- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00488774
An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis
April 29, 2013 updated by: Janssen Research & Development, LLC
A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
This is a randomized (study medication assigned by chance), double-blind (neither the Physician nor the participant know about the study medication), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions [treatments]) study to evaluate an appropriate intravenous (through a vein in the arm) golimumab induction dose and to demonstrate the safety and efficacy of intravenous induction dosing with golimumab in participants with moderately to severely active UC.
At Week 6, participants will be asked to participate in an additional 1-year maintenance study.
Participants not entering the 1-year golimumab maintenance study will be evaluated for safety at Week 16.
The duration of study will be 6 weeks for participants who enter the 1-year golimumab maintenance study and 16 weeks for participant who do not enter the 1-year golimumab maintenance study.There are 2 parts in this study.
Part 1 is Phase 2 "dose-ranging" portion of study.
Participants enrolled in Part 1, will receive a single intravenous infusion of either matching placebo for golimumab or 1 milligram (mg) per kilogram(kg), 2 mg per kg or 4 mg per kg of golimumab.
Part 2 of the study is called "dose-confirming" and newly enrolled participants will receive same doses studied in Part 1, until the doses for Part 2 are selected and Phase 3 begins.
At the time that the final doses are selected, all newly enrolled participants will receive 1 of the selected doses or matching placebo; this is the start of the Phase 3 portion of the study.
Participants will primarily be assessed using Mayo Score (it is a score developed for measuring disease activity).
Participants' safety and quality of life will also be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
291
Phase
- Phase 2
- 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
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Adelaide, Australia
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Brisbane, Australia
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Malvern, Australia
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Innsbruck N/A, Austria
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Bonheiden, Belgium
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Leuven, Belgium
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Rousse, Bulgaria
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Varna, Bulgaria
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Alberta
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Calgary, Alberta, Canada
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British Columbia
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Ontario
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Quebec
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Montreal, Quebec, Canada
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
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Clichy, France
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Lille Cedex, France
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Nice Cedex 3, France
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Berlin, Germany
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Herne, Germany
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Magdeburg, Germany
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HH
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Hamburg, HH, Germany
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Budapest N/A, Hungary
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Békéscsaba, Hungary
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Gyulai Ut 18, Hungary
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Gyõr, Hungary
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Miskolc, Hungary
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Miskolc N/A, Hungary
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Pécs, Hungary
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Szekesfehervar, Hungary
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Szombathely, Hungary
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Hyderabad Andh Prad, India
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Jaipur, India
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Lucknow, India
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Ludhiana, India
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Pune, India
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Afula, Israel
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Hedera, Israel
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Jerusalem, Israel
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Kfar Sava, Israel
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Tel-Aviv, Israel
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Daugavpils, Latvia
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Riga, Latvia
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Klaipeda, Lithuania
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Siauliai, Lithuania
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Vilnius LT, Lithuania
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Amsterdam, Netherlands
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Groningen, Netherlands
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Leiden, Netherlands
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Rotterdam, Netherlands
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Auckland, New Zealand
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Hastings, New Zealand
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Bialystok N/A, Poland
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Czestochowa, Poland
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Krakow, Poland
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Krakow N/A, Poland
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Lodz, Poland
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Skierniewice, Poland
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Sopot, Poland
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Bucuresti, Romania
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Timisoara, Romania
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Moscow, Russian Federation
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St.Petersburg, Russian Federation
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Yaroslavl, Russian Federation
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Belgrade, Serbia
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Beograd, Serbia
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Bratislava, Slovakia
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Nitra, Slovakia
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Presov, Slovakia
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Göteborg, Sweden
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Donetsk, Ukraine
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Ivano, Ukraine
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Kiev, Ukraine
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Vynnytsya, Ukraine
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California
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Orange, California, United States
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Roseville, California, United States
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Colorado
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Littleton, Colorado, United States
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Connecticut
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Bristol, Connecticut, United States
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Florida
