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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01988961
First received: November 14, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the accuracy 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).


Condition Intervention Phase
Colitis, Ulcerative
Biological: Golimumab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • The area under the Receiver Operating Characteristic curve of the length-109 probe set panel as a predictor of mucosal healing at Week 6. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy 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.


Secondary Outcome Measures:
  • The area under the Receiver Operating Characteristic curve of the length-109 probe set panel as a predictor of clinical response at Week 6 and at Week 30 [ Time Frame: Week 6 and Week 30 ] [ Designated as safety issue: No ]
    The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict clinical response. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting clinical response than "flipping a coin". Areas above 0.5 represent increasing accuracy.

  • The area under the Receiver Operating Characteristic curve of the length-109 probe set panel as a predictor of clinical remission at Week 6 and at Week 30 [ Time Frame: Week 6 and Week 30 ] [ Designated as safety issue: No ]
    The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict clinical remission. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting clinical remission than "flipping a coin". Areas above 0.5 represent increasing accuracy.

  • The area under the Receiver Operating Characteristic curve of the length-109 probe set panel as a predictor of mucosal healing at Week 30 [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
    The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy 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 30. 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.


Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Golimumab
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
SC injections
Other Name: SIMPONI

Detailed Description:

The study drug, golimumab, belongs to a group of medicines known as tumor necrosis factor (TNF) inhibitors and is approved in the United States, European Union, and Canada for treatment of UC. Studies have shown that people respond differently to treatment with TNF inhibitors and furthermore, some people may not actually respond to treatment. Tests which could predict the likelihood of response to golimumab prior to treatment would be of benefit to people with UC. This is an open label (physicians and participants know the identity of the assigned treatment), multicenter study to evaluate the accuracy of a genetic test (the length-109 probe set panel) in predicting response to golimumab treatment in patients with moderately to severely active UC. The study will consist of a screening phase, an open label treatment phase (Week 0 to Week 50), and a follow-up visit at Week 58. The length-109 probe set panel will be tested on samples obtained from colonic biopsies taken prior to treatment with golimumab for all participants at screening. All participants enrolled in the study will receive subcutaneous golimumab from Week 0 to Week 50; participants will be given the option to self-administer golimumab from Week 6 onwards. Blood and fecal samples will be taken at various time points during the study; colonic biopsies will be taken at screening, Week 6, and Week 30; and endoscopies will be performed at Week 0, Week 6, and Week 30. The study duration for each participant is expected to be approximately 58 weeks. Participant safety will be monitored throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988961

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
United States, California
Recruiting
La Jolla, California, United States
Recruiting
National City, California, United States
United States, Colorado
Recruiting
Denver, Colorado, United States
Recruiting
Golden, Colorado, United States
United States, Florida
Recruiting
Maitland, Florida, United States
Recruiting
Zephyrhills, Florida, United States
United States, Georgia
Recruiting
Suwanee, Georgia, United States
United States, Minnesota
Recruiting
Rochester, Minnesota, United States
United States, Missouri
Recruiting
Kansas City, Missouri, United States
United States, Virginia
Recruiting
Chesapeake, Virginia, United States
Canada, Ontario
Recruiting
Vaughan, Ontario, Canada
Canada, Quebec
Withdrawn
Montreal, Quebec, Canada
Poland
Recruiting
Wroclaw, Poland
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01988961     History of Changes
Other Study ID Numbers: CR102851, CNTO148UCO2001, 2013-002042-36
Study First Received: November 14, 2013
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: National Agency for the Safety of Medicines and Health Products
Germany:Federal Institute for Medicinal Products and Medical Devices
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Federal Service on Surveillance in Healthcare
Ukraine: State Expert Center

Keywords provided by Janssen Research & Development, LLC:
Colitis, Ulcerative
Golimumab
CNTO148
SIMPONI
Length-109 Probe Set Panel

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014