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GRAVITAS-301: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft Versus Host Disease

Primary objective: Compare the efficacy of itacitinib in combination with corticosteroids versus placebo in combination with corticosteroids in terms of overall response rate (ORR) at Day 28 in subjects with aGVHD.Secondary objectives:- Compare the…

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.

Second IVIg Dose in GBS patients with poor prognosis (SID-GBS trial)

To determine whether a second IVIg course in GBS patients with a poor prognosis improves functional outcome after 4 weeks.

A Phase 4, Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction with Surgery in Subjects with Moderate to Severe Hidradenitis Suppurativa

Primary objective:Assess the safety and efficacy of adalimumab prior to surgery in subjects with moderate to severe HS who are surgical candidates.Secondary objectives:Assess the impact of adalimumab on the planned HS surgical site before surgery,…

The Clinical Efficacy And Subclinical Effects on arterial STIFFNESS of bosentan therapy added to usual care in patients with systemic sclerosis with digital ulcers.

To investigate whether bosentan added to usual care improves arterial stiffness after 3 months as measured as the pulse wave velocity (PWV) of the medium and large arteries corrected for blood pressure changes in patients with SSc with digital…

Optimizing DMARD therapy for primary Sjogren's Syndrome - Leflunomide and Hydroxychloroquine combination therapy for patients with primary Sjogren's Syndrome

In a clinical trial it will be investigated to what extent combination therapy with LEF and HCQ will 1) inhibit disease activity, in particular improvement of ESSDAI and dryness and 2) inhibit activity of (autoreactive) B-cells, T-cells and pDCs. In…

A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis

Primary objective: To assess efficacy and safety (treatment of signs and symptoms) of Nanocort in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation in comparison to a standard of care medication (Depo-Medrol).…

EMDR treatment for anxiety related to the future in MS patients

The objective of this study is to examine whether EMDR with flashforward targets can be effective in reducing anxiety related to the future in MS patients. Specifically, following hypotheses will be examined: EMDR with flashforward target…

A study to characterize the humoral and cellular response following simultaneous immunization with a neo-antigen (KLH) and a recall antigen (tetanus) in healthy volunteers

Investigation of the immune response following immunization with Immucothel/Alhydrogel with or without tetanus. Per efficacy endpoint, the following parameters will be explored:(a) Response size;(b) Inter-individual variability of the response;(c)…

Performance of the HandScan in tight control treatment of Rheumatoid Arthritis

Primary: to compare improvement on the Health Assessment Questionnaire (HAQ) between HandScan guided tight control and treat-to-target treatment and the conventional ACR/EULAR remission guided tight control and treat-to-target treatment of RA after…

RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization

To assess the difference in efficacy between two ultra-low doses (1 x 500 mg and 1 x 200 mg) and standard low dose (1 x 1000 mg) of RTX retreatment on the change in DAS28-CRP, compared to a pre-specified non-inferiority margin of 0.6, at 3 and 6…

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…

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 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 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…

Treatment of thromBocytopenia with EltRombopag or Intravenous Immune Globulin (IVIG) Before and DurING Invasive Procedures in Patients with Immune ThrombocytoPenia.

To compare the effect of eltrombopag and IVIG on the achievement of the platelet count threshold before and after surgery.