29 results
Primary Objective During Double-Blind Period:To compare the efficacy of BMS-945429 SC versus placebo on a background of methotrexate as assessed by ACR20 response rates at 12 weeks.Secondary Objectives During Double-Blind Period:1) To assess…
The aim of this study is to explore the incidence of MTX related gastro-intestinal in a large cohort of JIA patients. Secondly, we want to investigate the effect of psychological behavioural therapy or switch to parenteral MTX dosing to ameliorate…
Primary objective:• Phase Ib: to assess the feasibility and safety of the addition of cetuximab to methotrexate for recurrent or metastatic SCCHN • Phase II: to assess the efficacy of the addition of cetuximab to methotrexate for recurrent or…
- The main hypothesis of this study is that JIA patients at risk of a flare due to subclinical inflammatory activity may be identified by analysis of the phagocyte activity marker S100A12 and hsCRP. The goal is a stratification of the therapeutic…
The study has the following 3 main objectives pertaining to the treatment of DMARD-naïve subjects with adult-onset, early, active, RA, diagnosed within 1 year before Screening using the 2010 ACR/EULAR RA classification criteria:1.To show that…
The study aims to limit the use of anthracyclines and to reduce the dose of ATRA. Another aim is to stratify treatment by risk group: standard risk - WBC <10 x 109/l : high risk - WBC >=10 x 109/l. Furthermore this study aims to…
Primary objective: to evaluate the efficacy of subcutaneous application of methotrexate in patients with moderate to severe Psoriasis compared to Placebo as assessed by achieving the primary endpoint PASI 75 after a 16 week treatment phase.…
To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of nelarabine, etoposide and cyclophosphamide when given in combination to children with T-ALL and bone marrow relapse or T-LL.
The objectives of this study are to determine the safety and efficacy of two doses of adalimumab versus MTX in paediatric subjects with chronic plaque psoriasis, to determine the time to loss of disease control and the ability to regain response…
Primary Objectives:(1) Objective: To compare the overall survival (OS) in subjects with R/M HNSCC treated with pembrolizumab compared to standard treatment.Secondary Objectives:PD-L1 Positive Population:(1) Objective: To compare Overall Survival (OS…
Primary: *To assess if combination therapy of adalimumab and MTX significantly improves the drug survival at one year compared to adalimumab monotherapy in patients with moderate-to-severe psoriasis.Secondary: *To assess if combination therapy of…
The objective of this study is twofold. First, we want to investigate the effectiveness of a COBRA-plus therapy after incomplete response on COBRA-light therapy after 13 weeks to improve the percentage of RA-patients with a high disease activity and…
This is an open, non comparative, multicentre phase II trial, to evaluate the efficacy and feasibility of a newsequential combination of HD-MTX-AraC-based chemoimmunotherapy, followed by R-ICE regimen, and byhigh-dose chemotherapy supported by ASCT.
The objectives are:1. the effect of steady state concentrations of voriconazole and fluconazole on the steady-state pharmacokinetics of TMC125,2. the effect of steady-state concentrations of TMC125 on the steady-state pharmacokinetics of…
To compare the efficacy and safety of methotrexate versus azathioprine treatment in adult patients with chronic severe AD.
To determine the antileukemic activity of combination chemotherapy including bortezomib as reinduction therapy in childhood relapsed/refractory ALL.
The objectives of this study are:* To determine the percentage of patients with recent-onset RA and UA who achieve and maintain clinical remission on treatment with a combination of methotrexate 25 mg/week and extended prednisone pulse (tapered high…
Objectives. The goals of the current protocol is therefore the natural follow-up of the objectives achieved with the previous grants and, in particular, of projects designed to discern new models for the successful conduct of clinical trials in…
Objectives:To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose. The secondary objective is to…
To compare the short-term and long-term clinical efficacy, safety and tolerability of ABT-874 compared to MTX in the treatment of moderate to severe chronic plaque psoriasis over a 24 and 52-week period.