An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

This study has been terminated.
(Protocol was cancelled by company based on overall efficacy, no safety concern)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00488774
First received: June 18, 2007
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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).


Condition Intervention Phase
Colitis, Ulcerative
Other: Placebo
Drug: Golimumab 1 mg per kg
Drug: Golimumab 2 mg per kg
Drug: Golimumab 4 mg per kg
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Number of Participants With Clinical Response [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Clinical Remission [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.


Enrollment: 291
Study Start Date: August 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0
Other: Placebo
Matching placebo for golimumab, intravenous infusion administered at Week 0
Experimental: Golimumab 1 milligram (mg) per kilogram (kg)
Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0.
Drug: Golimumab 1 mg per kg
Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0
Other Name: CNTO 148
Experimental: Golimumab 2 mg per kg
Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0.
Drug: Golimumab 2 mg per kg
Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0
Other Name: CNTO 148
Experimental: Golimumab 4 mg per kg
Golimumab 4 mg per kg, intravenous (IV) infusion administered at Week 0.
Drug: Golimumab 4 mg per kg
Golimumab 4 mg per kg intravenous (IV) infusion at Week 0

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488774

  Hide Study Locations
Locations
United States, California
Orange, California, United States
Roseville, California, United States
United States, Colorado
Littleton, Colorado, United States
United States, Connecticut
Bristol, Connecticut, United States
United States, Florida
Tampa, Florida, United States
United States, Iowa
Fort Dodge, Iowa, United States
United States, Kansas
Topeka, Kansas, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Maryland
Laurel, Maryland, United States
United States, Michigan
Dearborn, Michigan, United States
Troy, Michigan, United States
United States, Missouri
Mexico, Missouri, United States
St. Louis, Missouri, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New York
Great Neck, New York, United States
Huntington, New York, United States
New York, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Kinston, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Columbia, South Carolina, United States
United States, Tennessee
Germantown, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Austin, Texas, United States
Galveston, Texas, United States
United States, Vermont
Burlington, Vermont, United States
United States, Virginia
Christiansburg, Virginia, United States
Richmond, Virginia, United States
United States, Washington
Bellevue, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Australia
Adelaide, Australia
Brisbane, Australia
Malvern, Australia
Austria
Innsbruck N/A, Austria
Belgium
Bonheiden, Belgium
Leuven, Belgium
Bulgaria
Rousse, Bulgaria
Varna, Bulgaria
Canada, Alberta
Calgary, Alberta, Canada
Canada, British Columbia
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Canada, Ontario
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada
France
Clichy, France
Lille Cedex, France
Nice Cedex 3, France
Germany
Hamburg, HH, Germany
Berlin, Germany
Herne, Germany
Magdeburg, Germany
Hungary
Budapest N/A, Hungary
Békéscsaba, Hungary
Gyulai Ut 18, Hungary
Gyõr, Hungary
Miskolc, Hungary
Miskolc N/A, Hungary
Pécs, Hungary
Szekesfehervar, Hungary
Szombathely, Hungary
India
Hyderabad Andh Prad, India
Jaipur, India
Lucknow, India
Ludhiana, India
Pune, India
Israel
Afula, Israel
Hedera, Israel
Jerusalem, Israel
Kfar Sava, Israel
Tel-Aviv, Israel
Latvia
Daugavpils, Latvia
Riga, Latvia
Lithuania
Klaipeda, Lithuania
Siauliai, Lithuania
Vilnius LT, Lithuania
Netherlands
Amsterdam, Netherlands
Groningen, Netherlands
Leiden, Netherlands
Rotterdam, Netherlands
New Zealand
Auckland, New Zealand
Hastings, New Zealand
Poland
Bialystok N/A, Poland
Czestochowa, Poland
Krakow, Poland
Krakow N/A, Poland
Lodz, Poland
Skierniewice, Poland
Sopot, Poland
Romania
Bucuresti, Romania
Timisoara, Romania
Russian Federation
Moscow, Russian Federation
St.Petersburg, Russian Federation
Yaroslavl, Russian Federation
Serbia
Belgrade, Serbia
Beograd, Serbia
Slovakia
Bratislava, Slovakia
Nitra, Slovakia
Presov, Slovakia
Sweden
Göteborg, Sweden
Ukraine
Donetsk, Ukraine
Ivano, Ukraine
Kiev, Ukraine
Vynnytsya, Ukraine
Sponsors and Collaborators
Janssen Research & Development, LLC
Merck Sharp & Dohme Corp.
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00488774     History of Changes
Obsolete Identifiers: NCT01842152
Other Study ID Numbers: CR014188, C0524T16, 2006-003397-94
Study First Received: June 18, 2007
Results First Received: April 29, 2013
Last Updated: April 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Colitis, ulcerative
Golimumab
CNTO 148

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014