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

Phase 1

Conditions: Moderately to Severely Active Ulcerative Colitis
MedDRA version: 18.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2013-002042-36-FR

Lead Sponsor: Janssen Biologics B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 103

Inclusion Criteria

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the accuracy of the length-109 probe set panel in predicting mucosal healing (ie, improvement in the endoscopic appearance of the mucosa) at Week 6 as measured by AUCROC.;Secondary Objective: 1. To evaluate the accuracy of the length-109 probe set panel in predicting clinical response at Week 6 and at Week 30 as measured by the AUCROC.<br><br>2. To evaluate the accuracy of the length-109 probe set panel in predicting clinical remission at Week 6 and at Week 30 as measured by the AUCROC.<br><br>3. To evaluate the accuracy of the length-109 probe set panel in predicting mucosal healing at Week 30 as measured by the AUCROC.<br><br>Overall safety will be assessed.<br>;Primary end point(s): AUCROC of the length-109 probe set panel in predicting mucosal healing;Timepoint(s) of evaluation of this end point: Week 6

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - The AUCROC of the length-109 probe set panel in predicting clinical response at Week 6 and at Week 30<br>- The AUCROC of the length-109 probe set panel in predicting clinical remission at Week 6 and at Week 30<br>- The AUCROC of the length-109 probe set panel in predicting mucosal healing at Week 30;Timepoint(s) of evaluation of this end point: See E.5.2

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