A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease
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
2 other identifiers
interventional
131
3 countries
57
Brief Summary
The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2004
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 13, 2005
CompletedFirst Posted
Study publicly available on registry
December 14, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedResults Posted
Study results publicly available
July 31, 2013
CompletedFebruary 13, 2014
January 1, 2014
1.6 years
December 13, 2005
October 23, 2009
January 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Week 8
Secondary Outcomes (2)
Number of Participants in Population 2 With a Clinical Response at Week 8
Week 8
Number of Participants in Population 1 With Clinical Remission at Week 8
Week 8
Study Arms (6)
Population 1: Placebo SC followed by ustekinumab SC
EXPERIMENTALPlacebo 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.
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.
Population 1: Placebo IV followed by ustekinumab IV
EXPERIMENTALPlacebo 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.
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.
Population 2: Ustekinumab SC
EXPERIMENTALUstekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
Population 2: Ustekinumab IV
EXPERIMENTALUstekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
Interventions
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)
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
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)
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
Study Sites (57)
Unknown Facility
Scottsdale, Arizona, United States
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Anaheim, California, United States
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Sacramento, California, United States
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San Francisco, California, United States
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Bristol, Connecticut, United States
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New Haven, Connecticut, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Indianapolis, Indiana, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Laurel, Maryland, United States
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Chesterfield, Michigan, United States
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Troy, Michigan, United States
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Rochester, Minnesota, United States
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Omaha, Nebraska, United States
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Great Neck, New York, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Beaver Falls, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Columbia, South Carolina, United States
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Germantown, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Christiansburg, Virginia, United States
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Richmond, Virginia, United States
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Everett, Washington, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Leuven, Belgium
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Toronto, Ontario, Canada
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Hamilton, Canada
Unknown Facility
London, Canada
Related Publications (2)
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.
PMID: 30739254DERIVEDSandborn 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.
PMID: 18706417DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in \<=5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.
Results Point of Contact
- Title
- Sr. Dir. Clinical Research
- Organization
- Centocor Research & Development, Inc.
Study Officials
- STUDY DIRECTOR
Centocor Clinical Trial
Centocor, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2005
First Posted
December 14, 2005
Study Start
April 1, 2004
Primary Completion
November 1, 2005
Study Completion
October 1, 2006
Last Updated
February 13, 2014
Results First Posted
July 31, 2013
Record last verified: 2014-01