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Crohn's DiseasePhase 2NCT00771667

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

A Phase 2 study testing Ustekinumab 1mg/kg (IP), Ustekinumab 3 mg/kg (IP) and Ustekinumab 6 mg/kg (IP) in people with Crohn's Disease, run by Centocor, Inc. at 174 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
Ustekinumab 1mg/kg (IP), Ustekinumab 3 mg/kg (IP) and Ustekinumab 6 mg/kg (IP)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
526 participants
Where
174 sitesin 12 countries
Study dates
Dec 2008to Dec 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

174 sites in 12 countries.

174 sites in 12 countries

United States88 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Arlington Heights, Illinois

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Beavercreek, Ohio

  • Study site

    Bellevue, Washington

  • Study site

    Boston, Massachusetts

  • Study site

    Burlington, Massachusetts

  • Study site

    Burlington, Vermont

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Charlottesville, Virginia

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chesterfield, Michigan

  • Study site

    Chevy Chase, Maryland

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Clive, Iowa

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Georgia

  • Study site

    Dayton, Ohio

  • Study site

    Decatur, Georgia

  • Study site

    Detroit, Michigan

  • Study site

    Egg Harbor, New Jersey

  • Study site

    Englewood, Colorado

  • Study site

    Evanston, Illinois

  • Study site

    Gainesville, Florida

  • Study site

    Great Neck, New York

  • Study site

    Greenville, North Carolina

  • Study site

    Hamden, Connecticut

  • Study site

    Hollywood, Florida

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Kinston, North Carolina

  • Study site

    La Jolla, California

  • Study site

    Lakewood, Colorado

  • Study site

    Lakewood, Washington

  • Study site

    Lebanon, New Hampshire

  • Study site

    Lewisville, Texas

  • Study site

    Lexington, Kentucky

  • Study site

    Littleton, Colorado

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Macon, Georgia

  • Study site

    Madison, Wisconsin

  • Study site

    Mexico, Missouri

  • Study site

    Miami, Florida

  • Study site

    Mobile, Alabama

  • Study site

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Bern, North Carolina

  • Study site

    New York, New York

  • Study site

    Newnan, Georgia

  • Study site

    Norfolk, Virginia

  • Study site

    Ocean Springs, Mississippi

  • Study site

    Ogden, Utah

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Panama City, Florida

  • Study site

    Pembroke Pines, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Port Charlotte, Florida

  • Study site

    Port Orange, Florida

  • Study site

    Poughkeepsie, New York

  • Study site

    Pratt, Kansas

  • Study site

    Raleigh, North Carolina

  • Study site

    Rochester, Minnesota

  • Study site

    Roseville, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Carlos, California

  • Study site

    San Francisco, California

  • Study site

    Scottsdale, Arizona

  • Study site

    Seattle, Washington

  • Study site

    Setauket, New York

  • Study site

    South Miami, Florida

  • Study site

    Stony Brook, New York

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Towson, Maryland

  • Study site

    Troy, Michigan

  • Study site

    Vero Beach, Florida

  • Study site

    Winter Park, Florida

  • Study site

    Worcester, Massachusetts

  • Study site

    Zephyrhills, Florida

Other trials in United States

Australia14 sites

  • Study site

    Adelaide

  • Study site

    Bankstown

  • Study site

    Bedford Park

  • Study site

    Box Hill

  • Study site

    Concord

  • Study site

    East Melbourne

  • Study site

    Fitzroy

  • Study site

    Frankston

  • Study site

    Fremantle

  • Study site

    Garran

  • Study site

    Herston

  • Study site

    Parkville

  • Study site

    Prahran

  • Study site

    South Brisbane

Other trials in Australia

Germany11 sites

  • Study site

    Berlin

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Kiel

  • Study site

    Leipzig

  • Study site

    Lÿneburg

  • Study site

    Markkleeberg

  • Study site

    Minden

  • Study site

    München

  • Study site

    Münster

  • Study site

    Regensburg

Other trials in Germany

Canada10 sites

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Hamilton, Ontario

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Victoria, British Columbia

Other trials in Canada

United Kingdom10 sites

  • Study site

    Bristol

  • Study site

    Cambridge

  • Study site

    Coventry

  • Study site

    Edinburgh

  • Study site

    Harrow

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Newcastle upon Tyne

  • Study site

    Norwich

  • Study site

    Nottinghamshirecc

Other trials in United Kingdom

France8 sites

  • Study site

    Amiens Cedex 1 80

  • Study site

    Grenoble

  • Study site

    Lille

  • Study site

    Nice

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Rouen

  • Study site

    Toulouse Cedex 9 N/A

Other trials in France

Spain8 sites

  • Study site

    Barcelona

  • Study site

    Córdoba

  • Study site

    León

  • Study site

    Madrid

  • Study site

    Oviedo

  • Study site

    Palma

  • Study site

    Sabadell

  • Study site

    Zaragoza

Other trials in Spain

Belgium7 sites

  • Study site

    Bonheiden

  • Study site

    Brussels

  • Study site

    Edegem

  • Study site

    Kortrijk

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Roeselare

Other trials in Belgium

Israel7 sites

  • Study site

    Afula

  • Study site

    Beersheba

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Kfar Saba

  • Study site

    Petah Tikva

  • Study site

    Tel Aviv

Other trials in Israel

Netherlands5 sites

  • Study site

    Amersfoort

  • Study site

    Amsterdam

  • Study site

    Leiden

  • Study site

    Maastricht

  • Study site

    Rotterdam

Other trials in Netherlands

Austria4 sites

  • Study site

    Innsbruck

  • Study site

    Linz

  • Study site

    Salzburg

  • Study site

    Vienna

Other trials in Austria

New Zealand2 sites

  • Study site

    Auckland

  • Study site

    Christchurch

Other trials in New Zealand

About this study

Official title: 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.

