11 results
Primary objective: • To evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely active UC.Secondary objectives:• To evaluate the overall efficacy of tofacitinib during induction, maintenance and…
1. To compare the efficacy of tofacitinib, in doses of 2 mg, 5 mg, and 10 mg BID versus placebo on the ASAS20 response rate at Week 12 in subjects with active AS that have had an inadequate response to previous treatment.2. To estimate the placebo-…
To assess out to one-year the clinical status of patients who completed the double-blind part B of the 6-month study period in the Opsona phase II protocol (OPN305-102) by recording the following:• Incidence of biopsy-proven allograft rejection or…
The objectives of this study, in patients with moderately to severely active UC who are administered JAKi SOC therapy are to evaluate the following (ranked according to priority), both for JAKi as a class of drugs and for each individual JAKi:1.…
Primary objective:Identify pre-treatment profiles with integrated clinical, transcriptomic, metabolomic, proteomic, flow cytometric, and imaging data that predict response to treatment with tofacitinib, in DMARD-naïve and DMARD non-responsive PsA…
The primary objective of this endpoint study is to evaluate the safety of tofacitinib at two doses versus TNFi; the co-primary endpoints are adjudicated major adverse cardiovascular events (MACE) and adjudicated malignancies excluding non-melanoma…
Primary Objectives:*Phase 0: To determine the receptor occupancy of OPN-305 1.5mg/kg in patients receiving an ECD, DCD or SCD(CIT>18h) kidney transplantation and to verify the doses of OPN-305 to be used in Part A of the study.*Part A: to…
The purpose of the research trial is to assess if heart failure markers and clinical end-points are influenced by 24 hours of AV-node stimulation (AVNS) in acutely decompensated heart failure (ADHF) patients.Primary Objective(s)The primary objective…
To evaluate the efficacy of tofacitinib treatment in patients with RCDII with persistent or recurrent villous atrophy (Marsh III ABC) and aberrant IEL T-cells (> 20% as assessed by flow cytometry).
To assess efficacy and safety of tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis.
To evaluate the tofacitinib and infliximab treatment-induced changes in plasma lipids and lipoproteins and to provide insight in the underlying mechanism in relation to the inflammatory status in patients with active UC.