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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…

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.

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.

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…

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…

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.

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…