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Evidence-Based Mindset & Physical Therapy for Add-on Treatment of Active Axial Spondyloarthritis: Safety and Efficacy

To investigate whether an add-on mindset & physical therapy program based on the *Wim Hof Method* can safely and efficaciously be applied in patients with active axial spondyloarthritis.

Long Term Observational Study Of The Safety And Efficacy Of An Active Implantable Vagal Nerve Stimulation Device In Patients With Rheumatoid Arthritis

Primary Efficacy ObjectiveThe primary efficacy objective is to determine the long term efficacy of vagal nerve stimulation as assessed by the DAS28 score.Secondary Efficacy ObjectivesThe secondary efficacy objectives are to determine the long term…

Biomarker-guided treatment-and-stop-strategy for recombinant IL-1receptor antagonist (anakinra) in patients with systemic Juvenile Idiopathic Arthritis.

This study has been transitioned to CTIS with ID 2024-518684-35-00 check the CTIS register for the current data. The current project proposal continues on our findings of the performed prospective cohort study, aiming to develop a biomarker guided…

An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima* (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn*s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.

To demonstrate that the infliximab serum concentration of Remsima* is non-inferior to the infliximab serum concentration of Remicade , 16 weeks after switch from Remicade to Remsima* in subjects with CD, UC or RA in stable remission for > 30…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Period 1:The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD and 30 mg QD versus placebo for the treatment of signs and symptoms of subjects with active RA who are on a stable dose of conventional synthetic disease-…

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS

EFFICACY OBJECTIVESThe primary efficacy objective for this study is as follows:* To evaluate the efficacy of TCZ compared with placebo on skin sclerosis, as measured by mRSS at Week 48The secondary efficacy objectives for this study are as follows…

A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) (BEL114055)

Primary: safety and tolerability of belimumab in a pediatric population (5-17 y) with SLE.Secondary: PK, efficacy, quality of life.

A phase 3b, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Double-Dummy, Study of the Efficacy and Safety of Apremilast (CC-10004), Etanercept, and Placebo, In Subjects with Moderate to Severe Plaque Psoriasis

Primary Objective- To evaluate the clinical efficacy and safety of oral apremilast (APR) 30 mg twice a day (BID) compared with placebo, in subjects with moderate to severe plaque psoriasis at Week 16.Secondary Objectives- To evaluate the clinical…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

Period 1: The first objective, of period 1, is to compare the efficacy of ABT-494 15 mg QD versus placebo and versus adalimumab for the treatment of signs and symptoms of rheumatoid arthritis in subjects with moderately to severely active RA who are…

Bright light therapy in rheumatoid arthritis to improve symptoms of fatigue and other disease outcomes: a randomized controlled pilot trial.

The primary objective of this pilot trial is to explore the difference between the intervention and control group in change from baseline (T0) to the end of therapy (T1) in therapy efficacy of the primary study outcome fatigue assessed by Checklist…

A randomized, 2-part, placebo controlled phase 1 study to evaluate safety, tolerability, pharmacokinetics and immunogenicity following single ascending doses (Part 1) and multiple ascending doses (Part 2) of GBR 830 in adult healthy subjects

The purpose of the 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). In addition, the effect…

A single dose clinical trial to study the safety of ART-I02 in patients with rheumatoid 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 in subjects with RA and active arthritis in the wrist.Secondary objectives1.…

A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness

Primary Objective:* To evaluate the safety and tolerability of ARGX-113.Secondary Objectives:* To evaluate the clinical effect of ARGX-113 using:-Myasthenia Gravis-Activities of Daily Living (MG-ADL) score.-Quantitative-Myasthenia Gravis score (QMG…

Fatigue in patients with primary Sjögren*s syndrome

> Can fatigue in pSS patients be explained by force decline during a fatiguing task, muscle activation, mood, and the serum levels of proinflammatory cytokines? > What is the contribution of central factors (muscle activation) and…

Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors.

Primary Objective:To compare the efficacy of BMS-986142 versus placebo on a background of MTX as assessed by ACR20 and ACR70 response rates at week 12.Secondary Objectives:1) Assess additional efficacy outcomes of BMS-986142 at week 12 and over 12…

The effect of TNF blocking therapy on cardiac function in patients with active rheumatoid arthritis

Hypothesis - Our hypothesis is that TNF blocking medication improves cardiac function in patients with active RA. Objectives - Primary objective: to investigate the effect of TNF blocking therapy on diastolic left ventricular (LV) function in RA…

Randomized, double-blind, placebo-controlled phase III study (ASAP III study) to assess the efficacy and safety of Abatacept treatment in patients with primary Sjögren*s syndrome
(ASAP III study = Abatacept Sjögren Active Patients phase III study)

Primary: to assess efficacy of weekly subcutaneous (SC) administration of Abatacept vs. placebo on disease activity assessed with ESSDAI at in patients with pSS. Secondary: to assess efficacy of Abatacept on clinical, functional, subjective, and…

The effectiveness of a sports program on fatigue and QoL in IBD patients with quiescent disease

Primary Objective: - To assess the effectiveness of a sports program on fatigue and quality of life in IBD patients with quiescent disease and chronic fatigue.Secondary Objectives: - To assess the influence of a sport program on the physical fitness…

Compromised mandibular function in Juvenile Idiopathic Arthritis: intervention

To contrast jaw exercises and corticosteroid injection via arthrocentesis in children with JIA and MRI confirmed TMJ arthritis despite 1 year regular treatment by the rheumatologist, in a randomized clinical trial, both in combination with continued…

A Phase 4 Trial Assessing the ImPact of Residual inflammation detected via imaging tEchniques, Drug levels and patient characteristics on the outcome of dose taperIng of adalimumab in Clinical remission rheumatoid arThritis (RA) subjects (PREDICTRA)

The primary objective is to investigate the association between residual disease activity at Baseline as detected by magnetic resonance imaging (MRI) and the occurrence of flares in RA subjects randomized to an adalimumab dose tapering regimen…