An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT00488631
Last Updated: 2016-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1228 participants
INTERVENTIONAL
2007-09-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Golimumab induction responders (GLM-I-Rsp)-Placebo Maintenance
Participants 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.
Placebo
Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
Golimumab 100 mg
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.
GLM-I-Rsp-Golimumab 50 mg Maintenance
Participants 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.
Golimumab 50 mg
Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
Golimumab 100 mg
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.
GLM-I-Rsp-Golimumab 100 mg Maintenance
Participants 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.
Golimumab 100 mg
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.
Golimumab 200 mg
Participants receiving golimumab 100 mg initially who on loss of clinical response receive golimumab 200 mg administered every 4 weeks through Week 52.
Placebo induction responders (PBO-I-Rsp)-Placebo Maintenance
Participants 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.
Placebo
Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
Golimumab 100 mg
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.
PBO-I-nonRsp-Golimumab 100 mg Maintenance
Participants 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.
Golimumab 100 mg
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.
GLM-I-nonRsp-Golimumab 100 mg Maintenance
Participants 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.
Golimumab 100 mg
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.
Interventions
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Placebo
Participants receive placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
Golimumab 50 mg
Participants receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631).
Golimumab 100 mg
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.
Golimumab 200 mg
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
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Birmingham, Alabama, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Merced, California, United States
Orange, California, United States
Roseville, California, United States
San Diego, California, United States
Lakewood, Colorado, United States
Littleton, Colorado, United States
Bristol, Connecticut, United States
Newark, Delaware, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Naples, Florida, United States
New Port Richey, Florida, United States
North Miami Beach, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Savannah, Georgia, United States
Snellville, Georgia, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Clive, Iowa, United States
Fort Dodge, Iowa, United States
Pratt, Kansas, United States
Topeka, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Monroe, Louisiana, United States
Hagerstown, Maryland, United States
Hollywood, Maryland, United States
Laurel, Maryland, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Dearborn, Michigan, United States
Troy, Michigan, United States
Plymouth, Minnesota, United States
Rochester, Minnesota, United States
Pascagoula, Mississippi, United States
Tupelo, Mississippi, United States
Urbana, Missouri, United States
Las Vegas, Nevada, United States
Lebanon, New Hampshire, United States
Egg Harbor, New Jersey, United States
Great Neck, New York, United States
Huntington, New York, United States
New York, New York, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Boone, North Carolina, United States
Charlotte, North Carolina, United States
Harrisburg, North Carolina, United States
Kinston, North Carolina, United States
Morganton, North Carolina, United States
New Bern, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Colombus, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Limerick, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Logan, Utah, United States
Ogden, Utah, United States
Burlington, Vermont, United States
Chesapeake, Virginia, United States
Christiansburg, Virginia, United States
Fairfax, Virginia, United States
Richmond, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Adelaide, , Australia
Bankstown, , Australia
Box Hill, , Australia
Brisbane, , Australia
Cairns, , Australia
Fitzroy, , Australia
Fremantle, , Australia
Herston, , Australia
Launceston, , Australia
Malvern, , Australia
Parkville, , Australia
Prahran, , Australia
Westmead, , Australia
Innsbruck, , Austria
Vienna, , Austria
Bonheiden, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Liège, , Belgium
Roeselare, , Belgium
Bulgaria, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Barrie, Ontario, Canada
Chatham, Ontario, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Vaughan, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Toronto, , Canada
Windsor, , Canada
Èeské Budìjovice 1, , Czechia
Hradec Králové, , Czechia
Litoměřice, , Czechia
Ostrava, , Czechia
Aalborg, , Denmark
Aarhus C, , Denmark
Hvidovre, , Denmark
Odense C, , Denmark
Amiens Cedex 1 80, , France
Bordeaux, , France
Clichy, , France
Lille, , France
Marseille, , France
Nice, , France
Paris, , France
Rouen, , France
Aachen, , Germany
Berlin, , Germany
Berlin Be, , Germany
Bochum, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Herne, , Germany
Jena, , Germany
Kiel, , Germany
Magdeburg, , Germany
Minden, , Germany
München, , Germany
Münster, , Germany
Neustadt, , Germany
Stade, , Germany
Balatonfüred, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Dunaújváros, , Hungary
Gyõr, , Hungary
Gyula, , Hungary
Gyulai Ut 18, , Hungary
Miskolc, , Hungary
Mosonmagyaróvár, , Hungary
Pécs, , Hungary
Siófok, , Hungary
Sopron, , Hungary
Szeged, , Hungary
Szekszárd, , Hungary
Székesfehérvár, , Hungary
Szombathely, , Hungary
Veszprém, , Hungary
Zalaegerszeg, , Hungary
Bangalore, , India
Chennai, , India
Hyderabad, , India
Hyderabad Andh Prad, , India
Jaipur, , India
Kārnād, , India
Lucknow Gpo, , India
Ludhiana, , India
New Delhi, , India
Pune, , India
Vishakapatanam, , India
Afula, , Israel
Beer Yaakov, , Israel
Beersheba, , Israel
Haifa, , Israel
Hedera, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Kiryat Bialik, , Israel
Nazareth, , Israel
Petah-Tikv, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Bunkyō City, , Japan
Chikushinoshi, , Japan
Fukuoka, , Japan
Hiroshima, , Japan
Kagoshima, , Japan
Kurashiki, , Japan
Kurume, , Japan
Nagoya, , Japan
Nishinomiya, , Japan
Okayama, , Japan
Osaka, , Japan
Sakura, , Japan
Sapporo, , Japan
Tokyo, , Japan
Yokkaichi, , Japan
Balvi, , Latvia
Daugavpils, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Klaipėda, , Lithuania
Šiauliai, , Lithuania
Vilnius, , Lithuania
Vilnius Lt, , Lithuania
Amsterdam, , Netherlands
Ede Gld, , Netherlands
Groningen, , Netherlands
Leiden, , Netherlands
Nieuwegein, , Netherlands
Rotterdam, , Netherlands
Auckland, , New Zealand
Christchurch, , New Zealand
Dunedin, , New Zealand
Hamilton, , New Zealand
Hastings, , New Zealand
Bialystok, , Poland
Bydgoszcz, , Poland
Częstochowa, , Poland
Elblag, , Poland
Gdansk, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Opole, , Poland
Skierniewice, , Poland
Sopot, , Poland
Szczecin, , Poland
Torun, , Poland
Warsaw, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Iași, , Romania
Târgu Mureş, , Romania
Timișoara, , Romania
Moscow, , Russia
Novosibirsk, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Smolensk, , Russia
Yaroslavl, , Russia
Belgrade, , Serbia
Niš, , Serbia
Zemun, , Serbia
Bratislava, , Slovakia
Martin, , Slovakia
Nitra, , Slovakia
Nové Mesto nad Váhom, , Slovakia
Prešov, , Slovakia
Trnava, , Slovakia
Cape Town, , South Africa
Cape Town West Cape, , South Africa
Durban, , South Africa
Plumstead West Cape, , South Africa
Pretoria Gauteng, , South Africa
Gothenburg, , Sweden
Stockholm, , Sweden
Donetsk, , Ukraine
Ivano, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Poltava, , Ukraine
Simferopol, , Ukraine
Vinnitsa, , Ukraine
Zhaporozhia 69104, , Ukraine
Countries
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References
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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.
Perrig 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.
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.
Philip 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.
Reinisch 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.
Sandborn 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.
Other Identifiers
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2006-003399-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C0524T18
Identifier Type: OTHER
Identifier Source: secondary_id
CR014179
Identifier Type: -
Identifier Source: org_study_id
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