Search for a trial

A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFα Chimeric Monoclonal Antibody (infliximab, Remicade®) in Combination with Methotrexate in Patients with Very Early Inflammatory Arthritis (DINORA Study)

The primary objective of the study is to demonstrate that patients with very early arthritis have a higher probability of achieving a state of clinical remission at end of infliximab therapy if treated with infliximab plus MTX when compared to MTX…

A Phase I, open-label trial to investigate the pharmacokinetic interaction between TMC125 and two antifungal agents (fluconazole and voriconazole), all at steady-state in healthy subjects.

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…

Anti-CD20 for the retreatment of primary Sjögren*s syndrome in patients who were included in the placebo-controlled double blinded rituximab study

Evaluation of the effect of retreatment with rituximab in 20 patients with primary Sjögren syndrome, and evaluation of the intra-individual effect of rituximab compared to placebo, in 10 patients who received placebo in the double blind randomized…

A Phase IIIB multicentre, randomized, double*blind, double dummy study to compare the efficacy and safety of abatacept administered subcutaneously and intravenously in subjects with rheumatoid arthritis, receiving background methotrexate, and experiencing an inadequate response to methotrexate.

The primary objective for this study is to demonstrate that SC injections of abatacept are non-inferior to IV infusions of abatacept .

A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis

To assess the long-term safety and tolerability (and in particular the infection occurrence) ofACZ885 in patients with rheumatoid arthritis (RA) who participated in the core CACZ885A2204,CACZ885A2206, or CACZ885A2207 studies.

A phase IV open label study in moderate to severe chronic plaque psoriasis subjects transitioning from previous systemic antipsoriasis therapies (methotrexate, cyclosporine, retinoids or PUVA, NBUVB) to Raptiva 1 mg/kg/ week therapy.

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…

A Multi-Center, Randomized, Double-Blind, Placebo ??? Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects with Crohn's Disease Involving the Colon.

To demonstrate the efficacy of adalimumab on mucosal healing in subjects with moderate to severe ileocolonic Crohn's disease and to delineate the safety of adalimumab when administered to subjects with Crohn's disease.

A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.

Investigating the safety of adalimumab when administered in subjects with Crohn*s Disease as well as evaulating the efficacy of adalimumab for the induction and maintenance of clinical remission and fistula closure in subjects with moderate to…

A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNF alfa Chimeric Monoclonal Antibody (Infliximab, Remicade) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis.

Primary: To prove that infliximab in combination with azathioprine is superior to azathioprine alone in rapidly inducing a meaningful renal improvement, defined as a reduction in preoteinuria of at least 50%, in patients with membranous SLE…

Identification of low allergenic apple cultivars and assessment of proper chain conditions in view of apple allergy

Identification of low allergenic apple cultivars and breeding germplasmIdentification of chains in which low allergenicity is preserved and of the critical steps in the chain for preserving low allergenicity.

A randomized, double-blind, placebo-controlled, dose escalation study of the safety, tolerability and pharmacokinetics of AIN457 in rheumatoid arthritis patients with pharmacodynamics assessed in an expanded cohort at the maximum tolerated dose.

The objective of this study is to evaluate the safety, tolerability and pharmacokinetics of AIN457 and to compare the efficacy of AIN457 with placebo, in patients with active RA when administered in combination with a stable dose of methotrexate.…

The influence of Raltegravir (MK_0518) on the pharmacokinetics of single-dose Lamotrigine in healthy male subjects (GRANOLA)

In vitro data indicate that raltegravir is not a substrate of UGT1A4 or UGT2B7, but there is no evidence that raltegravir itself does not influence metabolism of other agents mediated by either UGT1A4 or UGT2B7.

A phase 1, first human exposure, single dose, double-blind, randomized, placebo controlled trial to assess the safety, tolerability, pharmacokinetics and pharmaco-dynamics after oral administration of Org 48775-0 in healthy male volunteers in fasted and fed state, in female healthy volunteers, and in rheumatoid arthritis patients with active disease while on methotrexate treatment.

Primary: To assess the pharmacokinetics and effects of single oral doses of Org 48775-0 in healthy male volunteers, post-menopausal women and RA patients. Secondary:To study the influence of Org 48775-0 on the PK of MTX in RA patientsTo explore gene…

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ALTERNATING PANEL, SINGLE ASCENDING DOSE STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF JTK-656 AND THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF JTK-656 IN HEALTHY MALE SUBJECTS

Primary :To investigate the safety and tolerability of ascending single oral doses of JTK-656 administered to healthy male subjectsSecondary:To determine the pharmacokinetics (PK) of ascending single oral doses of JTK-656 administered to healthy…

A pilot study examining the effect of abatacept in ANCA associated vasculitis (AAV)

Main objective:To assess the relapse rate (defined by clinical and biochemical parameters) over 24 months in patients with acute AAV presenting at first diagnosis of relapse, after 12 months of treatment with abatacept in combination with steroids…

A Randomized controlled trial comparing two different immunoglobulins in the treatment of CIDP.

To investigate if:-Kiovig is at least as effective as Gammagard. (equivalence)-Kiovig has a good side effect profile for CIDP patients.-Whether patients prefer Kiovig to Gammagard.

PHASE II STUDY FOR THE TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE OF THE LIVER OR LUNGS WITH ADJUNCT EXTRACORPOREAL PHOTOIMMUNOTHERAPY

to evaluate the safety and efficacy of ECP as adjunct first-line therapy in patients with newly diagnosed chronic GVHD of the liver or lungs

A PROSPECTIVE RANDOMIZED STUDY ON THE EFFICACY AND SAFETY OF THE PROPHYLACTIC USE OF RITUXIMAB, ADDED TO STANDARD IMMUNOSUPPRESSIVE TREATMENT IN COMPARISON WITH STANDARD IMMUNOSUPPRESSIVE TREATMENT ALONE IN RENAL TRANSPLANTATION

To determine the effect of rituximab, when added to standard immunsuppressive therapy, on the incidence and severity of biopsy-confirmed acute rejection within the first six months after transplantation.

Influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases treated with immunosuppressive therapy

The primary objective of this study is to evaluate the humoral response to influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases (reumatoide artritis and poly- dermato-myositis) treated with…

A randomised, double-blind, placebo controlled, multicentre,
exploratory, pilot, phase II trial of 150 mg
atacicept given subcutaneously in combination with
rituximab in subjects with rheumatoid arthritis.

Primary objective:* To assess the safety and tolerability of combined treatment with atacicept and rituximab insubjects with active rheumatoid arthritis receiving re-treatment with rituximab.Secondary objectives:* To evaluate the effect of combined…