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Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis

To investigate the effect of CTLA4-Ig (abatacept) on phenotype, transcriptional profile, B cell receptor usage and functional parameters of circulating B cells expressing anti-citrullinated protein antibodies (ACPA) in patients with early,…

A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjögren*s Syndrome

To determine the dose-response relationship of VAY736 for key efficacy and safety parameters.

Intravenous immunoglobulin and prednisone vs. prednisone in newly diagnosed myositis: a double blind randomized clinical trial.

This study has been transitioned to CTIS with ID 2024-516057-42-00 check the CTIS register for the current data. The primary aim is to examine whether early addition of IVIg to standard treatment with prednisone in patients with newly diagnosed…

A first-in-human, randomized, subject-blinded, placebocontrolled, single ascending dose study to investigate the safety, tolerability and pharmacokinetics of MHS552 in healthy volunteers

To assess the safety and tolerability of MHS552 of single i.v./s.c. doses. Cohort 1-5 will be i.v. and cohort 6-8 will be s.c. In addition, in each of the 5 first cohorts, a sentinel group is included.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

Primary Efficacy Objective:To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing the American College of Rheumatology (ACR) Provisional Combined Response Index in diffuse cutaneous Systemic Sclerosis (CRISS)…

A single dose, randomised, double-blind parallel group study to compare the pharmacokinetics and pharmacodynamics of PB006 with Tysabri® in healthy subjects

The sponsor is developing a compound (PB006) similar to Tysabri® (natalizumab, hereafter referred to as Tysabri). As part of medical-scientific studies to confirm the similarity of the two compounds, the Sponsor wants to compare PB006 with EU-…

A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER)

Part 1 - To determine effects of different ianalumab doses on ALT normalization at Week 24 in patients with AIH who are incomplete responders or intolerant to standard therapy.Part 2 - To confirm the efficacy (biochemical and histological remission…

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…

52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or an intolerance to ursodeoxycholic acid (UDCA)

Primary: • To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placeboKey Secondary: • To evaluate the effect of seladelpar on…

A randomized, double-blind, placebo-controlled single and multiple ascending dose study of the safety, tolerability and pharmacokinetics of oral doses of SAR443122 in healthy adult subjects.

This study will be performed in a maximum of 97 healthy volunteers. The study will be performed in 2 parts, Part 1 (split up in Part 1a and Part 1b) and Part 2. A single dose of SAR443122 (or placebo [only in Part 1a]) will be administered in Part 1…

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus.

To evaluate the effect of baricitinib 4-mg QD and background standard-of-care therapy compared with placebo and background standard-of-care therapy on SLE disease activity.

Handscan optical measurements in Rheumatoid Arthritis: an inventory comparing serum levels of CRP, ESR, IL-6, clinical arthritis and reproducibility of DAS28.

2.1 Primary ObjectiveDescribing the association between Handscan optical scores, markers of inflammation (levels of CRP, serum IL-6) and clinical swollen joint score in three treatment groups with different pharmacokinetic modes of action for RA…

PeRsonalIzed MEdicine in Rheumatoid Arthritis (PRIMERA trial): a multicenter, single-blinded, randomized controlled trial comparing usual care with a tailor-made approach

This study has been transitioned to CTIS with ID 2024-511530-12-01 check the CTIS register for the current data. We hypothesize that treatment of RA can be individualized by taking into account the presence of autoantibodies and quick response to…

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…

An international, randomised, open label trial comparing a rituxmab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, 'generalised' ANCA associated vasculitis

To assess the rates of preliminary response and sustained remission of AASV following rituximab (on the basis of former studies, 86% sustained remission expected with rituximab compared to 75% in control group).To assess safety of a rituximab…

The efficacy of Methotrexate for glucocorticoid dose reduction in recently diagnosed polymyalgia rheumatica patients: a double-blind randomized placebo controlled multicenter clinical trial.

Primary Objective: To determine whether in recently diagnosed PMR patients concomitant treatment to glucocorticoids with MTX 25 mg/week compared to a placebo will lead to a higher proportion of GC-free remission at 52 weeks. Secondary Objectives: To…

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…

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…

Regulation of the stress-axis by vitamin D3 in subjects with multiple sclerosis; a double-blinded, randomized, placebo-controlled study

The main aim of this study is to assess hypothesis A, and we will perform an exploratory analysis on hypothesis B.

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