An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
3 other identifiers
interventional
1,228
24 countries
292
Brief Summary
The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2007
Longer than P75 for phase_3
292 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2007
CompletedFirst Posted
Study publicly available on registry
June 20, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedResults Posted
Study results publicly available
November 11, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedApril 26, 2016
March 1, 2016
4.1 years
June 18, 2007
May 1, 2013
March 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants in Clinical Response Through Week 54
Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (\>=) 30 percent and \>= 3, with either decrease from induction baseline in rectal bleeding subscore of \>= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.
Induction Baseline, Week 0 through Week 54
Secondary Outcomes (4)
Number of Participants With Clinical Remission at Both Week 30 and Week 54
Week 30 and Week 54
Number of Participants With Mucosal Healing at Both Week 30 and Week 54
Week 30 and Week 54
Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study
Week 30 and Week 54
Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study
Week 54
Study Arms (6)
Golimumab induction responders (GLM-I-Rsp)-Placebo Maintenance
PLACEBO COMPARATORParticipants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
GLM-I-Rsp-Golimumab 50 mg Maintenance
EXPERIMENTALParticipants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks through Week 52.
GLM-I-Rsp-Golimumab 100 mg Maintenance
EXPERIMENTALParticipants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response will be re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injections every 4 weeks through Week 52.
Placebo induction responders (PBO-I-Rsp)-Placebo Maintenance
PLACEBO COMPARATORParticipants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
PBO-I-nonRsp-Golimumab 100 mg Maintenance
EXPERIMENTALParticipants not in clinical response to placebo at Week 6 induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
GLM-I-nonRsp-Golimumab 100 mg Maintenance
EXPERIMENTALParticipants not in clinical response to golimumab at Week 6 of induction study and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
Interventions
Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
Participants receive golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631) initially or after dose adjustment following loss of clinical response.
Participants receiving golimumab 100 mg initially who on loss of clinical response receive golimumab 200 mg administered every 4 weeks through Week 52.
Eligibility Criteria
You may qualify if:
- Participants who received all study agent administrations and completed the Week 6 Mayo score evaluation in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
- Participants who completed the Week 0 visit for this maintenance study C0524T18 (NCT00488631) on the same day as the Week 6 visit of the induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
You may not qualify if:
- Participants who increased the dose of their concomitant (given at the same time) UC medications since Week 0 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
- Participants who initiated a concomitant UC medication since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
- Participants who had a partial or total colectomy (surgery to remove part or all of the colon) or an ostomy (surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent) since Week 0 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539)
- Participants with signs or symptoms of latent or active granulomatous infection (including TB); a nontuberculous mycobacterial infection or opportunistic infection; or infection with HIV (Human Immunodeficiency Virus), hepatitis B, or hepatitis C
- Participants with signs and symptoms of any malignancy or suggestive of a possible lymphoproliferative disease (disorders characterized by proliferation of lymphoid tissue, general or unspecified)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (297)
Unknown Facility
Birmingham, Alabama, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Merced, California, United States
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Orange, California, United States
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Roseville, California, United States
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San Diego, California, United States
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Lakewood, Colorado, United States
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Littleton, Colorado, United States
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Bristol, Connecticut, United States
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Newark, Delaware, United States
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Boca Raton, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Naples, Florida, United States
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New Port Richey, Florida, United States
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North Miami Beach, Florida, United States
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Port Orange, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Savannah, Georgia, United States
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Snellville, Georgia, United States
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Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
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Clive, Iowa, United States
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Fort Dodge, Iowa, United States
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Pratt, Kansas, 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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Monroe, Louisiana, United States
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Hagerstown, Maryland, United States
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Hollywood, Maryland, United States
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Laurel, Maryland, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Dearborn, Michigan, United States
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Troy, Michigan, United States
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Plymouth, Minnesota, United States
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Rochester, Minnesota, United States
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Pascagoula, Mississippi, United States
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Tupelo, Mississippi, United States
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Urbana, Missouri, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Egg Harbor, New Jersey, United States
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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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Rochester, New York, United States
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Asheville, North Carolina, United States
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Boone, North Carolina, United States
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Charlotte, North Carolina, United States
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Harrisburg, North Carolina, United States
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Kinston, North Carolina, United States
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Morganton, North Carolina, United States
