Tel Aviv, Israel
      • Amersfoort, Netherlands
      • Amsterdam, Netherlands
      • Leiden, Netherlands
      • Maastricht, Netherlands
      • Rotterdam, Netherlands
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Barcelona, Spain
      • Cordoba, Spain
      • Leon N/A, Spain
      • Madrid, Spain
      • Oviedo, Spain
      • Palma De Mallorca N/A, Spain
      • Sabadell, Spain
      • Zaragoza, Spain
      • Bristol, United Kingdom
      • Cambridge, United Kingdom
      • Coventry, United Kingdom
      • Edinburgh, United Kingdom
      • Harrow, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Newcastle Upon Tyne, United Kingdom
      • Norwich, United Kingdom
      • Nottinghamshirecc, United Kingdom
    • Alabama
      • Mobile, Alabama, United States
    • Arizona
      • Scottsdale, Arizona, United States
    • California
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • Roseville, California, United States
      • San Carlos, California, United States
      • San Francisco, California, United States
    • Colorado
      • Englewood, Colorado, United States
      • Lakewood, Colorado, United States
      • Littleton, Colorado, United States
    • Connecticut
      • Hamden, Connecticut, United States
    • Florida
      • Gainesville, Florida, United States
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Naples, Florida, United States
      • Panama City, Florida, United States
      • Pembroke Pines, Florida, United States
      • Port Charlotte, Florida, United States
      • Port Orange, Florida, United States
      • South Miami, Florida, United States
      • Tampa, Florida, United States
      • Vero Beach, Florida, United States
      • Winter Park, Florida, United States
      • Zephyrhills, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Columbus, Georgia, United States
      • Decatur, Georgia, United States
      • Macon, Georgia, United States
      • Newnan, Georgia, United States
    • Illinois
      • Arlington Heights, Illinois, United States
      • Chicago, Illinois, United States
      • Evanston, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Clive, Iowa, United States
    • Kansas
      • Pratt, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Chevy Chase, Maryland, United States
      • Towson, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Burlington, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Chesterfield, Michigan, United States
      • Detroit, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Mississippi
      • Ocean Springs, Mississippi, United States
    • Missouri
      • Mexico, Missouri, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Egg Harbor, New Jersey, United States
    • New York
      • Great Neck, New York, United States
      • New York, New York, United States
      • Ny, New York, United States
      • Poughkeepsie, New York, United States
      • Setauket, New York, United States
      • Stony Brook, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Greenville, North Carolina, United States
      • Kinston, North Carolina, United States
      • New Bern, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Beavercreek, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
      • Dayton, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Columbia, South Carolina, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Houston, Texas, United States
      • Lewisville, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Ogden, Utah, United States
      • Salt Lake City, Utah, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Norfolk, Virginia, United States
    • Washington
      • Bellevue, Washington, United States
      • Lakewood, Washington, United States
      • Seattle, Washington, United States
      • Tacoma, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have Crohn's disease or fistulizing Crohn's disease of at least 3 months duration
  • Must have received Remicade, adalimumab or Cimzia at a dose approved for the treatment of Crohn's disease
  • Must have failed or been intolerant to Remicade, Humira or Cimzia for treatment of Crohn's disease
  • Must be 18 years of age or older
  • Must have active Crohn's disease according to the Crohn's Disease Activity Index (CDAI > =220 and < =450).

Exclusion Criteria:

  • Patients who have had any kind of bowel resection, diversions or placement of a stoma within 6 months
  • Are pregnant, nursing or planning pregnancy (both men and women) while enrolled in the study or within 1 year after receiving study agent
  • Patients who have received Remicade, Humira or Cimzia < =8 weeks before the first administration of study drug
  • Patients with certain complications of Crohn's disease that would make it hard to assess response to study drug
  • Patients with a history of or ongoing chronic or recurrent infectious disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo (IP)
Induction phase (Week 0-8) (IP) - Placebo IV group
EXPERIMENTAL: Ustekinumab 1mg/kg (IP)
Induction phase (Week 0-8) (IP) - Ustekinumab 1 mg/kg IV group
EXPERIMENTAL: Ustekinumab 3 mg/kg (IP)
Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
EXPERIMENTAL: Ustekinumab 6 mg/kg (IP)
Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
PLACEBO_COMPARATOR: 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
PLACEBO_COMPARATOR: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC
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
PLACEBO_COMPARATOR: 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
EXPERIMENTAL: 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
PLACEBO_COMPARATOR: 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
EXPERIMENTAL: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Response at Week 6
Time Frame: Baseline to Week 6
As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.
Baseline to Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Remission at Week 6
Time Frame: Baseline to Week 6
As measured by a CDAI score of < 150 points.
Baseline to Week 6
Number of Participants With Clinical Response at Week 4
Time Frame: Baseline to Week 4
As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.
Baseline to Week 4
Number of Participants With Clinical Response at Week 8
Time Frame: Baseline to Week 8
As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.
Baseline to Week 8
Number of Participants With Clinical Remission at Week 8
Time Frame: Baseline to Week 8
As measured by a CDAI score of < 150 points.
Baseline to Week 8
Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)
Time Frame: Baseline to Week 22
As measured by a CDAI score of < 150 points.
Baseline to Week 22
Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)
Time Frame: Baseline to Week 22
As measured by the CDAI. Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of < 150 was attained.
Baseline to Week 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

October 10, 2008

First Submitted That Met QC Criteria

October 10, 2008

First Posted (ESTIMATE)

October 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 1, 2013

Last Update Submitted That Met QC Criteria

March 26, 2013

Last Verified

March 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn's Disease

Clinical Trials on Placebo (IP)

3
Subscribe