19 results
Primary Objective:To determine the efficacy of ponatinib in patients with CML in CP, AP or BP or with Ph+ ALL who either:are resistant or intolerant to either dasatinib or nilotinib,Or:have the T315I mutation.Secondary Objectives:* To further…
The primary objective is to investigate if there is an incremental inhibiting effect on MSNA by increasing dosage valsartan above the presently advised dosage. We hypothesize that there will be a further decrease in MSNA as compared to the MSNA…
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…
Primary Objective:To characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in patients with CP-CML who are resistant to at least 2 TKIs, as measured by MCyR by 12 months.Key Secondary Objectives:* To…
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…
To demonstrate the efficacy of ponatinib administered at 2 starting doses (30 and 15 mg QD) compared to nilotinib administered at 400 mg BID in patients with CP-CML who are resistant to imatinib, as measured by MMR by 12 months
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…
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…
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 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…
Primary: To assess the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response.
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…
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…
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 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 objectives:Phase 1: To determine the MTD and/or RP2D of oral ponatinib administered QD in pediatric participants with selected advanced hematologic malignancies or solid tumors.Phase 2- Group A (CP-CML): To determine the efficacy of oral…
Primary Objectives:Phase 1 Primary Objective** To determine the RP2D of ponatinib (tablet and AAF) in combination with chemotherapy.Phase 2 Primary Objective* * To determine the efficacy of ponatinib in combination with chemotherapy as measured by…
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.