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New Bern, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Colombus, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Limerick, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Germantown, 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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Galveston, Texas, United States
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Houston, Texas, United States
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Logan, Utah, United States
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Ogden, Utah, United States
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Burlington, Vermont, United States
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Chesapeake, Virginia, United States
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Christiansburg, Virginia, United States
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Fairfax, Virginia, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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Seattle, Washington, United States
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Spokane, 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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Adelaide, Australia
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Bankstown, Australia
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Box Hill, Australia
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Brisbane, Australia
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Cairns, Australia
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Fitzroy, Australia
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Fremantle, Australia
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Herston, Australia
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Launceston, Australia
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Malvern, Australia
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Parkville, Australia
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Prahran, Australia
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Westmead, Australia
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Innsbruck, Austria
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Vienna, Austria
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Bonheiden, Belgium
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Bulgaria, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Barrie, Ontario, Canada
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Chatham, Ontario, Canada
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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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Vaughan, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Toronto, Canada
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Windsor, Canada
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Èeské Budìjovice 1, Czechia
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Hradec Králové, Czechia
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Litoměřice, Czechia
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Ostrava, Czechia
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Aalborg, Denmark
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Aarhus C, Denmark
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Hvidovre, Denmark
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Odense C, Denmark
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Amiens Cedex 1 80, France
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Bordeaux, France
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Clichy, France
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Lille, France
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Marseille, France
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Nice, France
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Paris, France
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Rouen, France
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Aachen, Germany
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Berlin, Germany
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Berlin Be, Germany
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Bochum, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Hanover, Germany
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Heidelberg, Germany
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Herne, Germany
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Jena, Germany
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Kiel, Germany
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Magdeburg, Germany
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Minden, Germany
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München, Germany
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Münster, Germany
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Neustadt, Germany
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Stade, Germany
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Balatonfüred, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Dunaújváros, Hungary
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Gyõr, Hungary
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Gyula, Hungary
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Gyulai Ut 18, Hungary
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Miskolc, Hungary
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Mosonmagyaróvár, Hungary
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Pécs, Hungary
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Siófok, Hungary
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Sopron, Hungary
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Szeged, Hungary
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Szekszárd, Hungary
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Székesfehérvár, Hungary
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Szombathely, Hungary
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Veszprém, Hungary
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Zalaegerszeg, Hungary
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Bangalore, India
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Chennai, India
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Hyderabad, India
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Hyderabad Andh Prad, India
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Jaipur, India
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Kārnād, India
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Lucknow Gpo, India
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Ludhiana, India
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New Delhi, India
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Pune, India
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Vishakapatanam, India
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Afula, Israel
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Beer Yaakov, Israel
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Beersheba, Israel
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Haifa, Israel
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Hedera, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Kiryat Bialik, Israel
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Nazareth, Israel
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Petah-Tikv, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Bunkyō City, Japan
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Chikushinoshi, Japan
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Fukuoka, Japan
