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

Part of paid clinical trials in La Jolla, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT01988961
Phase
PHASE2
Status
Completed

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Dec 31, 2013
Status verified
Dec 2016
Primary completion
Feb 28, 2015
Completion
Jan 31, 2016

Study Design

Enrollment
103 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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. [ Time Frame: Week 6 ]

Locations (15)

FacilityCityStateZIPSite coordinators
-La JollaCalifornia--
-National CityCalifornia--
-DenverColorado--
-GoldenColorado--
-MaitlandFlorida--
-Winter ParkFlorida--
-ZephyrhillsFlorida--
-SuwaneeGeorgia--
-Idaho FallsIdaho--
-Crestview HillsKentucky--
-RochesterMinnesota--
-Kansas CityMissouri--
-CincinnatiOhio--
-ColumbiaSouth Carolina--
-ChesapeakeVirginia--

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