19 results
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…
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-…
Primary Objective* To demonstrate the efficacy of tofacitinib in inducing remission in subjects with moderately to severely active UC.Secondary Objectives* To evaluate the safety and tolerability of tofacitinib in subjects with moderately to…
The primary objective of the study is to confirm the efficacy of aliskiren 75 mg, 150 mg and 300 mg in patients with essential hypertension by testing the hypothesis of superior reduction in mean sitting systolic blood pressure (msSBP) from baseline…
The primary objective of the study is to assess the safety and tolerability of long-term open-label CP-690,550 therapy in subjects with CD.Secondary objectives are to evaluate the effect of CP-690,550 maintenance therapy on clinical remission and on…
Primary:* To determine the effect of vedolizumab IV compared to adalimumab SC on clinical remission at Week 52.Secondary:* To evaluate the effect of vedolizumab IV compared to adalimumab SC on mucosal healing at Week 52.* To evaluate the effect of…
Primary:* To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active UC who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0…
Primary Objective:To evaluate vedolizumab PK in pediatric subjects with UC or CD.Secondary Objectives:* To assess the efficacy of vedolizumab IV in pediatric subjects with UC or CD.* To characterize the dose-response relationship of vedolizumab IV…
Primary Objective: • To determine the safety profile of long-term vedolizumab IV treatment in pediatric subjects with UC or CD.Secondary Objectives:• To determine the effect of long-term vedolizumab IV treatment on time to major inflammatory bowel…
The primary objective of this trial is to determine whether, in subjects with moderately to severely active UC, treating to achieve a target of corticosteroid-free symptomatic + endoscopic + histological remission is superior to a treatment target…
This is an exploratory study to assess changes in colonic inflammation after 8 weeks of treatment with tofacitinib (XELJANZ) 2 x 5 mg BID in patients with moderate to severely active UC.
Primary Objective:To compare the efficacy of vedolizumab IV and placebo in terms of the percentage of subjects with chronic or recurrent pouchitis achieving clinically relevant remission.Secondary Objectives:To assess the efficacy of vedolizumab IV…
The primary objective of this prospective open label study is to assess the ability of vedolizumab to promote clinical, endoscopic and histological remission in patients with active UC in an 'early' and a 'late' disease…
Primary Objectives:To evaluate the proportion of subjects with fistula healing at Week 30 with 2 different dose regimens of vedolizumab IV 300 mg in subjects with perianal fistulizing CD.Secondary Objective:To evaluate fistula healing over a 30-week…
The primary objective of this trial is to determine whether, in subjects with moderately to severely active UC, treating to achieve a target of corticosteroid-free symptomatic + endoscopic + histological remission is superior to a treatment target…
Primary ObjectiveThe primary objective of this prospective open label study is to assess the ability of vedolizumab to promote clinical, endoscopic and histological remission in patients with active Crohn's disease in an 'early' and a…
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).
Our explorative pilot study wants to observe whether TDM can attribute to an efficient dose de-escalation strategy of SC vedolizumab in patients with IBD in order to reduce costs. In this study we will compare costs and clinical efficiency of TDM-…
The primary objective of this prospective placebo-controlled study is to assess the ability of vedolizumab to prevent postoperative endoscopic recurrence of Crohn*s disease in the neoterminal ileum.