56 results
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…
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…
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…
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.
To determine the antileukemic activity of combination chemotherapy including bortezomib as reinduction therapy in childhood relapsed/refractory ALL.
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.…
- 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 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:• 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…
Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis…
Primary ObjectiveThe primary objective for this study is to compare the clinical efficacy of weekly abatacept in combination with methotrexate to methotrexate alone in achieving Remission, defined as SDAI less than or equal to 3, at Week 24.…
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…
We think that HIF1α could be an important driving force in ongoing angiogenesis and inflammation as seen in RA. If this is the case HIF1α could be an important therapeutic target in RA.In the present study we plan to include patients with early RA…
The overall aim of the CASA trial is to investigate the role of PLD as adjuvantchemotherapy for older postmenopausal women for whom chemotherapy is indicated, but standard regimens, derived from trials in younger women, are assumed to be too toxic…
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…
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.
The objective of this study is to assess the safety and efficacy of efalizumab combined with methotrexate compared with efalizumab monotherapy in adult patients (aged > 18 years) with moderate to severe psoriasis.
The objective of this study is to evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fasciitis. In addition, we study the effect of this treatment on joint mobility, peripheral blood eosinophilia, functional…
The objectives of this study are as follows:Primary Efficacy Objective:• To assess the effect of PG-760564 on the proportion of patients meeting the American College of Rheumatology 20 response criteria (ACR 20) at 12 weeks;11Secondary Efficacy…