Lead Investigator: Shenghong Zhang, The first affiliated hospital of Sun Yat-sen University
Title of Proposal Research: The prognostic value of faecal calprotectin for long-term outcomes in ulcerative colitis
Vivli Data Request: 8266
Funding Source: This work was funded by the National Natural Science Foundation of China, grant/award number: 82070538 and 81870374.
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Ulcerative colitis (UC) is a chronic inflammatory disease affecting around 2% of the general population in North America and Western Europe, and its incidence is rising worldwide. UC is an inflammatory bowel disease, which causes irritation, inflammation, and ulcers in the lining of your large intestine. Patients with UC have heterogenous prognosis: some patients have good long-term outcomes after initiation treatment, while some will suffer from relapsing and exacerbated disease courses. Therefore, predicting the prognosis of UC patients is important for selecting optimal treatment approaches and conducting personalized management. Nowadays, identifying effective indicators for predicting the prognosis in UC is receiving more and more attention. Faecal calprotectin, is a protein that your body releases in your excrement when there is inflammation in your intestines. It is an inflammatory biomarker that can be used to assess disease activity and predict relapse in UC. However, the prognostic values of faecal calprotectin and corresponding thresholds for long-term outcomes are still unknown. This study aims at investigating the predictive ability and the threshold of faecal calprotectin for long-term outcomes in UC. This analysis will include data from four clinical trials (VISIBLE, MOMENTUM, GEMINI 1 and VARSITY). Analyses will be conducted to evaluate the relationship between faecal calprotectin and the outcomes of interest, and to assess the predictive ability of faecal calprotectin by determining the level at which one might expect a UC relapse. The results will help clinicians understand the prognostic value of faecal calprotectin and may help in selecting treatment approaches for patients with different prognosis.
Requested Studies:
A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis
Data Contributor: Takeda
Study ID: NCT01124149
Sponsor ID: SPD476-409
A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
Data Contributor: Takeda
Study ID: NCT02497469
Sponsor ID: MLN0002-3026
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
Data Contributor: Takeda
Study ID: NCT02611830
Sponsor ID: MLN0002SC-3027
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis
Data Contributor: Takeda
Study ID: NCT00783718
Sponsor ID: C13006