An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
4 other identifiers
interventional
1,065
23 countries
189
Brief Summary
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2007
Typical duration for phase_2
189 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 14, 2007
CompletedFirst Posted
Study publicly available on registry
June 18, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
February 17, 2014
CompletedFebruary 17, 2014
January 1, 2014
3.2 years
June 14, 2007
April 29, 2013
January 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Clinical Response at Week 6
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 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.
Baseline, Week 6
Secondary Outcomes (3)
Number of Participants With Clinical Remission at Week 6
Week 6
Number of Participants With Mucosal Healing at Week 6
Week 6
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6
Baseline to Week 6
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.
Golimumab 100 mg -> 50 mg
EXPERIMENTALGolimumab 100 milligram (mg) subcutaneous injection administered at Week 0 and dose is decreased to 50 mg at Week 2.
Golimumab 200 mg -> 100 mg
EXPERIMENTALGolimumab 200 mg subcutaneous injection administered at Week 0 and dose is decreased to 100 mg at Week 2.
Golimumab 400 mg -> 200 mg
EXPERIMENTALGolimumab 400 mg subcutaneous injection administered at Week 0 and dose is decreased to 200 mg at Week 2.
Interventions
Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2.
Golimumab 100 mg subcutaneous injection administered at Week 0 for Golimumab 100 mg -\> 50 mg arm group and at Week 2 for Golimumab 200 mg -\> 100 mg arm group.
Golimumab 200 mg subcutaneous injection administered at Week 0 for Golimumab 200 mg -\> 100 mg arm group and at Week 2 for Golimumab 400 mg -\> 200 mg arm group.
Golimumab 400 mg subcutaneous injection administered at Week 0 for Golimumab 400 mg -\> 200 mg arm group.
Golimumab 50 mg subcutaneous injection administered at Week 2 for Golimumab 100 mg -\> 50 mg arm group.
Eligibility Criteria
You may qualify if:
- 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, oral corticosteroids, 6-mercaptopurine and azathioprine
- 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 tuberculosis
- Participants with negative stool test for enteric (by way of the intestines) pathogens
You may not qualify if:
- Participants with prior 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (200)
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Birmingham, Alabama, United States
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Little Rock, Arkansas, United States
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Roseville, California, United States
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San Diego, California, United States
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Golden, Colorado, 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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Naples, Florida, United States
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New Port Richey, Florida, United States
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Port Orange, 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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Savannah, 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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Pratt, Kansas, United States
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Lexington, Kentucky, United States
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Monroe, Louisiana, United States
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Ann Arbor, Michigan, United States
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Troy, Michigan, 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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Egg Harbor, New Jersey, 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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Charlotte, 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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Portland, Oregon, United States
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Limerick, Pennsylvania, 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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Houston, Texas, United States
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Sugar Land, Texas, United States
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Logan, Utah, United States
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Ogden, Utah, United States
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Chesapeake, Virginia, United States
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Fairfax, Virginia, United States
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Richmond, Virginia, 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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Bankstown, Australia
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Box Hill, Australia
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Fitzroy, Australia
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Herston, Australia
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Launceston, Australia
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Parkville, Australia
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Prahran, Australia
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Westmead, Australia
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Vienna, Austria
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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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Pleven, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Vancouver, British Columbia, Canada
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Barrie, Ontario, Canada
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Chatham, Ontario, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Saskatoon, Saskatchewan, Canada
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T2n, 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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Lille, France
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Nice, France
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Paris, France
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Berlin, Germany
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Berlin Be, Germany
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Bochum, Germany
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Hamburg, Germany
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Hanover, Germany
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Haßloch, Germany
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Kiel, Germany
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Minden, Germany
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München, Germany
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Münster, 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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Gyulai Ut 18, Hungary
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Mosonmagyaróvár, 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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Veszprém, 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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Kārnād, India
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New Delhi, India
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Pune, India
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Vishakapatanam, India
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Beer Yaakov, Israel
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Beersheba, Israel
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Haifa, Israel
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Jerusalem, Israel
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Kfar Saba, 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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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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Kaunas, Lithuania
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Vilnius, 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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Christchurch, New Zealand
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Dunedin, New Zealand
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Hamilton, New Zealand
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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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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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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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Cape Town, South Africa
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Cape Town West Cape, South Africa
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Marianhill Kz-Natal, South Africa
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Pretoria Gauteng, South Africa
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Stockholm, Sweden
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kyiv, Ukraine
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Simferopol, Ukraine
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Vynnytsya, Ukraine
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Zhaporozhia 69104, Ukraine
Related Publications (3)
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.
PMID: 31982148DERIVEDLi K, Strauss R, Marano C, Greenbaum LE, Friedman JR, Peyrin-Biroulet L, Brodmerkel C, De Hertogh G. A Simplified Definition of Histologic Improvement in Ulcerative Colitis and its Association With Disease Outcomes up to 30 Weeks from Initiation of Therapy: Post Hoc Analysis of Three Clinical Trials. J Crohns Colitis. 2019 Aug 14;13(8):1025-1035. doi: 10.1093/ecco-jcc/jjz022.
PMID: 30721964DERIVEDSandborn 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, Hibi T, Rutgeerts P; PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):85-95; quiz e14-5. doi: 10.1053/j.gastro.2013.05.048. Epub 2013 Jun 2.
PMID: 23735746DERIVED
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 2
- 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 14, 2007
First Posted
June 18, 2007
Study Start
August 1, 2007
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
February 17, 2014
Results First Posted
February 17, 2014
Record last verified: 2014-01