A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

NCT01988961 | Completed Phase 2

• 3 other identifiers: CR102851CNTO148UCO20012013-002042-36
• Study Type: interventional
• Target: 103
• Locations: 12 countries
• Sites: 45

Brief Summary

The purpose of this study is to evaluate the accuracy of a subset of the length-109 probe set panel (a genetic test) in predicting response to golimumab treatment in participants with moderately to severely active ulcerative colitis (UC).

Conditions

Colitis, Ulcerative

Keywords

Colitis, Ulcerative; Golimumab; CNTO148; SIMPONI; Length-109 Probe Set Panel

Outcome Measures

Primary Outcomes (1)

• The area under the Receiver Operating Characteristic curve of a subset of the length-109 probe set panel as a predictor of mucosal healing at Week 6.

  The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of a subset of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict mucosal healing at Week 6. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting mucosal healing than "flipping a coin". Areas above 0.5 represent increasing accuracy.

  Week 6

Secondary Outcomes (3)

• The area under the Receiver Operating Characteristic curve of a subset of the length-109 probe set panel as a predictor of clinical response at Week 6 and at Week 30

  Week 6 and Week 30

• The area under the Receiver Operating Characteristic curve of a subset of the length-109 probe set panel as a predictor of clinical remission at Week 6 and at Week 30

  Week 6 and Week 30

• The area under the Receiver Operating Characteristic curve of a subset of the length-109 probe set panel as a predictor of mucosal healing at Week 30

  Week 30

Study Arms (1)

Golimumab

EXPERIMENTAL

Participants will receive the approved induction subcutaneous (SC) dose regimen of 200 mg at Week 0 followed by 100 mg at Week 2. At Week 6 and thereafter through Week 50, participants will receive the SC maintenance dosage of golimumab that has been approved for UC in the country in which the study is being conducted. In countries where golimumab is not approved for UC, a maintenance dosage of 100 mg every 4 weeks will be used.

Biological: Golimumab

Interventions

Golimumab BIOLOGICAL

SC injections

Also known as: SIMPONI

Golimumab

Eligibility Criteria

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

You may qualify if:

• Must have the following: a clinical diagnosis of moderately to severely active ulcerative colitis (UC), defined as a baseline Mayo score of 6 to 12 (inclusive), for at least 3 months prior to screening; and a screening endoscopy with a \> = 2 endoscopy sub score of the Mayo score as determined by a central reading of the video endoscopy
• Prior or current medication for UC must be as per protocol
• Prior to the screening endoscopy or the earliest entry in the Mayo diary card (whichever of these 2 events comes first) the following conditions must be met: per protocol requirements for treatment with 6-mercaptopurine, azathioprine, or methotrexate; per protocol requirements for treatment with oral 5-aminosalicylate or oral corticosteroids; treatment must have been discontinued for at least 2 weeks for rectal corticosteroids, rectal 5-aminosalicylate compounds, parenteral corticosteroids, total parenteral nutrition, pentoxifylline, thalidomide or related agents, and antibiotics for the treatment of UC; and treatment with 6-thioguanine must have been discontinued for at least 4 weeks
• Must have had a colonoscopy as per the time frame described in the protocol for the following: extensive colitis for \> = 8 years; disease limited to the left side of the colon for \> = 10 years; participants \> = 45 years of age to assess for the presence of adenomatous polyps
• Must meet the tuberculosis and hepatitis B virus screening criteria as defined in the protocol

You may not qualify if:

