Clinical trial NCT00488631: An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colitis, Ulcerative
Keywords: Colitis, Ulcerative
Golimumab
CNTO 148
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-06-20
Enrollment: 1228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This was a Phase 3, multicenter (conducted in more than one center), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), double-blind (neither the Physician nor the participant know about the study medication), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions), randomized-withdrawal study. Participants who were in clinical response to golimumab at Week 6 in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) will be randomly assigned in a 1:1:1 ratio at Week 0 of this study to receive 1 of the following maintenance treatment regimens administered subcutaneously every 4 weeks through Week 52: placebo, golimumab 50 mg, or golimumab 100 mg. Participants who were in clinical response to placebo and participants who were not in clinical response to golimumab or placebo at Week 6 in induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) will not be randomly assigned but will be eligible to be enrolled in the study (i.e., the nonrandomized group) and received the following treatment regimens: placebo, golimumab 100 mg and golimumab 100 mg. Dose adjustment will be done for participants who were in clinical response to golimumab or placebo during induction studies C0524T16 (NCT00488774) or C0524T17 (NCT00487539) but lose clinical response during maintenance study C0524T18 (NCT00488631). On completing this study, participant will have the opportunity to continue to receive study medication in a study extension that will last up to approximately 3 years. Efficacy will be primarily evaluated by assessing the clinical response using Mayo Score. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Number of Participants in Clinical Response Through Week 54
timeFrame: Induction Baseline, Week 0 through Week 54
Secondary outcomes:
measure: Number of Participants With Clinical Remission at Both Week 30 and Week 54
timeFrame: Week 30 and Week 54
measure: Number of Participants With Mucosal Healing at Both Week 30 and Week 54
timeFrame: Week 30 and Week 54
measure: Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study
timeFrame: Week 30 and Week 54
measure: Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study
timeFrame: Week 54
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Merced
country: United States
state: California
city: Orange
country: United States
state: California
city: Roseville
country: United States
state: California
city: San Diego
country: United States
state: California
city: Lakewood
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state: Colorado
city: Littleton
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state: Colorado
city: Bristol
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state: Connecticut
city: Newark
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state: Delaware
city: Boca Raton
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state: Florida
city: Gainesville
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state: Florida
city: Hialeah
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state: Florida
city: Hollywood
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city: Jacksonville
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city: N Miami Beach
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city: Naples
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city: New Port Richey
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state: Florida
city: Port Orange
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city: Winter Park
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city: Zephyrhills
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state: Florida
city: Atlanta
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state: Georgia
city: Decatur
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state: Georgia
city: Savannah
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state: Georgia
city: Snellville
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state: Georgia
city: Arlington Heights
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state: Illinois
city: Chicago
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city: Fort Dodge
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city: Topeka
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city: Louisville
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state: Kentucky
city: Monroe
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state: Louisiana
city: Hagerstown
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state: Maryland
city: Hollywood
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city: Malvern
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city: Parkville
country: Australia
city: Prahran
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city: Westmead
country: Australia
city: Innsbruck
country: Austria
city: Wien N/A
country: Austria
city: Bonheiden
country: Belgium
city: Brussel
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liège
country: Belgium
city: Roeselare
country: Belgium
city: Bulgaria
country: Bulgaria
city: Pleven
country: Bulgaria
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country: Bulgaria
city: Rousse
country: Bulgaria
city: Sofia
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city: Calgary
country: Canada
state: Alberta
city: Vancouver
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city: Victoria
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city: Winnipeg
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city: Barrie
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city: Chatham
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city: Hamilton
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city: Kingston
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city: London
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city: Montreal
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city: Hradec Kralove
country: Czech Republic
city: Litomerice
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Èeské Budìjovice 1
country: Czech Republic
city: Aalborg
country: Denmark
city: Aarhus C.
country: Denmark
city: Hvidovre
country: Denmark
city: Odense C
country: Denmark
city: Amiens Cedex 1 80
country: France
city: Bordeaux 33
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city: Lille Cedex
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city: Marseille Cedex 13
country: France
city: Nice Cedex 3
country: France
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country: Germany
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country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
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city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Heidelberg
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city: Jena
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city: Kiel
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city: Magdeburg
country: Germany
city: Minden
country: Germany
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city: München
country: Germany
city: Münster
country: Germany
city: Neustadt
country: Germany
city: Stade
country: Germany
city: Balatonfured
country: Hungary
city: Budapest N/A
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Dunaujvaros
country: Hungary
city: Gyulai Ut 18
country: Hungary
city: Gyula
country: Hungary
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city: Miskolc
country: Hungary
city: Mosonmagyarovar
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city: Bangalore
country: India
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city: Hyderabad Andh Prad
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city: Afula
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city: Jerusalem
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city: Kiryat Bialik
country: Israel
city: Nazareth
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country: Israel
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country: Israel
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country: Israel
city: Bunkyo-Ku
country: Japan
city: Bunkyo
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city: Chikushinoshi
country: Japan
city: Fukuoka
country: Japan
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country: Japan
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country: Japan
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country: Japan
city: Nishinomiya
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Sakura
country: Japan
city: Sapporo-Shi
country: Japan
city: Sapporo
country: Japan
city: Tokyo N/A
country: Japan
city: Tokyo
country: Japan
city: Yokkaichi
country: Japan
city: Balvi
country: Latvia
city: Daugavpils
country: Latvia
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Siauliai
country: Lithuania
city: Vilnius Lt
country: Lithuania
city: Vilnius
country: Lithuania
city: Amsterdam
country: Netherlands
city: Ede Gld
country: Netherlands
city: Groningen
country: Netherlands
city: Leiden
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Rotterdam
country: Netherlands
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Dunedin
country: New Zealand
city: Hamilton
country: New Zealand
city: Hastings
country: New Zealand
city: Bialystok N/A
country: Poland
city: Bydgoszcz N/A
country: Poland
city: Czestochowa
country: Poland
city: Elblag
country: Poland
city: Gdansk N/A
country: Poland
city: Gdansk
country: Poland
city: Krakow N/A
country: Poland
city: Krakow
country: Poland
city: Kraków N/A
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Opole N/A
country: Poland
city: Skierniewice
country: Poland
city: Sopot
country: Poland
city: Szczecin
country: Poland
city: Torun
country: Poland
city: Warszawa N/A
country: Poland
city: Warszawa
country: Poland
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Iasi
country: Romania
city: Targu Mures
country: Romania
city: Timisoara
country: Romania
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Belgrade
country: Serbia
city: Beograd
country: Serbia
city: Nis
country: Serbia
city: Zemun
country: Serbia
city: Bratislava
country: Slovakia
city: Martin
country: Slovakia
city: Nitra
country: Slovakia
city: Nove Mesto Nad Vahom
country: Slovakia
city: Presov
country: Slovakia
city: Trnava
country: Slovakia
city: Cape Town West Cape
country: South Africa
city: Cape Town
country: South Africa
city: Durban N/A
country: South Africa
city: Plumstead West Cape
country: South Africa
city: Pretoria Gauteng
country: South Africa
city: Göteborg
country: Sweden
city: Stockholm
country: Sweden
city: Donetsk
country: Ukraine
city: Ivano
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Poltava
country: Ukraine
city: Simferopol
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Zhaporozhia 69104
country: Ukraine
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.