Clinical trial NCT00488774: An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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: 291
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 effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).

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 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

Primary outcomes:
measure: Number of Participants With Clinical Response
timeFrame: Week 6
Secondary outcomes:
measure: Number of Participants With Clinical Remission
timeFrame: Week 6
Other outcomes:
Locations:
city: Orange
country: United States
state: California
city: Roseville
country: United States
state: California
city: Littleton
country: United States
state: Colorado
city: Bristol
country: United States
state: Connecticut
city: Tampa
country: United States
state: Florida
city: Fort Dodge
country: United States
state: Iowa
city: Topeka
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Laurel
country: United States
state: Maryland
city: Dearborn
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Mexico
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Great Neck
country: United States
state: New York
city: Huntington
country: United States
state: New York
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Kinston
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Columbia
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Christiansburg
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Adelaide
country: Australia
city: Brisbane
country: Australia
city: Malvern
country: Australia
city: Innsbruck N/A
country: Austria
city: Bonheiden
country: Belgium
city: Leuven
country: Belgium
city: Rousse
country: Bulgaria
city: Varna
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Clichy
country: France
city: Lille Cedex
country: France
city: Nice Cedex 3
country: France
city: Hamburg
country: Germany
state: HH
city: Berlin
country: Germany
city: Herne
country: Germany
city: Magdeburg
country: Germany
city: Budapest N/A
country: Hungary
city: Békéscsaba
country: Hungary
city: Gyulai Ut 18
country: Hungary
city: Gyõr
country: Hungary
city: Miskolc N/A
country: Hungary
city: Miskolc
country: Hungary
city: Pécs
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szombathely
country: Hungary
city: Hyderabad Andh Prad
country: India
city: Jaipur
country: India
city: Lucknow
country: India
city: Ludhiana
country: India
city: Pune
country: India
city: Afula
country: Israel
city: Hedera
country: Israel
city: Jerusalem
country: Israel
city: Kfar Sava
country: Israel
city: Tel-Aviv
country: Israel
city: Daugavpils
country: Latvia
city: Riga
country: Latvia
city: Klaipeda
country: Lithuania
city: Siauliai
country: Lithuania
city: Vilnius LT
country: Lithuania
city: Amsterdam
country: Netherlands
city: Groningen
country: Netherlands
city: Leiden
country: Netherlands
city: Rotterdam
country: Netherlands
city: Auckland
country: New Zealand
city: Hastings
country: New Zealand
city: Bialystok N/A
country: Poland
city: Czestochowa
country: Poland
city: Krakow N/A
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Skierniewice
country: Poland
city: Sopot
country: Poland
city: Bucuresti
country: Romania
city: Timisoara
country: Romania
city: Moscow
country: Russian Federation
city: St.Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Belgrade
country: Serbia
city: Beograd
country: Serbia
city: Bratislava
country: Slovakia
city: Nitra
country: Slovakia
city: Presov
country: Slovakia
city: Göteborg
country: Sweden
city: Donetsk
country: Ukraine
city: Ivano
country: Ukraine
city: Kiev
country: Ukraine
city: Vynnytsya
country: Ukraine
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
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: Rutgeerts P, Feagan BG, Marano CW, Padgett L, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Zhang H, Colombel JF, Reinisch W, Gibson PR, Sandborn WJ; PURSUIT-IV study group. Randomised clinical trial: a placebo-controlled study of intravenous golimumab induction therapy for ulcerative colitis. Aliment Pharmacol Ther. 2015 Sep;42(5):504-14. doi: 10.1111/apt.13291. Epub 2015 Jun 29.