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Optimizing DMARD therapy for primary Sjogren's Syndrome - Leflunomide and Hydroxychloroquine combination therapy for patients with primary Sjogren's Syndrome

In a clinical trial it will be investigated to what extent combination therapy with LEF and HCQ will 1) inhibit disease activity, in particular improvement of ESSDAI and dryness and 2) inhibit activity of (autoreactive) B-cells, T-cells and pDCs. In…

A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis

Primary objective: To assess efficacy and safety (treatment of signs and symptoms) of Nanocort in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation in comparison to a standard of care medication (Depo-Medrol).…

EMDR treatment for anxiety related to the future in MS patients

The objective of this study is to examine whether EMDR with flashforward targets can be effective in reducing anxiety related to the future in MS patients. Specifically, following hypotheses will be examined: EMDR with flashforward target…

Understanding variability of immune responses to BCG vaccination: a systems biology approach

To elucidate the host and environmental factors that influence the magnitude of the individual trained immunity responses to BCG vaccination using a systems biology approach.

A study to characterize the humoral and cellular response following simultaneous immunization with a neo-antigen (KLH) and a recall antigen (tetanus) in healthy volunteers

Investigation of the immune response following immunization with Immucothel/Alhydrogel with or without tetanus. Per efficacy endpoint, the following parameters will be explored:(a) Response size;(b) Inter-individual variability of the response;(c)…

Molecular Diagnostics in Rheumatoid Arthritis (MODIRA) cohort: Validation of predictive tools for prognosis and treatment strategies in rheumatoid arthritis, a multi-centre cohort study

to combine and validate diagnostic tests for the prediction of clinical response to therapy with biologics in patients withreumatoid artritis.

PEANUT ALLERGY ORAL IMMUNOTHERAPY STUDY OF AR101 FOR DESENSITIZATION IN CHILDREN AND ADULTS (THE PALISADE STUDY)

The primary objective is to demonstrate the efficacy of AR101, a pharmaceutical-grade peanut allergen formulation, through reduction in clinical reactivity to limited amounts of peanut allergen in peanut-allergic children (ages 4-17 years, inclusive…

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- And Active-Controlled Study Followed By A Placebo-Controlled Maintenance Period And Open-Label Follow-Up To Evaluate The Efficacy And Safety Of Certolizumab Pegol In Subjects With Moderate To Severe Chronic Plaque Psoriasis

(Protocol v1.0 25Jul2014 p.18) The primary objective of the study is to compare the efficacy of certolizumab pegol (CZP) administered subcutaneously at the doses of CZP 400mg every two weeks and CZP 200mg every two weeks after a loading dose of CZP…

Mechanism of action study of Ustekinumab treatment in psoriatic arthritis:
Impact on cellular and molecular pathways of synovial inflammation and tissue remodeling

ObjectivePlease describe:• the specific goal to be reached by the study• the hypothesis to be answered by the studyThe overall aim of the study is to determine which downstream cellular and molecular pathways involved in PsA pathogenesis are…

Performance of the HandScan in tight control treatment of Rheumatoid Arthritis

Primary: to compare improvement on the Health Assessment Questionnaire (HAQ) between HandScan guided tight control and treat-to-target treatment and the conventional ACR/EULAR remission guided tight control and treat-to-target treatment of RA after…

RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization

To assess the difference in efficacy between two ultra-low doses (1 x 500 mg and 1 x 200 mg) and standard low dose (1 x 1000 mg) of RTX retreatment on the change in DAS28-CRP, compared to a pre-specified non-inferiority margin of 0.6, at 3 and 6…

Gender differences and changes in body composition during tapering of TNF blockers in patients with ankylosing spondylitis.

Primary objective: to assess gender differences in the risk of flaring after the tapering of TNF inhibition.Secondary objectives: 1. to assess gender differences in body composition in AS patients with sustained low disease activity during TNF-…

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation

Primary ObjectiveTo evaluate the efficacy of lumacaftor/ivacaftor combination therapy (LUM/IVA) in subjects with cystic fibrosis (CF) 12 years of age and older who have at least one A455E mutation.Other Objectives* To explore the association between…

Phase I, Open Label, Single Dose Study to Determine the Pharmacokinetics, Metabolism, and Excretion of [14C]- Evobrutinib in Healthy Participants

The purpose of this study is to investigate how quickly and to what extent evobrutinib is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). Part of the evobrutinib will be labelled with…

AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS

The main objective of this trial is to investigate safety of long term use of inhaled molgramostim by collecting information on the side effects.

An open-label, single-sequence study to investigate the effects of BMS-986165 on the single-dose pharmacokinetics of methotrexate in healty male subjects.

The purpose of this study is to investigate the influence of the new compound BMS­986165 on the absorption, distribution, and elimination (this is called pharmacokinetics) of methotrexate (MTX) from the body, when it is administered to healthy…

Training immune functions through pharmacotherapeutic conditioning in
juvenile idiopathic arthritis

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…

A Phase 1 Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IV SYNT001 in Healthy Volunteers.

Primary objectives* To evaluate the safety and tolerability of multiple SYNT001 loading and maintenance doses in healthy subjects.* To determine the multiple dose pharmacokinetics (PK) of SYNT001 in healthy subjects.Secondary objectives* To evaluate…

The BRIDGE-PMR study: B-cell depletion with Rituximab for Dose reduction of Glucocorticoids: Efficacy in PolyMyalgia Rheumatica

The proportion of patients in GC-free remission after 20 weeks.

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis

Primary:To evaluate the efficacy of sarilumab in patients with giant cell arteritis (GCA) as assessed by the proportion of patients with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course…