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DEfective HUman SAlivary gland stem cells: the cause of Primary Sjögren*s syndrome?
-DEHUSAPS study-

To assess whether salivary gland stem cell (SGCS) defects are key to salivary gland pathogenesis in pSS.

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 30 mg (QD) and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-…

SIMILAR Trial: Santeon InflixMab biosimILAr Research
A randomized, controlled, double blind, phase 4 noninferiority trial to assess efficacy of Infliximab-biosimilar (Inflectra) compared to Infliximab-innovator (Remicade) in patients with inflammatory bowel disease in remission

The objective of this study is to compare the efficacy of Infliximab-biosimilar to Infliximab-innovator and to demonstrate its noninferiority up to 30 weeks, in patients with ulcerative colitis or Crohn*s disease in remission under treatment with…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis…

A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive

Primary ObjectiveThe primary objective for this study is to compare the clinical efficacy of weekly abatacept in combination with methotrexate to methotrexate alone in achieving Remission, defined as SDAI less than or equal to 3, at Week 24.…

Characterization and localization of microstructural changes in brain tissue in Neuropsychiatric Systemic Lupus Erythematosus (NPSLE)

• To increase the sensitivity of the current MRI methods for detecting the changes caused by NPSLE through the scans made on the 7 Tesla scanner, since the higher field strength will lead to a higher signal to noise ratio and higher resolution. • To…

A two part, phase 1, randomised, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of GBR 830 in adult healthy volunteers (Part 1) and a randomised, placebo-controlled, pharmacodynamic study to evaluate the effect of single dose of GBR 830 on vaccination response in adult, healthy volunteers (Part 2)

The purpose of this study is to investigate to what extent GBR 830 is tolerated. It will also be investigated how quickly and to what extent GBR 830 is absorbed and eliminated from the body (this is called pharmacokinetics) and to what extent the…

*IBDome; Identification of rare variants in candidate genes and regulatory elements in familiar and sporadic early-onset IBD (inflammatory bowel disease) patients*

Primary Objective: Identification of rare variants in candidate genes and regulatory elements in pediatric IBD patients. Secondary Objective(s): To determine the functional consequences of identified genetic variants in IBD, we will correlate…

Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…

The oral and gut microbiome in patients with primary Sjögren's syndrome - a pilot study

Primary objective: To identify specific bacteria or a characteristic bacterial composition in the oral and gut microbiome of pSS patients compared to non-Sjögren*s syndrome sicca (non-SS sicca) patients, SLE patients and healthy controls.Secondary…

An open-label, parallel-group, single-dose study to evaluate the absolute bioavailability and tolerability of subcutaneous UCB4940 in healthy subjects

The purpose of the study is to investigate how quickly and to what extent an injection under the skin (subcutaneous [sc]) of UCB4940 is absorbed and eliminated from the body (this is called pharmacokinetics) in comparison with the absorption and…

CD4+ T cells and immune ageing; major players and predictors for disease activity in giant cell arteritis

Primary Objective: to study the differences in CD4+ T cell subsets (Th1/Th2/Th17/Tregulatory/Tsenescent) between GCA patients and healthy controls at diagnosis and during follow up and in remission. Secondary Objective(s): - To characterize the cell…

Unravelling intestinal inflammation: from Celiac Disease genotype to autoimmunity.

The primary aim of the current proposal is to get a better understanding of how CeD risk genes contribute to disease aetiology. To achieve this, we will apply a holistic approach in which we will study the behaviour of immune cells and the…

A randomized, double-blind, placebo-controlled trial of golimumab+methotrexate versus methotrexate alone in methotrexate-naïve patients with psoriatic arthritis

1) to demonstrate the safety and efficacy of golimumab + MTX versus MTX alone in DMARD naïve PsA patients2) to demonstrate that golimumab + MTX is superior to MTX alone to achieve low to very low disease activity in DMARD naïve PsA patients3) to…

The Role of Conditioning for Pharmacotherapeutic Treatments in Rheumatoid Arthritis.

This study aims to enhance pharmacotherapeutic effects in patients with recent-onset RA by means of conditioning (via a variable reinforcement schedule).

Immunological causes of recurrent miscarriages.

Does humoral and/or cellular rejection play a role in recurrent miscarriage of unknown etiology?Can biomarkers of humoral and/or cellular rejection be used for the detection of patients who are likely to suffer a miscarriage in a next pregnancy?

The future of coeliac disease: immunology, environment and possibilities for new treatments.

The primary objective of CDfuture is to provide duodenal biopsies of patients with and without CD, and venous blood samples, to continue CD research as described above.

The effect of Vitamin D3 to prevent postoperative relapse of Crohn*s Disease: a placebo-controlled randomized trial (DETECT)

This trial will provide definitive answers with regard to the anti-inflammatory effects of Vitamin D in Crohn*s disease.

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

The purpose of this study is to investigate the effectiveness and safety of riociguat (BAY 63-2521) in patients with diffuse cutaneous systemic sclerosis.

Therapeutic drug monitoring in tocilizumab-treated rheumatoid arthritis patients: Pilot study of a double-blind randomised controlled trial

To evaluate the feasibility of the study after 20 weeks of follow-up, which includes the evaluation of the dose-reduction algorithm in tocilizumab-treated patients with RA.