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Gender differences and changes in body composition during tapering of TNF blockers in patients with ankylosing spondylitis.

Primary objective: to assess gender differences in the risk of flaring after the tapering of TNF inhibition.Secondary objectives: 1. to assess gender differences in body composition in AS patients with sustained low disease activity during TNF-…

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation

Primary ObjectiveTo evaluate the efficacy of lumacaftor/ivacaftor combination therapy (LUM/IVA) in subjects with cystic fibrosis (CF) 12 years of age and older who have at least one A455E mutation.Other Objectives* To explore the association between…

Phase I, Open Label, Single Dose Study to Determine the Pharmacokinetics, Metabolism, and Excretion of [14C]- Evobrutinib in Healthy Participants

The purpose of this study is to investigate how quickly and to what extent evobrutinib is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). Part of the evobrutinib will be labelled with…

AN OPEN-LABEL, NON-CONTROLLED, MULTICENTRE CLINICAL TRIAL OF INHALED MOLGRAMOSTIM IN AUTOIMMUNE PULMONARY ALVEOLAR PROTEINOSIS PATIENTS

The main objective of this trial is to investigate safety of long term use of inhaled molgramostim by collecting information on the side effects.

An open-label, single-sequence study to investigate the effects of BMS-986165 on the single-dose pharmacokinetics of methotrexate in healty male subjects.

The purpose of this study is to investigate the influence of the new compound BMS­986165 on the absorption, distribution, and elimination (this is called pharmacokinetics) of methotrexate (MTX) from the body, when it is administered to healthy…

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…

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…

The BRIDGE-PMR study: B-cell depletion with Rituximab for Dose reduction of Glucocorticoids: Efficacy in PolyMyalgia Rheumatica

The proportion of patients in GC-free remission after 20 weeks.

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

Primary:To evaluate the efficacy of sarilumab in patients with giant cell arteritis (GCA) as assessed by the proportion of patients with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course…

A single dose clinical trial to study the safety of ART-I02 in patients with arthritis

Primary objectiveTo evaluate the safety and tolerability of a single intra-articular administration of ART-I02, a recombinant adeno-associated virus (AAV) type 2/5 vector expressing human IFN-β in patients with RA or OA and active arthritis of the…

A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis

The purpose of the study is to investigate the use of secukinumab (AIN457) treat ment in children from 2 to18 years of age with either active Enthesitis -Related Arthritis (ERA) or Juvenile Psoriatic Arthritis (JPsA) subtypes of Juvenile Idiopathic…

A Phase 3, Randomized, Double-Blind, Study Comparing ABT-494 to Placebo in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD) - SELECT - PsA 2

This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of upadacitinib low dose once daily (QD) and high dose QD versus placebo in participants with moderately to…

A Single and Multiple Ascending Dose, Placebo-Controlled, Double-Blind, Phase 1 Study of KY1005 in Healthy Volunteers

Primary objective:To evaluate the safety and tolerability of KY1005.Secondary objectives:To evaluate the pharmacokinetics (PK) of KY1005 following single and repeat doses.Exploratory objectives:- To evaluate the immunogenicity of KY1005;- To assess…

A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren*s syndrome.

To evaluate the safety and efficacy of subcutaneousbelimumab (GSK1550188) and intravenous rituximab coadministrationin subjects with primary Sjögren*s syndrome.

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…

Modulating regulatory T cell function in Juvenile Idiopathic Arthritis with Vitamin B3 (nicotinamide): a phase I/II trial focusing on safety and feasibility aspects in children with JIA.

NAM, well known as a dietary supplement, has also been extensively studied in humans in a variety of diseases in both children and adults. However, the safety, tolerability of NAM in children with JIA is yet unknown. Furthermore, studies performed…

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…

An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase

To describe the pharmacokinetic (PK) profile and effectiveness of sarilumab in patients with sJIA in order to identifythe dose and regimen for continued development in this population.

Microangiopathy after autologous hematopoietic stem cell transplantation in systemic sclerosis

The primary objective of this study is to describe the effect of HSCT on the microangiopathy of SSc patients by using nailfold capillary microscopy (NCM). The secondary objective is to investigate the correlation between NCM findings and clinical…

An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase

To describe the pharmacokinetic (PK) profile and effectiveness of sarilumab in patients with pcJIA in order to identifythe dose and regimen for continued development in this population.