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A phase 1, randomized, open-label, parallel group trial to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of different single subcutaneous dose levels of Efgartigimod co administered with rHuPH20 in healthy adult male subjects

The purpose of this study is to investigate the effects of the new compound efgartigimod on IgG antibodies. It will also be investigated how quickly and to what extent efgartigimod given together with rHuPH20, is absorbed and eliminated from the…

A phase 1, open-label, non-randomized, 2-period, fixed sequence study to investigate the absorption, distribution, metabolism and excretion of 14C-PF-06651600 and to assess the absolute bioavailability and fraction absorbed of PF-06651600 in healthy male participants using a 14C-microtracer approach

The purpose of this study is to investigate how quickly and to what extent PF-06651600 is absorbed and eliminated from the body (this is called pharmacokinetics). In this study doses of PF-06651600 labeled with very low doses radioactive (14C) will…

A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

The primary objective of this study is:* To evaluate the long-term safety and tolerability of filgotinib in subjects who have completed one of the parent studies of filgotinib in RA.The secondary objectives of this study are:* To evaluate the long-…

Biopsy in Adult CeD (Bio.A.CeD)- the ESsCD Consensus

Prevalence of CeD is about 15 around the world with a variation from 1:100 to 1:300 in different geographical areas [2, 3]. The diagnosis is made out of case finding among at-risk population such as diarrhea, anemia, ibs-like abdominal complaints,…

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to
Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with
Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or
Branebrutinib Treatment Followed by Open-label Abatacept Treatment in
Subjects with Active Rheumatoid Arthritis.

pSS: • To compare the efficacy of branebrutinib with PBO at Week 24 in the treatment of subjects with pSS• To compare the safety and tolerability of branebrutinib with PBO in subjects with pSSRA: • To compare the efficacy of branebrutinib with PBO…

RECALL study BeSt and IMPROVED

The objective is to evaluate long-term outcomes in patients with early RA or undifferentiated arthritis (UA) after initial targeted treatment aimed at low disease activity or remission. Moreover, we aim to further establish benefits and possible…

Childhood Lupus cohort study

To initiate a Dutch cohort with standardized follow-up measures and investigating blood, liquor, urine samples and videocapillaroscopy findings (nailfold and under the tongue) for prognostic factors during disease quiescence and at times of disease…

Progression of fibrosis in treated autoimmune hepatitis

Identify markers predicting progression of fibrosis in treated autoimmune hepatitis patients

[18F]fluor-PEG-folate PET/CT imaging in Giant Cell Arteritis.

Primary Objective: to evaluate arterial [18F]fluor-PEG-folate uptake on PET/CT in patients with active, large vessel GCA; and in the same patients after 9 months of standard treatment.Secondary objectives are:- Assessment of the relationship between…

Cross-sectional study for evaluation of Platelet function and Immune profile in patients with Chronic ITP

To assess platelet function and coagulation parameters in adult chronic ITP patients in relation to their bleeding phenotype

[18F]PEG-Folate PET-CT imaging for monitoring of therapy response in Rheumatoid Arthritis patients

This study has been transitioned to CTIS with ID 2024-513537-21-00 check the CTIS register for the current data. To investigate the association between quantitative changes in whole body F-18-PEG Folate PET/CT (Folate PET) after 4 weeks and clinical…

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)

Primary* The primary objective of this study is to determine the long term safety and tolerability of tofacitinib for treatment of the signs and symptoms of JIA.Secondary* The secondary objective of this study is to evaluate the persistence of…

A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and
tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and
adults with macrophage activation syndrome (MAS) in Still*s disease (including systemic
juvenile idiopathic arthritis and Adult onset Still*s disease) or with MAS in Systemic lupus
erythematous

This study has been transitioned to CTIS with ID 2024-516153-52-00 check the CTIS register for the current data. Primary objective: To demonstrate efficacy of emapalumab in the treatment of patients in:• Cohort 1: Macrophage activation syndrome (MAS…

Taxonomy, Treatment, Targets and Remission (3TR): Systemic Lupus Erythematosus study

1. To determine biomarkers of response and non-response to treatment for active SLE in a prospective study where patients will be allocated to therapy according to current clinical practice and the EULAR guidelines (response biomarker study; 3TR SLE…

Can we improve the management of Juvenile PsA patients by using a different disease activity measure?

Primary goal: to determine whether a combined disease activity measure correlates better with disease burden than the current disease measure. Primary study question: does the minimal disease activity JADAS (MDA-JADAS) correspond to the MDA…

PRediction Of Flares In Lupus with autoantibodiEs and chemokines (PROFILE)

The primary objective of this study will be to prospectively evaluate the predictive value of a combination of chemokines, MMPs/TIMPs, and autoantibody levels for predicting flares in patients with SLE. This approach allows identification of the…

A PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION

Part APrimary Objective:• The primary objective of Part A is to determine whether BIVV009 administration results in a >= 2 g/dL increase in hemoglobin (Hgb) levels or increases Hgb to >= 12 g/dL and obviates the need for blood…

A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of emapalumab, an anti-interferon gamma (anti-IFNγ) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still*s Disease (AOSD) developing Macrophage Activation Syndrome/ secondary HLH (MAS/sHLH)

The aim of this study is to investigate how safe, effective, and well-tolerated multiple infusions of the experimental study treatment, emapalumab (the study medication) are in controlling this disease, as well as to check the concentrations of…

The RTX-COVAC study: humoral response to COVID-19 vaccination after rituximab, and relation with dose and vaccination timing. A prospective cohort study.

To investigate, in RA patients, the role of different RTX doses (200, 500 and 1000mg) and timing of RTX on risk of obtaining adequate humeral response against COVID-19 vaccines, by performing a sensitivity analysis on response, using logistic…

A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE)

The primary objective is to characterize the PK profile of belimumab 200 mg SC in pediatric SLE participants.The secondary objectives are to evaluate the safety and tolerability of belimumab 200 mg SC in pediatric SLE participants and to…