8 results
The purpose of this study is to evaluate the safety and effectiveness of adalimumab for the treatment of moderate to severe Crohn*s disease in children between 6-17 years of age. In addition, information will be collected to select the most…
To assess the bile acid composition of cystic bile and serum pharmacokinetics after a 3-week treatment with UDCA and to correlate pharmacokinetic parameter sof UDCA in bile and serum during steady state.To compare the composition of bile acids and…
Primary objectives (Dose-escalation Phase):• To evaluate the safety and tolerability, describe the dose-limiting toxicities (DLTs), to determine the maximum tolerated dose (MTD), optimal biological dose (OBD), or highest protocol-defined dose (HPDD…
Period 1: The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD versus placebo and versus adalimumab for the treatment of signs and symptoms of rheumatoid arthritis in subjects with moderately to severely active RA who are…
The primary objective is to investigate the association between residual disease activity at Baseline as detected by magnetic resonance imaging (MRI) and the occurrence of flares in RA subjects randomized to an adalimumab dose tapering regimen…
Primary Objective:1. To evaluate the efficacy of sonelokimab at 2 different dose levels (120 mg, 240 mg) compared with placebo in the treatment of participants withactive moderate to severe hidradenitis suppurativa.Secondary Objectives:1. To…
The primary objective of this study is:* To evaluate the effect of filgotinib compared to placebo in active psoriatic arthritis (PsA) as assessed by the American College of Rheumatology 20% improvement (ACR20) response at Week 12Secondary objectives…
This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of upadacitinib low dose once daily (QD) and high dose B QD versus placebo and versus adalimumab every other week (…