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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
526

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
      • 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
  • Austria
      • Innsbruck, Austria
      • Linz N/A, Austria
      • Salzburg, Austria
      • Wien, Austria
  • Belgium
      • Bonheiden, Belgium
      • Brussel, Belgium
      • Bruxelles, Belgium
      • Edegem, Belgium
      • Kortrijk, Belgium
      • Liege, Belgium
      • Louvain, Belgium
      • Roeselare, Belgium
  • Canada
      • 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
  • France
      • 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
  • Germany
      • 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
  • Israel
      • Afula, Israel
      • Beer Sheva, Israel
      • Haifa, Israel
      • Jerusalem, Israel
      • Kfar-Saba, Israel
      • Petah-Tikva, Israel
      • Tel Aviv, Israel
  • Netherlands
      • Amersfoort, Netherlands
      • Amsterdam, Netherlands
      • Leiden, Netherlands
      • Maastricht, Netherlands
      • Rotterdam, Netherlands
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
  • Spain
      • Barcelona, Spain
      • Cordoba, Spain
      • Leon N/A, Spain
      • Madrid, Spain
      • Oviedo, Spain
      • Palma De Mallorca N/A, Spain
      • Sabadell, Spain
      • Zaragoza, Spain
  • United Kingdom
      • 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
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo (IP)
Drug: Placebo (IP)
Induction phase (Week 0-8) (IP) - Placebo IV group
EXPERIMENTAL: Ustekinumab 1mg/kg (IP)
Drug: Ustekinumab 1mg/kg (IP)
Induction phase (Week 0-8) (IP) - Ustekinumab 1 mg/kg IV group
EXPERIMENTAL: Ustekinumab 3 mg/kg (IP)
Drug: Ustekinumab 3 mg/kg (IP)
Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
EXPERIMENTAL: Ustekinumab 6 mg/kg (IP)
Drug: Ustekinumab 6 mg/kg (IP)
Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
PLACEBO_COMPARATOR: Placebo IV - Responder - Placebo SC (MP)
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
PLACEBO_COMPARATOR: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC
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
PLACEBO_COMPARATOR: Ustekinumab IV - Responder - Placebo SC (MP)
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
EXPERIMENTAL: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)
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
PLACEBO_COMPARATOR: Ustekinumab IV - Nonresponder - Placebo SC (MP)
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
EXPERIMENTAL: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centocor, Inc.

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR015238
  • C0743T26 (OTHER: Centocor)

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.

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