An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

NCT ID: NCT00488774

Last Updated: 2013-06-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 291 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-05-31

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.

Conditions

Colitis, Ulcerative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching placebo for golimumab, intravenous infusion administered at Week 0

Golimumab 1 milligram (mg) per kilogram (kg)

Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0.

Group Type: EXPERIMENTAL

Golimumab 1 mg per kg

Intervention Type: DRUG

Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0

Golimumab 2 mg per kg

Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0.

Group Type: EXPERIMENTAL

Golimumab 2 mg per kg

Intervention Type: DRUG

Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0

Golimumab 4 mg per kg

Golimumab 4 mg per kg, intravenous (IV) infusion administered at Week 0.

Group Type: EXPERIMENTAL

Golimumab 4 mg per kg

Intervention Type: DRUG

Golimumab 4 mg per kg intravenous (IV) infusion at Week 0

Interventions

Placebo

Matching placebo for golimumab, intravenous infusion administered at Week 0

Intervention Type: OTHER

Golimumab 1 mg per kg

Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0

Intervention Type: DRUG

Golimumab 2 mg per kg

Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0

Intervention Type: DRUG

Golimumab 4 mg per kg

Golimumab 4 mg per kg intravenous (IV) infusion at Week 0

Intervention Type: DRUG

Other Intervention Names

CNTO 148; CNTO 148

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Orange, California, United States

Roseville, California, United States

Littleton, Colorado, United States

Bristol, Connecticut, United States

Tampa, Florida, United States

Fort Dodge, Iowa, United States

Topeka, Kansas, United States

Louisville, Kentucky, United States

Laurel, Maryland, United States

Dearborn, Michigan, United States

Troy, Michigan, United States

Mexico, Missouri, United States

St Louis, Missouri, United States

Lebanon, New Hampshire, United States

Great Neck, New York, United States

Huntington, New York, United States

New York, New York, United States

Charlotte, North Carolina, United States

Kinston, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, 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

Galveston, Texas, United States

Burlington, Vermont, United States

Christiansburg, Virginia, United States

Richmond, Virginia, United States

Bellevue, Washington, United States

Madison, Wisconsin, United States

Milwaukee, Wisconsin, United States

Adelaide, , Australia

Brisbane, , Australia

Malvern, , Australia

Innsbruck, , Austria

Bonheiden, , Belgium

Leuven, , Belgium

Rousse, , Bulgaria

Varna, , Bulgaria

Calgary, Alberta, Canada

Vancouver, British Columbia, Canada

Victoria, British Columbia, Canada

Hamilton, Ontario, Canada

Kingston, Ontario, Canada

London, Ontario, Canada

Montreal, Quebec, Canada

Saskatoon, Saskatchewan, Canada

Clichy, , France

Lille, , France

Nice, , France

Hamburg, City state of Hamburg, Germany

Berlin, State of Berlin, Germany

Herne, , Germany

Magdeburg, , Germany

Békéscsaba, , Hungary

Budapest, , Hungary

Gyõr, , Hungary

Gyulai Ut 18, , Hungary

Miskolc, , Hungary

Pécs, , Hungary

Székesfehérvár, , Hungary

Szombathely, , Hungary

Hyderabad Andh Prad, , India

Jaipur, , India

Lucknow, , India

Ludhiana, , India

Pune, , India

Afula, , Israel

Hedera, , Israel

Jerusalem, , Israel

Kfar Saba, , Israel

Tel Aviv, , Israel

Daugavpils, , Latvia

Riga, , Latvia

Klaipėda, , Lithuania

Šiauliai, , Lithuania

Vilnius LT, , Lithuania

Amsterdam, , Netherlands

Groningen, , Netherlands

Leiden, , Netherlands

Rotterdam, , Netherlands

Auckland, , New Zealand

Hastings, , New Zealand

Bialystok, , Poland

Częstochowa, , Poland

Krakow, , Poland

Lodz, , Poland

Skierniewice, , Poland

Sopot, , Poland

Bucharest, , Romania

Timișoara, , Romania

Moscow, , Russia

Saint Petersburg, , Russia

Yaroslavl, , Russia

Belgrade, , Serbia

Bratislava, , Slovakia

Nitra, , Slovakia

Prešov, , Slovakia

Gothenburg, , Sweden

Donetsk, , Ukraine

Ivano, , Ukraine

Kiev, , Ukraine

Vynnytsya, , Ukraine

Countries

United States; Australia; Austria; Belgium; Bulgaria; Canada; France; Germany; Hungary; India; Israel; Latvia; Lithuania; Netherlands; New Zealand; Poland; Romania; Russia; Serbia; Slovakia; Sweden; Ukraine

References

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.

Reference Type: DERIVED

PMID: 31982148 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26119226 (View on PubMed)

Other Identifiers

C0524T16

Identifier Type: OTHER

Identifier Source: secondary_id

2006-003397-94

Identifier Type: OTHER

Identifier Source: secondary_id

CR014188

Identifier Type: -

Identifier Source: org_study_id

NCT01842152

Identifier Type: -

Identifier Source: nct_alias