15 results
Primary Objective: The primary objective of this exploratory trial is to evaluate the comparative safety through Week 12 of two treatment transition strategies in patients with inadequate response to methotrexate: discontinuation of methotrexate…
1. Primary Objectives of the study: The primary objectives of this study are to evaluate the efficacy and safety of 2 SC dosing tiers of ustekinumab in the treatment of adolescent subjects * 12 to < 18 years of age with moderate to severe…
Primary objective: 1. To evaluate the effect of ustekinumab in patients with moderate to severe hidradenitis suppurativa (Hurley II-III), measured by disease specific score systmes: Sartorius/HS-LASI and PGA 2. To evaluate possible changes in scores…
To determine the minimal biologic drug serum trough concentration required to maintain stable disease activity in patientswith moderate to severe chronic plaque psoriasis.
Primary ObjectivesPhase 1 portion:• to determine the maximum tolerable dose (MTD) of cytarabine (up to 2 g/m2/day x 5) that can be administered on Days 8-12 following treatment with DACOGEN 20 mg/m2/day on Days 1-5 of a 28 day cycle. • to determine…
The primary objective of this study is to assess the feasibility (safety and efficacy) of addition of 10-day decitabine to the standard Seattle non-myeloablative conditioning regimen (3 days fludarabine 30 mg/m2 + 2 Gray TBI) prior to allogeneic HCT…
Primary: To demonstrate the superiority of secukinumab in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 90 responders at Week 16, compared to ustekinumab.Secondary: To demonstrate the superiority of secukinumab in…
Primary objectives:• To assess early mortality risk (first 30 days after start of induction therapy) of treatment with decitabine-cytarabine in elderly patients with AML or high risk myelodysplastic syndrome (IPSS >=1.5) with a high risk of…
The primary objective of the study is to assess in patients with primary colon cancer whether short-course pre-operative treatment with decitabine can increase Wnt target gene expression as measured in resected tumors compared to pretreatment…
To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease: is dose reduction non-inferior to the current practice regarding clinical effectiveness? Secondary aims are: to investigate what influence…
The objective of this clinical research study is to evaluate the safety and effectiveness of brodalumab, compared with ustekinumab and placebo, for the treatment of moderate to severe plaque psoriasis.
The primary objectives of this study are to assess whether 80 mg ixekizumab every 2 weeks (Q2W) is:• noninferior to ustekinumab at Week 12 in the treatment of patients with moderate-to-severe plaque psoriasis as measured by proportion of patients…
INDUCTION STUDY Primary Objectives:* To evaluate the efficacy of intravenous (IV) ustekinumab in inducing clinical remission in subjects with moderately to severely active UC.* To evaluate the safety of IV ustekinumab in subjects with moderately to…
The primary objective of this study is to compare, in a randomized phase III trial, the effect of 10-day decitabine at a dose of 20 mg/m2 versus conventional induction chemotherapy (*3+7*) on OS in older AML patients.
To assess and compare efficacy (complete response [CR] rate and overall survival [OS]) between SGI-110 and TC in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.