12 results
Primary ObjectiveTo assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.Secondary Objectives• To estimate…
Primary: To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated PBPK and pop PK approaches
Primary objectives: To evaluate the expression of inflammatory cytokines in HS lesional skin at week four (t=4) and week sixteen (t=16): - of subjects receiving apremilast compared to subjects receiving placebo;- within both groups relative to…
Primary Objective- To evaluate the clinical efficacy and safety of oral apremilast (APR) 30 mg twice a day (BID) compared with placebo, in subjects with moderate to severe plaque psoriasis at Week 16.Secondary Objectives- To evaluate the clinical…
To investigate the efficacy (and the toxicity) of Glivec in systemic sclerosis by examining clinical outcomes (clinical and laboratory findings).
The primary objective of this study is to evaluate whether surgery of residual disease in patients iwth advanced GIST responding to Imatinib improves the progression free survival.The secondary objective is to correlate the pharmacokinetics of…
Primary ObjectiveTo evaluate the clinical efficacy of apremilast (30 mg twice daily [BID] and 40 mg BID), compared with placebo, in subjects with active UC.Secondary Objective To evaluate the safety and tolerability of apremilast (30 mg BID and 40…
Primary: To compare the proportion of patients demonstrating Major Molecular Response (MMR) at 12 months (48 weeks) in the bosutinib arm with that of the imatinib arm in newly diagnosed Philadelphia chromosome positive (Ph+) chronic phase (CP)…
Primary Objective• To evaluate the efficacy of apremilast 30 mg BID * NSAIDs and/or csDMARDs vs. Placebo * NSAIDs and/or csDMARDs in subjects with early oligoarticular PsA, assessed by modified MDA (MDA-Joints).Secondary Objectives · To evaluate the…
The main objective of study 20190530 is to estimate the efficacy of Apremilast compared to placebo in the treatment of oral ulcers in pediatric subjects from 2 to < 18 years of age with oral ulcers associated with BD through week 12. See…
Primary ObjectiveThe primary objective of the study is to evaluate the clinical efficacy of apremilastcompared with placebo in children and adolescents (ages 6 through 17 years) withmoderate to severe plaque psoriasis.Secondary Objectives- * To…
Estimate the efficacy of apremilast compared with placebo in the treatment of Juvenile Psoriatic Arthritis (JPsA) in pediatric subjects 5 to less than 18 years of age.Refer to section 3 of the protocol for more information.