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

Completed · Phase 2

Conditions studied: Colitis, Ulcerative

In brief

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).

Key facts

Study ID

NCT01988961

Run by

Janssen Research & Development, LLC

People needed

103

Starts

2013-12-01

Expected to finish

2016-01-01

Last updated by the study team

2017-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — La Jolla, California, United States
• Study site — National City, California, United States
• Study site — Denver, Colorado, United States
• Study site — Golden, Colorado, United States
• Study site — Maitland, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Zephyrhills, Florida, United States
• Study site — Suwanee, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Crestview Hills, Kentucky, United States
• Study site — Rochester, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbia, South Carolina, United States
• Study site — Chesapeake, Virginia, United States
• Study site — Ghent, Belgium
• Study site — Leuven, Belgium
• Study site — Roeselare, Belgium
• Study site — Rousse, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Victoria, British Columbia, Canada
• Study site — London, Ontario, Canada
• Study site — Vaughan, Ontario, Canada
• Study site — Hradec Králové, Czechia
• Study site — Prague, Czechia

Full record on ClinicalTrials.gov

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