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The efficacy of Methotrexate for glucocorticoid dose reduction in recently diagnosed polymyalgia rheumatica patients: a double-blind randomized placebo controlled multicenter clinical trial.

Primary Objective: To determine whether in recently diagnosed PMR patients concomitant treatment to glucocorticoids with MTX 25 mg/week compared to a placebo will lead to a higher proportion of GC-free remission at 52 weeks. Secondary Objectives: To…

Leflunomide and Hydroxychloroquine combination therapy
for primary Sjögren*s Syndrome

This study has been transitioned to CTIS with ID 2024-510904-36-00 check the CTIS register for the current data. To assess clinical efficacy and safety of Leflunomide/Hydroxychloroquine in pSS patients in a phase IIb placebo-controlled randomized…

A Phase 1, Randomized, Single-Center Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of R289 in Healthy Subjects.

Part 1 - Single Ascending Dose (SAD) Capsule Formulation:Primary objective:To investigate the safety and tolerability of single oral doses of R289 capsules in healthy subjects.Secondary objective:To characterize the pharmacokinetic (PK) profiles of…

A randomised, double-blind, placebo controlled, single and multiple dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NMD670 in male and female healthy subjects and patients with myasthenia gravis.

* To assess safety and tolerability of single oral doses of NMD670 in healthy male and female subjects * To assess safety and tolerability of repeated oral doses of NMD670 in healthy male subjects * To assess safety and tolerability of single oral…

Personalized RehabilitatiOn in severly Fatigued patients with Idiopathic inflammatory myopaThies: a pilot randomized controlled trial

To answer the following questions; (1) What is the estimated effect size of personalized rehabilitation therapy for improving daily functioning in severely fatigued myositis patients, compared to usual care? (2) What are the societal costs of…

The effects of rituximab and obinutuzumab on lymphocyte subsets in peripheral blood and lymphoid tissues of SLE patients

This study has been transitioned to CTIS with ID 2024-518965-85-00 check the CTIS register for the current data. The primary objective of this study is to investigate the potential differential effects of RTX and OBI on the composition of lymph…

COBRA re-KAI study: COVID-19 vaccination in patients with reduced B-cell and T-cell immunity: response after re-vaccination of a kaleidoscopic group of hematological patients: what*s the impact?

To answer the following questions: 1. Who are the patients that need to be revaccinated?2. How many vaccinations are needed to restore SARS-CoV-2 immunity?3. Can the number of vaccinations needed to restore SARS-CoV-2 immunity be predicted?To answer…

Switching from intravenous to subcutaneous infliximab in adult patients with inflammatory bowel disease: evaluation of exposure parameters (SHUFFLE-study)

The aim of this study is to evaluate the AUC, disease status, presence of ADAbs and treatment burden when switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients on IFX monotherapy and combination therapy.

Effect of an immune-supportive diet on gut permeability and allergic symptoms in children with peanut and/or nut allergy.

Therefore, the purpose of our study is to study, in peanut and nut allergic children:1. the relationship between gut permeability and threshold levels to peanut or nuts;2. the effect of an immune-supportive diet on gut permeability, coexisting…

EPITOPE OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM
CLINICAL BENEFIT AND SAFETY OF DBV712 IN PEANUT-ALLERGIC
CHILDREN (EPOPEX)

This study has been transitioned to CTIS with ID 2024-515703-19-00 check the CTIS register for the current data. The objectives of this follow-up study of the EPITOPE study are:• To assess the clinical benefit of Viaskin Peanut after up to 3 years…

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

Primary:-To evaluate the efficacy of KEVZARA (sarilumab) in patients with polymyalgia rheumatica (PMR) as assessed by the proportion of subjects with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared…

A Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation with an Intravenous Formulation of ARGX-113 in Healthy Male Subjects.

To compare the pharmacokinetics, pharmacodynamics, safety and tolerability of a subcutaneous formulation with an intravenous formulation of ARGX-113 in healthy male subjects

PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS

Primary Objective:The primary objective of this study is to provide confirmatory data on the beneficial effect of 2.0 g/kg of Octagam 10% given every 4 weeks compared with placebo in subjects with active DM based on the percentage of responders at…

GRAVITAS-301: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft Versus Host Disease

Primary objective: Compare the efficacy of itacitinib in combination with corticosteroids versus placebo in combination with corticosteroids in terms of overall response rate (ORR) at Day 28 in subjects with aGVHD.Secondary objectives:- Compare the…

A multicenter, randomized, open label, efficacy assessor-blinded study of risankizumab compared to secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systematic therapy.

The objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Prospective Analysis of an individualized dosing Regimen of ATG (Thymoglobulin) in Children Undergoing HCT: redUcing Toxicity and improving Efficacy * a single arm phase II study

To investigate whether an individualized dosing regimen for Thymoglobulin leads to a better immune reconstitution after HCT (definition as in primary endpoint), as compared to historically non-individualized treated patients receiving Thymoglobulin…

In vitro Screening of drug candidates against cancer and autoimmune diseases for effects on human blood cells

Primary Objective: Test the capacity of drug candidates to specifically inhibit the signalling pathways they target in human blood cells in vitro in the setting of human whole blood.Secondary Objective(s): Test whether drug candidates exert…

Second IVIg Dose in GBS patients with poor prognosis (SID-GBS trial)

To determine whether a second IVIg course in GBS patients with a poor prognosis improves functional outcome after 4 weeks.

A Phase 4, Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction with Surgery in Subjects with Moderate to Severe Hidradenitis Suppurativa

Primary objective:Assess the safety and efficacy of adalimumab prior to surgery in subjects with moderate to severe HS who are surgical candidates.Secondary objectives:Assess the impact of adalimumab on the planned HS surgical site before surgery,…

The Clinical Efficacy And Subclinical Effects on arterial STIFFNESS of bosentan therapy added to usual care in patients with systemic sclerosis with digital ulcers.

To investigate whether bosentan added to usual care improves arterial stiffness after 3 months as measured as the pulse wave velocity (PWV) of the medium and large arteries corrected for blood pressure changes in patients with SSc with digital…