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A phase-3, randomized, double-blind, study comparing Risankizumab to Placebo in subjects with active psoriatic arthritis (PsA) who have a history of inadequate response to or intolerance to at least on disease modifying anti-rheumatic drug (DMARD) therapy (KEEPsAKE 1)

The primary objective of the study is to compare the efficacy of risankizumab versus placebo for the treatment of signs and symptoms of PsA in subjects who have a history of inadequate response to or intolerance to at least one conventional…

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE NONRADIOGRAPHIC AXIAL SPONDYLOARTHRITIS

Objective(s): Primary objective:The primary objective is to demonstrate the efficacy of bimekizumab administered subcutaneously every 4 weeks (sc Q4W) compared to placebo in the treatment of subjects with active nr-axSpA.Secondary objectives:The…

A phase 3, randomized, double-blind, multicenter, placebo-controlled study of Inebilizumab efficacy and safety in IgG4-related disease

This study has been transitioned to CTIS with ID 2023-508290-81-00 check the CTIS register for the current data. Primary objective: To evaluate the efficacy of inebilizumab in reducing the risk of a disease flare in patients with IgG4-RD.Secondary…

A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy

This study has been transitioned to CTIS with ID 2024-512785-33-00 check the CTIS register for the current data. Primary objective: To evaluate the clinical improvement of efgartigimod PH20 SC treatment compared with placebo, in addition to standard…

A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis

Primary Objective:The primary objective of this study is to compare the efficacy of bimekizumab administered scfor 16 weeks versus secukinumab at achieving complete clearance (PASI100) in subjects withmoderate to severe chronic plaque PSO.The…

Three randomized controlled trials with a two-year extension period on the effect of a multidisciplinary lifestyle program (1) for patients with rheumatoid arthritis, (2) for patients with ACPA positive arthralgia and (3) patients with osteoarthritis & metabolic syndrome.

Investigating the effect of a 16 week multidisciplinary lifestyle programme, based on (1) a whole foods plant based diet (WFPD), (2) exercise and (3) stress management on:- disease activity (DAS28) for patients with rheumatoid arthritis (RA), in…

A multicenter study of secukinumab, with a randomized double-blind, placebo-controlled withdrawal-retreatment period, to evaluate maintenance of response in participants with non-radiographic axial spondyloarthritis who achieved remission

This study has been transitioned to CTIS with ID 2023-509320-17-00 check the CTIS register for the current data. * To evaluate whether continuous secukinumab treatment is superior to placebo in preventing flares during Treatment Period 2 in…

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Apremilast (CC-10004) in Pediatric Subjects from 6 through 17 Years of Age with Moderate to Severe Plaque Psoriasis

Primary ObjectiveThe primary objective of the study is to evaluate the clinical efficacy of apremilastcompared with placebo in children and adolescents (ages 6 through 17 years) withmoderate to severe plaque psoriasis.Secondary Objectives- * To…

Prediction aided tapering in reumatoid arthritis patients treated with biologicals

To assess the effect of adding a tapering decision aid on a dynamic flare prediction model to disease-activity-guided dose optimisation (DGDO) on the incidence of flares and medication use.

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults with Generalized Myasthenia Gravis.

This study has been transitioned to CTIS with ID 2023-508284-77-00 check the CTIS register for the current data. The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of gMG in adults with autoantibodies…

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS

Objective(s): Primary objective:The primary objective is to demonstrate the efficacy of bimekizumab administered subcutaneously (sc) every 4 weeks (Q4W) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).…

Clinical effectiveness of 2 treat to target strategies, mimicking standard care compared to early secukinumab for the treatment of Moderate to Severe Psoriatic arthritis: a parallel group randomised controlled trial.

Primary Objective: To compare the effectiveness of the administration of secukinumab to standard care in newly diagnosed Psoriatic Arthritis patients on the ACR50 response at 6 months. Secondary Objectives: To compare effectiveness at 6 and 12…

A PHASE I, RANDOMIZED, DOUBLE BLINDED, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE AND MULTIPLE ASCENDING DOSES OF ORAL GDC-8264 AND THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF GDC-8264 IN HEALTHY VOLUNTEERS

The purpose of this study is to investigate how safe the new compound GDC-8264 is and how well it is tolerated when it is administered to healthy volunteers. GDC-8264 has not been administered to humans before. It has been previously tested in the…

Adalimumab dose reduction aiming low serum concentration with control of disease activity (ADDORA-LOW) : a single blind, non-inferiority, randomised clinical trial

Primary objective: to evaluate the disease activity after dose reduction, aiming adalimumab concentration of 2 mg/L or 5 mg/L, in rheumatoid arthritis patients responding to adalimumab.Secondary objectives: to evaluate whether reducing adalimumab…

A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia

Primary Objective:- To evaluate the efficacy of efgartigimod compared to placebo in achieving a sustained platelet count response in patients with chronic primary immune thrombocytopenia (ITP), with a sustained platelet count response defined as…

New Clinical End-points in patients with primary Sjögren*s Syndrome: an Interventional Trial based on stratifYing patients

This study has been transitioned to CTIS with ID 2023-510054-16-00 check the CTIS register for the current data. Primary objective:To evaluate the efficacy of each active treatment combination (hydroxychloroquine + leflunomide and hydroxychloroquine…

The ENDURRANCE-1 Study. ;Exploring durable remission with rituximab in ANCA associated vasculitis

This study has been transitioned to CTIS with ID 2023-507868-39-00 check the CTIS register for the current data. In this randomized study the primary objective is to demonstrate a clinical significant reduction of RTX retreatments in AAV patients…

Effectiveness and cost-effectiveness of monitoring spondyloarthritis with the integrated eHealth system SpA-Net: a randomized controlled trial

Primary Objective: to determine whether telemonitoring through SpA-Net, in combination with patient-initiated care, leads to less outpatient visits compared with standard care. Secondary Objective(s): to determine whether telemonitoring through SpA-…

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet*s Disease (BEAN)

The main objective of study 20190530 is to estimate the efficacy of Apremilast compared to placebo in the treatment of oral ulcers in pediatric subjects from 2 to < 18 years of age with oral ulcers associated with BD through week 12. See…

A randomized, double-blind, placebo-controlled clinical trial of once-daily inhaled molgramostim nebulizer solution in adult subjects with autoimmune pulmonary alveolar proteinosis (aPAP).

The main objective of this trial is to investigate the efficacy of inhaled molgramostim compared to placebo.