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Crohn DiseasePhase 2NCT00265122

A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease

A Phase 2 study testing Ustekinumab 90 mg and Ustekinumab 4.5 mg/kg in people with Crohn Disease, run by Centocor, Inc. at 57 sites in 3 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

The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease
What is being tested?
Ustekinumab 90 mg and Ustekinumab 4.5 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
131 participants
Where
57 sitesin 3 countries
Study dates
Apr 2004to Oct 2006
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

  • Have moderately to severly active Crohn's disease or fistulizing Crohn's disease for at least 6 weeks' duration with a Crohn's disease activity index (CDAI) score of >=220 and <=450
  • In Population 1, participants must have had active disease despite treatment with 5-ASA compounds, antibiotics, corticosteroids, and/or immunomodulators, including anti-TNF agents. In Population 2, participants must have had active disease and have failed to respond to infliximab at the maximum approved dose and treatment regimen for Crohn's disease as defined in the US package insert.

Who cannot join

  • Have local manifestations of Crohn's disease such as strictures, abscesses, or other disease complications for which surgery might be indicated
  • Had intra-abdominal surgery within 6 months prior to entering the study
  • Have received treatment with parenteral nutrition (ie, introduction of nutrition into the body via a route other than the mouth) (total parenteral nutrition [TPN]) within 6 weeks of baseline

Trial locations and contacts

57 sites in 3 countries.

57 sites in 3 countries

United States50 sites

  • Study site

    Anaheim, California

  • Study site

    Austin, Texas

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Beaver Falls, Pennsylvania

  • Study site

    Bristol, Connecticut

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Charlottesville, Virginia

  • Study site

    Chesterfield, Michigan

  • Study site

    Christiansburg, Virginia

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Everett, Washington

  • Study site

    Germantown, Tennessee

  • Study site

    Great Neck, New York

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Knoxville, Tennessee

  • Study site

    Laurel, Maryland

  • Study site

    Lexington, Kentucky

  • Study site

    Louisville, Kentucky

  • Study site

    Madison, Wisconsin

  • Study site

    Memphis, Tennessee

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Nashville, Tennessee

  • Study site

    New Haven, Connecticut

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Ogden, Utah

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Providence, Rhode Island

  • Study site

    Richmond, Virginia

  • Study site

    Rochester, Minnesota

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Francisco, California

  • Study site

    Scottsdale, Arizona

  • Study site

    Seattle, Washington

  • Study site

    Tacoma, Washington

  • Study site

    Topeka, Kansas

  • Study site

    Troy, Michigan

Other trials in United States

Canada6 sites

  • Study site

    Edmonton, Alberta

  • Study site

    Hamilton

  • Study site

    London

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Belgium1 site

  • Study site

    Leuven

Other trials in Belgium

About this study

Official title: A Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects With Moderately to Severely Active Crohn's Disease

The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.

Read the detailed description

This is a multicenter, randomized study of IL-12p40 (CNTO 1275), hereafter referred to as ustekinumab, in 2 populations of participants with moderately to severely active Crohn's disease of at least 6 weeks duration. A total of approximately 120 volunteers will participate in this study in Canada, Belgium, and the United States. Two separate groups of participants (Population 1 and Population 2) will be evaluated. The primary population of participants (Population 1) will consist of approximately 100 participants with Crohn's disease despite treatment with standard Crohn's disease medications (includes agents to decrease intestinal inflammation such as 5-ASA medications such as PENTASA, ASACOL), corticosteroids such as prednisone and/or other drugs known to suppress the immune system called immunomodulators such as azathioprine, 6-mercaptopurine, methotrexate, infliximab or adalimumab [marketed under the trade name of HUMMIRA]). Participants in Population 1 will be randomly assigned (assigned by chance, like "flipping a coin") to double-blind treatment (participants and study staff will not know the identity of the treatments) with ustekinumab and placebo (inactive substance) in 1 of 4 treatment groups as follows: (1) 4 weeks of treatment with ustekinumab 90 mg followed by 4 weeks of treatment with placebo injected subcutaneously (SC, under the skin), (II) 4 weeks of placebo followed by 4 weeks of ustekinumab 90 mg injected SC, (III) 1 intravenous (IV, in the vein) infusion of ustekinumab 4.5 mg/kg followed by 1 IV infusion of placebo, and (IV) 1 IV infusion of placebo followed by 1 IV infusion of ustekinumab 4.5 mg/kg. Population 2 consists of approximately 20 participants who failed to respond to previous therapy with infliximab (trade name REMICADE), a type of antibody that decreases inflammation in patients with moderate to severe Crohn's disease). All participants in Population 2 will receive open-label (un-blinded) treatment with ustekinumab 4.5 mg/kg administered SC for 4 weeks or as one IV infusion. Placebo will not be given to participants in Population 2. The duration of the study for each participant is 28 weeks (not including a screening period of up to 2 weeks) with participants returning at Week 54 to have blood samples collected to assess the concentration of ustekinumab and antibodies to ustekinumab. Adverse events (side-effects) as a measure of safety and tolerability and results from routine laboratory tests will be monitored and reported throughout the study from the time that informed consent is documented up to 3 days after the final blood sample collection at Week 54. Note: doses of ustekinumab used in the study were adjusted by a factor of 0.9 to be consistent with the corrected absorptivity constant for ustekinumab. Therefore, ustekinumab doses of 100 mg and 5 mg/kg previously stated in the study protocol have been restated as 90 mg and 4.5 mg/kg, respectively. No change was made to the amount of ustekinumab given to participants in this study.