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Tampa, Florida, United States
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Iowa
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Fort Dodge, Iowa, United States
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Kansas
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Topeka, Kansas, United States
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Kentucky
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Louisville, Kentucky, United States
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Maryland
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Laurel, Maryland, United States
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Michigan
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Dearborn, Michigan, United States
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Troy, Michigan, United States
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Missouri
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Mexico, Missouri, United States
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St. Louis, Missouri, United States
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New Hampshire
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Lebanon, New Hampshire, United States
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New York
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Great Neck, New York, United States
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Huntington, New York, United States
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New York, New York, United States
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North Carolina
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Charlotte, North Carolina, United States
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Kinston, North Carolina, United States
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Ohio
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Tennessee
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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Austin, Texas, United States
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Galveston, Texas, United States
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Vermont
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Burlington, Vermont, United States
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Virginia
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Christiansburg, Virginia, United States
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Richmond, Virginia, United States
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Washington
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Bellevue, Washington, United States
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Wisconsin
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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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:
- Participants diagnosed with moderately to severely active ulcerative colitis (UC) defined by a Mayo score of 6 to 12 inclusive at Baseline (Week 0), including an endoscopic (examination of an internal part of the body with a lighted tube; looking at a part of the body with a lighted tube) subscore of greater than or equal to 2
- Participants must have biopsy results (collected at the screening endoscopy (procedure or obtained within the last year) consistent with the diagnosis of UC
- Participants either currently receiving treatment with, or have a history of failure to respond to, or tolerate, at least 1 of the following therapies: oral 5-aminosalicylate (5-ASAs), oral corticosteroids, 6-mercaptopurine (6-MP) and azathioprine (AZA)
- Participants with current dependency or with a history of corticosteroid dependency (i.e. an inability to successfully taper corticosteroids without a return of the symptoms of UC) - Not have a diagnosis of active TB
Exclusion Criteria:
- Participants with previous exposure to biologic anti-tumor necrosis factor (TNF) agents
- Participants with severe extensive UC that is likely to require a colectomy (surgery to remove part or all of the colon) within 12 weeks of study entry
- Participants having UC limited to the rectum only or to less than 20 centimeter (cm) of the colon
- Presence of a stoma (an artificial permanent opening especially in the abdominal wall made in surgical procedures) or presence of a fistula
- Participants with a history of extensive colonic resection
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 |
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Placebo Comparator: Placebo
Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0
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Matching placebo for golimumab, intravenous infusion administered at Week 0
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Experimental: Golimumab 1 milligram (mg) per kilogram (kg)
Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0.
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Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0
Other Names:
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Experimental: Golimumab 2 mg per kg
Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0.
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Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0
Other Names:
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Experimental: Golimumab 4 mg per kg
Golimumab 4 mg per kg, intravenous (IV) infusion administered at Week 0.
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Golimumab 4 mg per kg intravenous (IV) infusion at Week 0
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Clinical Response
Time Frame: Week 6
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Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1.
The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease.
The total Mayo score value ranges from 0 to 12.
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Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Clinical Remission
Time Frame: Week 6
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Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1.
The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease.
The total Mayo score value ranges from 0 to 12.
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Week 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
- Adedokun OJ, Xu Z, Liao S, Strauss R, Reinisch W, Feagan BG, Sandborn WJ. Population Pharmacokinetics and Exposure-Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis. Clin Ther. 2020 Jan;42(1):157-174.e4. doi: 10.1016/j.clinthera.2019.11.010. Epub 2020 Jan 22.
- Rutgeerts P, Feagan BG, Marano CW, Padgett L, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Zhang H, Colombel JF, Reinisch W, Gibson PR, Sandborn WJ; PURSUIT-IV study group. Randomised clinical trial: a placebo-controlled study of intravenous golimumab induction therapy for ulcerative colitis. Aliment Pharmacol Ther. 2015 Sep;42(5):504-14. doi: 10.1111/apt.13291. Epub 2015 Jun 29.
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
August 1, 2007
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
June 18, 2007
First Submitted That Met QC Criteria
June 18, 2007
First Posted (Estimate)
June 20, 2007
Study Record Updates
Last Update Posted (Estimate)
June 14, 2013
Last Update Submitted That Met QC Criteria
April 29, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Ulcer
- Colitis
- Colitis, Ulcerative
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tumor Necrosis Factor Inhibitors
- Antibodies, Monoclonal
- Golimumab
Other Study ID Numbers
- CR014188
- C0524T16 (Other Identifier: Janssen Research & Development, LLC)
- 2006-003397-94 (Other Identifier: Janssen Research & Development, LLC)
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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