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

NCT00488774 | Terminated Phase 2 Results DMC

• 3 other identifiers: CR014188C0524T162006-003397-94
• Study Type: interventional
• Target: 291
• Locations: 20 countries
• Sites: 106

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).

Conditions

Colitis, Ulcerative

Keywords

Colitis, ulcerative; Golimumab; CNTO 148

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Response

  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 a 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.

  Week 6

Secondary Outcomes (1)

• Number of Participants With Clinical Remission

  Week 6

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Golimumab 1 milligram (mg) per kilogram (kg)

EXPERIMENTAL

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

Drug: Golimumab 1 mg per kg

Golimumab 2 mg per kg

EXPERIMENTAL

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

Drug: Golimumab 2 mg per kg

Golimumab 4 mg per kg

EXPERIMENTAL

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

Drug: Golimumab 4 mg per kg

Interventions

Placebo OTHER

Matching placebo for golimumab, intravenous infusion administered at Week 0

Placebo

Golimumab 1 mg per kg DRUG

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

Also known as: CNTO 148

Golimumab 1 milligram (mg) per kilogram (kg)

Golimumab 2 mg per kg DRUG

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

Also known as: CNTO 148

Golimumab 2 mg per kg

Golimumab 4 mg per kg DRUG

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

Golimumab 4 mg per kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (108)

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Orange, California, United States

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Roseville, California, United States

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Littleton, Colorado, United States

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Bristol, Connecticut, United States

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Tampa, Florida, United States

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Fort Dodge, Iowa, United States

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Topeka, Kansas, United States

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Louisville, Kentucky, United States

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Laurel, Maryland, United States

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Dearborn, Michigan, United States

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Troy, Michigan, United States

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Mexico, Missouri, United States

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St Louis, Missouri, United States

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Lebanon, New Hampshire, United States

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Great Neck, New York, United States

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Huntington, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Kinston, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, 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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Austin, Texas, United States

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Galveston, Texas, United States

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Burlington, Vermont, United States

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Christiansburg, Virginia, United States

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Richmond, Virginia, United States

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Bellevue, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Adelaide, Australia

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Brisbane, Australia

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Malvern, Australia

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Innsbruck, Austria

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Bonheiden, Belgium

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Leuven, Belgium

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Rousse, Bulgaria

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Varna, Bulgaria

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Hamilton, Ontario, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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Montreal, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Clichy, France

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Lille, France

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Nice, France

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Hamburg, Hamburg, Germany

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Berlin, State of Berlin, Germany

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Herne, Germany

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Magdeburg, Germany

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Békéscsaba, Hungary

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Budapest, Hungary

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Gyõr, Hungary

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Gyulai Ut 18, Hungary

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Miskolc, Hungary

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Pécs, Hungary

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Székesfehérvár, Hungary

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Szombathely, Hungary

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Hyderabad Andh Prad, India

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Jaipur, India

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Lucknow, India

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Ludhiana, India

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Pune, India

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Afula, Israel

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Hedera, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Tel Aviv, Israel

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Daugavpils, Latvia

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Riga, Latvia

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Klaipėda, Lithuania

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Šiauliai, Lithuania

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Vilnius LT, Lithuania

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Amsterdam, Netherlands

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Groningen, Netherlands

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Leiden, Netherlands

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Rotterdam, Netherlands

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Auckland, New Zealand

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Hastings, New Zealand

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Bialystok, Poland

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Częstochowa, Poland

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Krakow, Poland

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Lodz, Poland

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Skierniewice, Poland

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Sopot, Poland

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Bucharest, Romania

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Timișoara, Romania

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Moscow, Russia

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Saint Petersburg, Russia

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Yaroslavl, Russia

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Belgrade, Serbia

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Bratislava, Slovakia

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Nitra, Slovakia

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Prešov, Slovakia

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Gothenburg, Sweden

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Donetsk, Ukraine

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Ivano, Ukraine

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Kiev, Ukraine

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Vynnytsya, Ukraine

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Related Publications (2)

• 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: 31982148 DERIVED

• 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.

  PMID: 26119226 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

golimumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Limitations and Caveats

Data collection was not considered complete for primary outcome measure because study was terminated prematurely.

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Research & Development

215-793-7540

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 20, 2007
• Study Start: August 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 14, 2013
• Results First Posted: June 14, 2013

Record last verified: 2013-04

Locations

AU (3); UA (4); BU (2); LA (2); CA (8); RO (2); SE (1); SL (3); IN (5); RU (3); IL (5); PL (6); NL (4); US (36); NZ (2); LI (3); FR (3); BE (2); DE (4); HU (8)