A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)

October 14, 2016 updated by: Janssen Research & Development, LLC

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)

This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study (CNTO1275CRD3001 or "UNITI-1") examines ustekinumab (an antibody medication that inhibits the inflammatory proteins IL-12 and IL-23) versus a placebo (otherwise identical except without the ustekinumab antibody) given intravenously (by an IV) in adults with moderately to severely active Crohn's disease who previously did not respond to, lost response to, or could not tolerate TNF-antagonist medications (specifically, infliximab, adalimumab or certolizumab pegol). Ustekinumab (also known as Stelara) is approved as a treatment for the skin condition of moderate to severe plaque-type psoriasis, but this study will examine if ustekinumab can provide benefit in Crohn's disease and also assess for any risks or side effects. Both the positive and negative outcomes of IV placebo versus two different doses of IV ustekinumab will be tracked and compared over eight weeks, in approximately 703 patients. Patients enrolling in this study will be assigned to one of the 3 treatment groups by chance (randomly, like rolling dice), and all will receive a single IV administration of study agent at the first study visit (after the screening period), and then will be asked to return for 3 additional visits through Week 8. Patients who complete this study through the Week 8 visit and remain eligible can enter the maintenance study (CNTO1275CRD3003 or "IM-UNITI'' [NCT01369355]), where they will receive additional study agent, including the administration of ustekinumab in patients who receive placebo in this study and have not had improvement in their Crohn's disease. Patients who do not enter the CNTO1275CRD3003 study will have a final safety follow-up visit approximately 20 weeks after they received study agent when they entered into this study at the Week 0 visit. .All patients will receive a single intravenous (IV) administration of study drug (either placebo or ustekinumab) at the first (week 0) visit when they enter the study.There are 3 treatment groups: Group 1: Placebo; Group 2: ustekinumab 130 mg, Group 3: weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg), 390 mg (weight > 55 kg and <= 85 kg), and 520 mg (weight > 85 kg).

Study Type

Interventional

Enrollment (Actual)

769

Phase

  • Phase 3

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
      • Bedford Park, Australia
      • Box Hill, Australia
      • Central Queensland M C, Australia
      • Concord, Australia
      • Garran, Australia
      • Liverpool, Australia
      • Malvern, Australia
      • Parkville, Australia
  • Austria
      • Innsbruck, Austria
      • St Poelten, Austria
      • Wien, Austria
  • Belgium
      • Brussel, Belgium
      • Leuven, Belgium
      • Liege, Belgium
  • Brazil
      • Rio De Janeiro, Brazil
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Brandon, Manitoba, Canada
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kingston, Ontario, Canada
      • London, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Czech Republic
      • Hradec Kralove, Czech Republic
      • Usti Nad Labem, Czech Republic
  • Denmark
      • Herlev, Denmark
      • Silkeborg, Denmark
  • France
      • Amiens Cedex 1, France
      • Caen, France
      • Lille, France
      • Marseille, France
      • Nantes Cedex 1, France
      • Paris, France
      • Paris Cedex 18, France
      • Pessac, France
      • Reims, France
      • Rouen, France
      • Toulouse, France
  • Germany
      • Berlin, Germany
      • Erlangen, Germany
      • Essen, Germany
      • Frankfurt, Germany
      • Freiburg, Germany
      • Halle, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Heidelberg, Germany
      • Jena, Germany
      • Kiel, Germany
      • Lÿneburg, Germany
      • Mannheim, Germany
      • Minden, Germany
      • München, Germany
      • Münster, Germany
      • Regensburg, Germany
      • Tübingen, Germany
      • Ulm, Germany
  • Hungary
      • Szekszard, Hungary
  • Iceland
      • Akureyri, Iceland
      • Reykjavik, Iceland
  • Ireland
      • Dublin, Ireland
      • Dublin 9, Ireland
  • Israel
      • Jerusalem, Israel
      • Tel Hashomer, Israel
  • Japan
      • Chikushino, Japan
      • Fukuoka, Japan
      • Hamamatsu, Japan
      • Kagoshima, Japan
      • Nishinomiya, Japan
      • Ohtsu, Japan
      • Oita, Japan
      • Osaka, Japan
      • Sakura, Japan
      • Sapporo, Japan
      • Tokyo, Japan
      • Yokkaichi, Japan
  • Korea, Republic of
      • Seoul, Korea, Republic of
  • Netherlands
      • Amsterdam, Netherlands
      • Maastricht, Netherlands
      • Rotterdam, Netherlands
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Grafton, New Zealand
      • Hamilton, New Zealand
  • Poland
      • Krakow, Poland
      • Lodz, Poland
  • Serbia
      • Belgrade, Serbia
      • Nis, Serbia
  • South Africa
      • Cape Town, South Africa
      • Overport, South Africa
  • Spain
      • Madrid, Spain
      • Sagunto, Spain
  • United Kingdom
      • Birmingham, United Kingdom
      • Brighton, United Kingdom
      • Bristol, United Kingdom
      • Cambridge, United Kingdom
      • Cardiff, United Kingdom
      • Exeter, United Kingdom
      • Gloucester, United Kingdom
      • Harrow, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Norwich, United Kingdom
      • Nottinghamshirecc, United Kingdom
      • Oxford, United Kingdom
      • Shropshire, United Kingdom
      • South Shields, United Kingdom
      • Southampton, United Kingdom
  • United States
    • Arizona
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • Redwood City, California, United States
      • San Carlos, California, United States
      • San Diego, California, United States
    • Colorado
      • Lone Tree, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Florida
      • Gainesville, Florida, United States
      • Jacksonville, Florida, United States
      • Weston, Florida, United States
      • Winter Park, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Decatur, Georgia, United States
      • Macon, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Evanston, Illinois, United States
    • Iowa
      • Clive, Iowa, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Chevy Chase, Maryland, United States
      • Towson, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Chesterfield, Michigan, United States
      • Novi, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Mississippi
      • Ocean Springs, Mississippi, United States
    • Missouri
      • Lees Summit, Missouri, United States
      • Urbana, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Marlton, New Jersey, United States
      • Morristown, New Jersey, United States
    • New York
      • Great Neck, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Beavercreek, Ohio, United States
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Bend, Oregon, United States
      • Springfield, Oregon, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • North Charleston, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Houston, Texas, United States
      • Tyler, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Chesapeake, Virginia, United States
      • Norfolk, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Seattle, 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:

