39 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…
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…
- 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…
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…
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…
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 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…
Our aim is to optimize treatment for patients with moderate to severe psoriasis by creating evidence for the optimal dose of MTX (on short- and long-term) with the largest disease reduction and the least side effects.
(1) To asses the influence of P-gp function at the BBB on flumazenil binding to the GABAA-receptor in pharmacoresistant patients with temporal lobe epilepsy (TLE), using PET and [11C]flumazenil as a ligand and tariquidar as P-gp blocker. (2) If we…
Are there differences is efficacy, side effects, tolerance en costs in patients with early RA in treatment with COBRA-light compared with COBRA according to BeSt?
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…
To compare the efficacy and safety of methotrexate versus azathioprine treatment in adult patients with chronic severe AD.
Our main aim is to evaluate the effectiveness and cost-effectiveness of two tapering strategies:(i)DMARD tapering and (ii)anti-TNF tapering in RA patients with DMARD&anti-TNF(etanercept, adalimumab, certolizumab or golimumab) induced…
This study*s objective is to reduce MTX related side effects with pharmacotherapeutic conditioning, by using variable reinforcement principles in patients with JIA. Pharmacotherapeutic conditioning enables to alternate standard MTX dosing with lower…
To investigate whether tapering MTX first, then the TNFi golimumab (GOL), is more efficacious than tapering GOL first, then MTX, in sustaining remission and reaching drug free remission.
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.