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A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis…

A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus
Eltrombopag, in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)

Core StudyPrimary objective• To compare the efficacy of E5501 (in addition to standard of care) to eltrombopag (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic thrombocytopenic…

A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)

Primary Objective is to evaluate the long-term safety of sirukumab in subjects with RA who are refractory to DMARDs or anti-TNF* agents.The secondary objectives are to observe the following long-term effects of sirukumab in subjects with RA who are…

An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2).

Part 1: To assess the safety and effectiveness of subcutaneous golimumab 50 mg (SC-GLM50), administered by autoinjection once monthly during 6 months, when combined with different DMARD regimens used in daily rheumatology. Part 2: In subjects who…

A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.

To assess the efficacy and safety of treatment with tocilizumab versus adalimumab, both in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis who have had an inadequate efficacy response to treatment with…

Joint distraction as a treatment for end stage knee osteoarthritis: a comparison with presently applied surgical alternatives.

1. Is KJD clinically non-inferior to current surgical techniques (HTO and TKP)?2. Is KJD superior to HTO in actual structural repair of cartilage?3. Is KJD cost-effective in the long-term compared to HTO and TKP?

Joint distraction (KJD) in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: high tibial osteotomy (HTO)

1. To compare cartilage repair between KJD and HTO, evaluated 2 years post treatment. The hypothesis is that KJD results in (more) cartilage repair compared to HTO. 2. To compare cartilage tissue repair over 2 year follow-up compared to baseline and…

A Phase IIIB multicentre, randomized, double*blind, double dummy study to compare the efficacy and safety of abatacept administered subcutaneously and intravenously in subjects with rheumatoid arthritis, receiving background methotrexate, and experiencing an inadequate response to methotrexate.

The primary objective for this study is to demonstrate that SC injections of abatacept are non-inferior to IV infusions of abatacept .

A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNF alfa Chimeric Monoclonal Antibody (Infliximab, Remicade) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis.

Primary: To prove that infliximab in combination with azathioprine is superior to azathioprine alone in rapidly inducing a meaningful renal improvement, defined as a reduction in preoteinuria of at least 50%, in patients with membranous SLE…

A Randomized controlled trial comparing two different immunoglobulins in the treatment of CIDP.

To investigate if:-Kiovig is at least as effective as Gammagard. (equivalence)-Kiovig has a good side effect profile for CIDP patients.-Whether patients prefer Kiovig to Gammagard.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

The primary objective of this endpoint study is to evaluate the safety of tofacitinib at two doses versus TNFi; the co-primary endpoints are adjudicated major adverse cardiovascular events (MACE) and adjudicated malignancies excluding non-melanoma…

Protocol I1F-MC-RHBS;A 52-Week Multicenter, Randomized, Blinded, Parallel Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis

The primary objectives of this study are to assess whether 80 mg ixekizumab every 2 weeks (Q2W) is:• noninferior to ustekinumab at Week 12 in the treatment of patients with moderate-to-severe plaque psoriasis as measured by proportion of patients…

A randomized trial to investigate the reset of humoral autoimmunity by combining belimumab with rituximab in severe systemic lupus erythematosus

The primary objective is to assess whether combination treatment BLM+RTX will lead to reduced treatment failure and the improvement of pivotal, SLE-specific autoimmune phenomena compared SLE patients treated with standard of care.

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…

A 52-week, randomized, double-blind, double-dummy, parallel-group, multi-centre, non-inferiority study to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care (SoC) therapy

This study has been transitioned to CTIS with ID 2023-510019-20-00 check the CTIS register for the current data. Primary:To evaluate the efficacy of depemokimab 200 mg SC every 26 weeks compared with mepolizumab 300 mg SC every 4 weeks in…

A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis (gMG)

Primary objective:- To assess the clinical efficacy of efgartigimod IV 10mg/kg administered in a q2w continuous regimen compared to that administered in a cyclic regimen.Secondary objectives:- To evaluate the safety and tolerability of both…

A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib (ABT 494) to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)

Main objective:1. To compare the safety and efficacy of upadacitinib 15 mg once daily (QD) versus abatacept intravenous (IV) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-inadequate response (bDMARD-IR) or bDMARD-…

A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)

Primary• To evaluate the effect of ravulizumab on adjudicated On-Trial Relapses in adult patients with NMOSDSecondary• To evaluate the safety of ravulizumab in adult patients with NMOSD• To evaluate the effect of ravulizumab on adjudicated…

Tacrolimus versus mycophenolate for AutoImmune hepatitis patients with incompLete response On first line therapy: a Randomized trial

The aim of this study is to compare the effectiveness of TAC with MMF as a second line treatment for AIH. Proportion of patients with CR after 12 months of treatment will be the primary outcome parameter to determine effectivity.

A multicenter, randomized, open label, efficacy assessor-blinded study of risankizumab compared to secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systematic therapy.

The objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.