  • Have Crohn's disease of at least 3 months' duration with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, or endoscopy
  • Have active Crohn's disease, defined as a baseline Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450
  • Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for the treatment of Crohn disease and did not respond initially (ie, primary nonresponse)
  • Or responded initially but then lost response with continued therapy (ie, secondary nonresponse)
  • Or were intolerant to the medication
  • Have screening laboratory test results within protocol-specified parameters.

Exclusion Criteria:

  • Patients who have had any kind of bowel resection within 6 months
  • Are pregnant or planning pregnancy (both men and women) while enrolled in the study or for 20 weeks after receiving study agent
  • Patients who have received infliximab, adalimumab or certolizumab pegol < = 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
  • Patients who have previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874)

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 001
Group 1: Placebo Form=solution for injection route=intravenous use in a single dose.
Drug: Group 1: Placebo
Form=solution for injection, route=intravenous use, in a single dose.
Experimental: 002
Group 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose.
Drug: Group 2 ustekinumab 130 mg
Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.
Experimental: 003
Group 3: ustekinumab approximately 6 mg/kg Type=range unit=mg/kg number=6 form=solution for injection route= intravenous use in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg) 390 mg (weight > 55 kg and <= 85 kg) and 520 mg (weight > 85 kg).
Drug: Group 3: ustekinumab approximately 6 mg/kg
Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg), 390 mg (weight > 55 kg and <= 85 kg), and 520 mg (weight > 85 kg).

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 and Week 6
Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.
Baseline and Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants in Clinical Remission at Week 8
Time Frame: Baseline and Week 8
Clinical remission is defined as a CDAI score of less than (<) 150 points at Week 8.
Baseline and Week 8
Number of Participants in Clinical Response at Week 8
Time Frame: Baseline and Week 8
Clinical response at Week 8 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.
Baseline and Week 8
Number of Participants With Crohn's Disease Activity Index (CDAI) 70-point Response at Week 6
Time Frame: Baseline and Week 6
70-point response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline and Week 6
Number of Participants With CDAI 70-point Response at Week 3
Time Frame: Baseline and Week 3
70-point response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
Baseline and Week 3

Collaborators and Investigators

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

Sponsor

Janssen Research & Development, LLC

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

July 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR018415
  • CNTO1275CRD3001 (Other Identifier: Janssen Research & Development, LLC)
  • 2010-022758-18 (EudraCT Number)

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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