Prediction of Golimumab Response in the PROgECT Phase 2a Open-Label Trial of Patients With Ulcerative Colitis

PROgECT (ClinicalTrials.gov Identifier: NCT01988961) was a multicenter, open-label study evaluating the accuracy of a probe-set panel in predicting response to golimumab treatment in participants with moderately to severely active ulcerative colitis (UC). Biopsy samples (collected 15 to 20 cm from the anal verge) were taken at screening from 84 patients and used for RNA extraction and profiling by microarrays. All patients enrolled in the study received the approved induction dose regimen of subcutaneous (SC) golimumab. A gene expression profiling study was conducted in which colon biopsy samples were collected for RNA extraction and hybridization to microarrays from patients (n=84) with moderate-to-severe ulcerative colitis.