• The presence of any of the following: severe extensive colitis; UC limited to the rectum only or to \<20 cm of the colon; a stoma; a fistula (or history of a fistula); symptomatic colonic or small bowel obstruction; adenomatous colonic polyps (or history of adenomatous colonic polyps); or indeterminate colitis or clinical findings suggestive of Crohn's disease
• History of extensive colonic resection (eg, less than 30 cm of colon remaining) or colonic mucosal dysplasia; requires (or has required within the 2 months prior to screening) surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, intra abdominal or pancreatic abscess requiring surgical drainage
• Have received the following concomitant or previous medical therapies: biologic therapy targeted at tumor necrosis factor alpha (eg, infliximab, adalimumab, golimumab, etanercept, certolizumab); natalizumab within 12 months of first golimumab administration; agents that deplete B- or T-cells (eg, rituximab, alemtuzumab, or visilizumab) within 12 months of first golimumab administration, or continue to manifest depletion of B- or T-cells more than 12 months after completion of therapy with lymphocyte depleting agents; cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 8 weeks prior to first administration of golimumab; vedolizumab within 8 weeks prior to first golimumab administration; apheresis (ie, Adacolumn apheresis) within 2 weeks prior to first administration of golimumab; any investigational drug within 4 weeks prior to first administration of golimumab or within 5 half-lives of the investigational agent, whichever is longer; or oral corticosteroids at a dose of greater than 40 mg of prednisone or its equivalent per day
• Have received, or are expected to receive, any live viral or bacterial vaccination within 8 weeks (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of golimumab or have had Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening
• History of, or currently active illness, considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the participant from the study or that could interfere with the interpretation of the study results

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (45)

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La Jolla, California, United States

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National City, California, United States

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Denver, Colorado, United States

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Golden, Colorado, United States

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Maitland, Florida, United States

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Winter Park, Florida, United States

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Zephyrhills, Florida, United States

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Suwanee, Georgia, United States

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Idaho Falls, Idaho, United States

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Crestview Hills, Kentucky, United States

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Rochester, Minnesota, United States

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Kansas City, Missouri, United States

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Cincinnati, Ohio, United States

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Columbia, South Carolina, United States

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Chesapeake, Virginia, United States

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Ghent, Belgium

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Leuven, Belgium

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Roeselare, Belgium

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Rousse, Bulgaria

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Sofia, Bulgaria

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Victoria, British Columbia, Canada

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London, Ontario, Canada

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Vaughan, Ontario, Canada

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Hradec Králové, Czechia

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Prague, Czechia

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Grenoble, France

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Lille, France

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Paris, France

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Hanover, Germany

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Kiel, Germany

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Budapest, Hungary

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Gyula, Hungary

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Mosonmagyaróvár, Hungary

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Amsterdam, Netherlands

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Sittard-Geleen, Netherlands

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Elblag, Poland

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Lodz, Poland

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Staszów, Poland

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Wroclaw, Poland

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Moscow, Russia

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Nizhny Novgorod, Russia

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Saint Petersburg, Russia

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Kharkiv, Ukraine

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Kyiv, Ukraine

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Vinnitsya, Ukraine

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Related Publications (2)

• Li K, Strauss R, Marano C, Greenbaum LE, Friedman JR, Peyrin-Biroulet L, Brodmerkel C, De Hertogh G. A Simplified Definition of Histologic Improvement in Ulcerative Colitis and its Association With Disease Outcomes up to 30 Weeks from Initiation of Therapy: Post Hoc Analysis of Three Clinical Trials. J Crohns Colitis. 2019 Aug 14;13(8):1025-1035. doi: 10.1093/ecco-jcc/jjz022.

  PMID: 30721964 DERIVED

• Telesco SE, Brodmerkel C, Zhang H, Kim LL, Johanns J, Mazumder A, Li K, Baribaud F, Curran M, Strauss R, Paxson B, Plevy S, Davison T, Knight L, Dibben S, Schreiber S, Sandborn W, Rutgeerts P, Siegel CA, Reinisch W, Greenbaum LE. Gene Expression Signature for Prediction of Golimumab Response in a Phase 2a Open-Label Trial of Patients With Ulcerative Colitis. Gastroenterology. 2018 Oct;155(4):1008-1011.e8. doi: 10.1053/j.gastro.2018.06.077. Epub 2018 Jul 4.

  PMID: 29981298 DERIVED

Related Links

• A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

golimumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: December 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 5, 2017

Record last verified: 2016-12

Locations

CZ (2); UA (3); RU (3); DE (2); PL (4); BU (2); FR (3); HU (3); CA (3); US (15); BE (3); NL (2)