Conditions
Crohn Disease
Being tested
Ustekinumab 90 mg, Ustekinumab 4.5 mg/kg, Placebo SC, Placebo IV
Keywords
Crohn Disease, Biologic, Infusion, Injection, CNTO 1275, Ustekinumab, C01275, IL-12p40
Medical subject headings
Crohn Disease

What participants receive

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

  • Ustekinumab 90 mgDrug

    Also called CNTO 1275

    one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2)

  • Ustekinumab 4.5 mg/kgDrug

    Also called CNTO 1275

    one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in Intervention Period 1 or Week 8 in Intervention Period 2 for Population 1 or at Week 0 in Intervention Period 1 for Population 2

  • Placebo SCDrug

    one SC injection each week for 4 weeks (Weeks 0-3 in Intervention Period 1 or Weeks 8-11 in Intervention Period 2 for Population 1 or at Weeks 0-3 in Intervention Period 1 for Population 2)

  • Placebo IVDrug

    one IV infusion over a period of not less than 2 hours at Week 0 in Intervention Period 1 for Population 1 and Population 2 or at Week 8 in Intervention Period 2 for Population 1

Study groups in NCT00265122
Study groupRoleWhat they receive
Population 1: Placebo SC followed by ustekinumab SCExperimentalPlacebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
Receives: Drug: Ustekinumab 90 mg; Drug: Placebo SC
Population 1: Ustekinumab SC followed by Placebo SC:ExperimentalUstekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
Receives: Drug: Ustekinumab 90 mg; Drug: Placebo SC
Population 1: Placebo IV followed by ustekinumab IVExperimentalPlacebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
Receives: Drug: Ustekinumab 4.5 mg/kg; Drug: Placebo IV
Population 1: Ustekinumab IV followed by Placebo IV:ExperimentalUstekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
Receives: Drug: Ustekinumab 4.5 mg/kg; Drug: Placebo IV
Population 2: Ustekinumab SCExperimentalUstekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
Receives: Drug: Ustekinumab 90 mg
Population 2: Ustekinumab IVExperimentalUstekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
Receives: Drug: Ustekinumab 4.5 mg/kg

What is being measured

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

  1. Number of Participants in Population 1 With a Clinical Response at Week 8

    The table below provides the number of participants in Population 1 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well being. The primary endpoint analysis was based on the comparison between the combined SC and IV Placebo and combined SC and IV ustekinumab treatment groups in Population 1.

    Measured: Week 8

Secondary outcomes (2)

  1. Number of Participants in Population 2 With a Clinical Response at Week 8

    The table below provides the number of participants in Population 2 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.

    Measured: Week 8

  2. Number of Participants in Population 1 With Clinical Remission at Week 8

    The table below shows the number of participants in Population 1 with clinical remission at Week 8 defined a CDAI (Crohn's disease activity index) score < 150 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.

    Measured: Week 8

Timeline

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

  1. First posted14 Dec 2005 (estimated)
  2. Study startApr 2004
  3. Primary completionNov 2005
  4. Study completionOct 2006

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00265122
Sponsor's protocol ID
CR005287
Other IDs
C0379T07
Status last verified
Jan 2014
First submitted
13 Dec 2005
Last updated
13 Feb 2014
Data monitoring committee
No

Publications

  • 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

  • Sandborn WJ, Feagan BG, Fedorak RN, Scherl E, Fleisher MR, Katz S, Johanns J, Blank M, Rutgeerts P; Ustekinumab Crohn's Disease Study Group. A randomized trial of Ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn's disease. Gastroenterology. 2008 Oct;135(4):1130-41. doi: 10.1053/j.gastro.2008.07.014. Epub 2008 Jul 17.

    PubMed 18706417

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ustekinumab 90 mg and Ustekinumab 4.5 mg/kg in people with Crohn Disease, run by Centocor, Inc. at 57 sites in 3 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 2 inclusion and 3 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 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Canada, Belgium. 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. 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 31 Jul 2013). 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 in Population 1 With a Clinical Response at Week 8 (time frame: Week 8). 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 NCT00265122, which also lists 2 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 13 Feb 2014.

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