Read the 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.

Conditions
Crohn's Disease
Being tested
Placebo (IP), Ustekinumab 1mg/kg (IP), Ustekinumab 3 mg/kg (IP), Ustekinumab 6 mg/kg (IP), Placebo IV - Responder - Placebo SC (MP)
Keywords
Interleukin-12, Inflammation, Research study, Ustekinumab, CNTO1275, Interleukin-23
Medical subject headings
Crohn Disease, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo (IP)Drug

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

  • Ustekinumab 1mg/kg (IP)Drug

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

  • Ustekinumab 3 mg/kg (IP)Drug

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

  • Ustekinumab 6 mg/kg (IP)Drug

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

  • Placebo IV - Responder - Placebo SC (MP)Drug

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

    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

  • Ustekinumab IV - Responder - Placebo SC (MP)Drug

    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

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

    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

  • Ustekinumab IV - Nonresponder - Placebo SC (MP)Drug

    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

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

    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

Study groups in NCT00771667
Study groupRoleWhat they receive
Placebo (IP)Placebo comparatorNot described
Receives: Drug: Placebo (IP)
Ustekinumab 1mg/kg (IP)ExperimentalNot described
Receives: Drug: Ustekinumab 1mg/kg (IP)
Ustekinumab 3 mg/kg (IP)ExperimentalNot described
Receives: Drug: Ustekinumab 3 mg/kg (IP)
Ustekinumab 6 mg/kg (IP)ExperimentalNot described
Receives: Drug: Ustekinumab 6 mg/kg (IP)
Placebo IV - Responder - Placebo SC (MP)Placebo comparatorNot described
Receives: Drug: Placebo IV - Responder - Placebo SC (MP)
Placebo IV - Nonresponder - Ustekinumab 270/90 mg SCPlacebo comparatorNot described
Receives: Drug: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP)
Ustekinumab IV - Responder - Placebo SC (MP)Placebo comparatorNot described
Receives: Drug: Ustekinumab IV - Responder - Placebo SC (MP)
Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)ExperimentalNot described
Receives: Drug: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)
Ustekinumab IV - Nonresponder - Placebo SC (MP)Placebo comparatorNot described
Receives: Drug: Ustekinumab IV - Nonresponder - Placebo SC (MP)
Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)ExperimentalNot described
Receives: Drug: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Clinical Response at 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.

    Measured: Baseline to Week 6

Secondary outcomes (6)

  1. Number of Participants With Clinical Remission at Week 6

    As measured by a CDAI score of < 150 points.

    Measured: Baseline to Week 6

  2. Number of Participants With Clinical Response at 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.

    Measured: Baseline to Week 4

  3. Number of Participants With Clinical Response at 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.

    Measured: Baseline to Week 8

  4. Number of Participants With Clinical Remission at Week 8

    As measured by a CDAI score of < 150 points.

    Measured: Baseline to Week 8

  5. Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)

    As measured by a CDAI score of < 150 points.

    Measured: Baseline to Week 22

  6. Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)

    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.

    Measured: Baseline to Week 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionMay 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
526 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00771667
Sponsor's protocol ID
CR015238
Other IDs
C0743T26
Status last verified
Mar 2013
First submitted
10 Oct 2008
Last updated
1 Apr 2013
Data monitoring committee
Yes

Publications

  • Adedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21.

    PubMed 36150926

  • Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3.

    PubMed 30739254

  • Di Narzo AF, Telesco SE, Brodmerkel C, Argmann C, Peters LA, Li K, Kidd B, Dudley J, Cho J, Schadt EE, Kasarskis A, Dobrin R, Hao K. High-Throughput Characterization of Blood Serum Proteomics of IBD Patients with Respect to Aging and Genetic Factors. PLoS Genet. 2017 Jan 27;13(1):e1006565. doi: 10.1371/journal.pgen.1006565. eCollection 2017 Jan.

    PubMed 28129359

  • Sandborn WJ, Gasink C, Gao LL, Blank MA, Johanns J, Guzzo C, Sands BE, Hanauer SB, Targan S, Rutgeerts P, Ghosh S, de Villiers WJ, Panaccione R, Greenberg G, Schreiber S, Lichtiger S, Feagan BG; CERTIFI Study Group. Ustekinumab induction and maintenance therapy in refractory Crohn's disease. N Engl J Med. 2012 Oct 18;367(16):1519-28. doi: 10.1056/NEJMoa1203572.

    PubMed 23075178

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ustekinumab 1mg/kg (IP), Ustekinumab 3 mg/kg (IP) and Ustekinumab 6 mg/kg (IP) in people with Crohn's Disease, run by Centocor, Inc. at 174 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 174 sites in United States, Australia, Germany, Canada, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinical Response at Week 6 (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00771667, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2013.

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