Search for a trial

A multi-centre, randomized, double-blind (sponsor open), placebocontrolled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis (study 201247)

Primary:To evaluate the safety and tolerability of repeat subcutaneous doses of GSK2330811 in participants with dcSSc.Secondary:PK. PD (serum levels of total and free OSM). Antibodies against GSK2330811.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active
Ulcerative Colitis

The objective of Study M14-675 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg once daily (QD) compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely…

Dose REduction Strategy Study of TNF inhibitors in Psoriatic arthritis and axial Spondyloarthritis patients.

The aim of the study is to compare the proportion of patients (for PsA and axSpA together) having LDA at 12 months between a T2T strategy with versus without tapering attempt against a pre-set non-inferiority margin of 20%.

A phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with early, oligoarticular psoriatic arthritis despite initial stable treatment with either non-steroidal anti-inflammatory drugs (NSAIDs) and/or <=1 conventional synthetic disease-modifying antirheumatic drugs (DMARD).

Primary Objective• To evaluate the efficacy of apremilast 30 mg BID * NSAIDs and/or csDMARDs vs. Placebo * NSAIDs and/or csDMARDs in subjects with early oligoarticular PsA, assessed by modified MDA (MDA-Joints).Secondary Objectives · To evaluate the…

MRI for MMN and CIDP - Towards improved diagnostic accuracy and dissection of pathophysiology.

1. To study reproducibility of a qualitative scale for abnormality of brachial plexus MRI.2. To study usefulness of quantification of nerve size using maximum intensity projection techniques (MIP) , and compare results with HRUS of the brachial…

PRACTICAL study: Pharmaco-enhancement in Rheumatoid Arthritis with Cobicistat to dose Tofacitinib In Clinic Adequately Low. A within-subject sequential study.

The aim of this study is to investigate the use of cobicistat to reduce the required dose and dose frequency of tofacitinib in the treatment of RA.

A multicentre study for the long-term follow-up of HLH patients who received treatment with NI-0501, an anti-interferon gamma monoclonal antibody

Study Objectives:* To monitor the long-term safety profile of NI-0501* To assess HLH patients* survival after NI-0501 treatment* To assess duration of response to NI-0501 treatment (i.e. maintenance of HLH control)* To assess post-HSCT outcome…

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…

T cells and innate lymphoid cells (ILCs) in cutaneous graft-versus-host disease

The overall aim of the study is to improve our understanding of the role of T cells and ILCs in cutaneous GvHD, to lay the foundation for the development of better therapies to treat cutaneous GvHD.1. T cells in GvHDThe dominant cell population in…

Timing of umbilical cord clamping during an elective caesarean delivery and its association with neonatal gut microbiome

Primary Objective: To compare the composition and functionality of neonatal microbiome arising from mothers receiving antibiotic prophylaxis before skin incision with the microbiome of neonates born when antibiotics are given after umbilical cord…

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…

Bioavailability of phosphorus after oral intake of two hypoallergenic infant formulas in healthy adult volunteers with a neutral stomach pH

This study's objective is to assess the bioavailability of phosphorus after oral intake of a new hypoallergenic infant formula compared to the bioavailability of phosphorus after oral intake of another hypoallergenic infant formula.

An assessment of nutritional deficiencies in patients with primary antibody deficiency and bronchiectasis.

Primary Objective: To assess dietary intake of macro- and micronutrients, body composition and serum levels of nutrients in patients with primary antibody deficiency and bronchiectasis. Secondary Objective(s): - To evaluate the correlation between…

A Phase 1, Open-Label, Non-Randomized, 2-Period, Fixed Sequence Study to Investigate the Absorption, Distribution, Metabolism and Excretion of [14c-Pf-06700841] and to Assess the Absolute Bioavailability and Fraction Absorbed of Pf-06700841 in Healthy Male Subjects using a 14C-Microtracer Approach

The purpose of this study is to investigate how safe the new compound PF-06700841 is and how well it is tolerated when it is administered to healthy volunteers. PF-06700841 has been administered to humans before. It will also be investigated how…

IgG4:IgG mRNA ratio as disease activity marker in vasculitis

Aim 1: Confirm the hypothesis that the IgG4 qPCR test score correlates with disease activity in vasculitis as observed in the pilot study. Aim 2: Study IgG4-expressing B-cells from blood of vasculitis patients to understand their role in the…

Detection of retinal and peripheral microvascular abnormalities in ankylosing spondylitis patients * a proof of concept study.

Primary objective: To investigate whether AS patients have increased signs of microvascular abnormalities of the retina, compared with healthy controls.Secondary objectives: to investigate:1. the peripheral microvascular function in AS patients,…

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 multicenter randomized placebo controlled treatment study of leflunomide in polymyalgia rheumatica

This study has been transitioned to CTIS with ID 2024-514210-12-00 check the CTIS register for the current data. To investigate whether the use of leflunomide can prevent relapses during glucocorticoid tapering in patients with polymyalgia…

A Phase 1, Randomized, Single-Center Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of R948835 in Healthy Subjects

Primary objectives:Part A: To investigate the safety and tolerability of single ascending oral doses of R835 in healthy subjects.Part B:To investigate the safety and tolerability of multiple ascending oral doses of R835 in healthy subjects.Part C:…

Characterizing the myocardium of Systemic Sclerosis patients with pulmonary hypertension using CMR parametric mapping

To evaluate the presence and extent of myocardial inflammation, fibrosis and myocardial perfusion in SSc patients with either PH-LHD or PAHPAH and/or PH-LHD, in comparison to patients with idiopathic pulmonary arterial hypertension (IPAH) by means…