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Hiroshima, Japan
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Kagoshima, Japan
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Kurashiki, Japan
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Kurume, Japan
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Nagoya, Japan
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Nishinomiya, Japan
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Okayama, Japan
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Osaka, Japan
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Sakura, Japan
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Sapporo, Japan
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Tokyo, Japan
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Yokkaichi, Japan
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Balvi, Latvia
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Daugavpils, Latvia
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Riga, Latvia
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Šiauliai, Lithuania
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Vilnius, Lithuania
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Vilnius Lt, Lithuania
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Amsterdam, Netherlands
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Ede Gld, Netherlands
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Groningen, Netherlands
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Leiden, Netherlands
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Nieuwegein, Netherlands
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Rotterdam, Netherlands
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Auckland, New Zealand
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Christchurch, New Zealand
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Dunedin, New Zealand
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Hamilton, New Zealand
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Hastings, New Zealand
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Bialystok, Poland
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Bydgoszcz, Poland
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Częstochowa, Poland
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Elblag, Poland
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Gdansk, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Opole, Poland
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Skierniewice, Poland
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Sopot, Poland
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Szczecin, Poland
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Torun, Poland
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Warsaw, Poland
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Bucharest, Romania
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Cluj-Napoca, Romania
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Iași, Romania
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Târgu Mureş, Romania
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Timișoara, Romania
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Moscow, Russia
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Novosibirsk, Russia
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Omsk, Russia
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Saint Petersburg, Russia
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Smolensk, Russia
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Yaroslavl, Russia
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Belgrade, Serbia
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Niš, Serbia
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Zemun, Serbia
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Bratislava, Slovakia
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Martin, Slovakia
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Nitra, Slovakia
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Nové Mesto nad Váhom, Slovakia
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Prešov, Slovakia
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Trnava, Slovakia
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Cape Town, South Africa
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Cape Town West Cape, South Africa
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Durban, South Africa
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Plumstead West Cape, South Africa
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Pretoria Gauteng, South Africa
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Gothenburg, Sweden
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Stockholm, Sweden
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Donetsk, Ukraine
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Ivano, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Kyiv, Ukraine
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Lviv, Ukraine
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Poltava, Ukraine
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Simferopol, Ukraine
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Vinnitsa, Ukraine
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Zhaporozhia 69104, Ukraine
Related Publications (6)
Weinstein CLJ, Meehan AG, Govoni M, Lin J, Reinisch W. Low Occurrence of Colectomy With Long-Term (up to 4 Years) Golimumab Treatment in Patients With Moderate-to-Severe Active Ulcerative Colitis: Data From the PURSUIT Maintenance and Long-Term Extension Studies. Crohns Colitis 360. 2023 Aug 26;5(3):otad044. doi: 10.1093/crocol/otad044. eCollection 2023 Jul.
PMID: 37691729DERIVEDPerrig K, Krupka N, Jordi SBU, Rossel JB, Biedermann L, Greuter T, Schreiner P, Vavricka SR, Juillerat P, Burri E, Zimmermann D, Maillard MH, Sulz MC, Brand S, Rogler G, Misselwitz B. Effectiveness of golimumab in patients with ulcerative colitis: results of a real-life study in Switzerland. Therap Adv Gastroenterol. 2022 Feb 9;15:17562848221074188. doi: 10.1177/17562848221074188. eCollection 2022.
PMID: 35154389DERIVEDAdedokun 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.
PMID: 31982148DERIVEDPhilip G, Cornillie F, Adedokun JO, Melsheimer R, Rutgeerts P, Colombel JF, Marano C. Early Dose Optimisation of Golimumab in Nonresponders to Induction Treatment for Ulcerative Colitis Is Effective and Supported by Pharmacokinetic Data. J Crohns Colitis. 2019 Sep 27;13(10):1257-1264. doi: 10.1093/ecco-jcc/jjz052.
PMID: 30847474DERIVEDReinisch W, Gibson PR, Sandborn WJ, Feagan BG, Strauss R, Johanns J, Padgett L, Adedokun OJ, Colombel JF, Collins J, Rutgeerts P, Tarabar D, Marano C. Long-Term Benefit of Golimumab for Patients with Moderately to Severely Active Ulcerative Colitis: Results from the PURSUIT-Maintenance Extension. J Crohns Colitis. 2018 Aug 29;12(9):1053-1066. doi: 10.1093/ecco-jcc/jjy079.
PMID: 29917070DERIVEDSandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Jarnerot G, Rutgeerts P; PURSUIT-Maintenance Study Group. Subcutaneous golimumab maintains clinical response in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):96-109.e1. doi: 10.1053/j.gastro.2013.06.010. Epub 2013 Jun 14.
PMID: 23770005DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director
- Organization
- Janssen Research & Development
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2007
First Posted
June 20, 2007
Study Start
September 1, 2007
Primary Completion
October 1, 2011
Study Completion
February 1, 2015
Last Updated
April 26, 2016
Results First Posted
November 11, 2013
Record last verified: 2016-03