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Efficacy of AlbenDazole to inDuce mUcosal healing in Patients on anti-TNF monotherapy: ADD UP trial

To evaluate the safety and efficacy of 12 weeks albendazole treatment added to anti-TNF monotherapy in adult patients with Crohn*s disease with incomplete mucosal healing.

(Methyl)prednisolone and diazoxide in type 1 diabetes at onset

To examine the effects and safety of methylprednisolone combined with diazoxide on the progression of type 1 diabetes at the onset of disease

TREAT EARLY ARTHRALGIA TO REVERSE OR LIMIT IMPENDING EXACERBATION TO RHEUMATOID ARTHRITIS

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A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Orelvo (voclosporin) (23.7 mg Twice Daily) with Placebo in Achieving Renal Response in Subjects with Active Lupus Nephritis

Main objective:To assess the efficacy of Orelvo (voclosporin) compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis (LN)Secondary objective:To assess the safety and tolerability of Orelvo…

A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

To evaluate the long-term safety and tolerability of elsubrutinib and upadacitinib given alone or as the ABBV-599 (elsubrutinib/upadacitinib) combination in SLE subjects who have completed the M19-130 Phase 2 study.

A single ascending dose trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of orally administered AS-0871 in healthy subjects

The primary objective is to investigate the safety and tolerability of AS-0871 following single-dose oral administration in healthy subjects.The secondary objectives are:To investigate the PK of AS-0871 (in plasma) following single-dose oral…

A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis

Primary Objective:The primary objective is to demonstrate the efficacy of 1 or 2 dose regimens of HZN-825 versus placebo in subjects with diffuse cutaneous SSc, as determined by a comparison of change in forced vital capacity (FVC) % predicted after…

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects with Moderate to Severe Hidradenitis Supperativa.

The objective of this study is to assess the safety and efficacy of 2 dose levels of risankizumab versus placebo for the treatment of signs and symptoms of moderate to severe Hidradentitis Supperativa in adult subjects diagnosed for at least one…

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 Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus

The main objective of this study is to evaluate the safety and efficacy of ABBV-105, upadacitinib, and ABBV-599 versus placebo for the treatment of signs and symptoms of SLE in participants with moderately to severely active SLE and to define doses…

Timing of umbilical cord clamping during an elective caesarean delivery and its association with neonatal gut microbiome

Primary Objective: To compare the composition and functionality of neonatal microbiome arising from mothers receiving antibiotic prophylaxis before skin incision with the microbiome of neonates born when antibiotics are given after umbilical cord…

\u201cA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in Adult Subjects with Active Lupus Nephritis\u201d (protocol HGS1006-C1121)

* To evaluate the efficacy of belimumab in combination with standard of care in adult subjects with lupus nephritis Class III, IV, or V using the 2003 ISN/RPS criteria. * To assess the safety and tolerability of belimumab plus standard of care…

Adalimumab dose optimisation in rheumatoid arthritis using therapeutic drug monitoring (ADDORA): multi-centre open label randomised controlled trail

The main objective is to evaluate whether adalimumab dose reduction using adalimumab serum measurements (TDM strategy) will minimize medical costs, compared to disease activity guided dose reduction in rheumatoid arthritis (RA) patients.

Methotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response

The main goal of the proposed project is to compare two MTX dosing regimens to suppress ADA levels in patients with inflammatory bowel disease (IBD) with loss of response to anti-TNF agents, and to relate these findings to clinical and biochemical…

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy,
Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle
Weakness.

Primary Objective:- Efficacy of ARGX-113 as assessed by the percentage of "Myasthenia Gravis Activities of Daily Living (MG-ADL) responders" in the acetylcholine receptor (AChR)- antibody (Ab) seropositive population.Secondary Objectives:1…

A randomized, adaptive, investigator/subject blind, single ascending dose, placebo-controlled phase I study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered RO7049665 in healthy volunteers.

The purpose of the study is to investigate to what extent RO7049665 is tolerated. It will also be investigated how quickly and to what extent RO7049665 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the…

A Phase-IV, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of Golimumab (MK-8259 [SCH 900259]) After Treatment Withdrawal, Compared With Continued Treatment (Either Full- or Reduced-Treatment Regimen), In Subjects With Non-Radiographic Axial Spondyloarthritis

Primary objectives and hypotises: In adults with active nr-axSpA who attain inactive disease after receiving open-label golimumab during a 10-month run-in (Period 1):Primary Objective: To evaluate the effect of treatment withdrawal vs continued…

Mesenchymal stem cells for angiogenesis and neovascularisation in digital ulcers of systemic sclerosis

This study has been transitioned to CTIS with ID 2024-515387-31-00 check the CTIS register for the current data. To investigate whether in patients with peripheral vascular complications related to SSc, intramuscular allogeneic BM-MSC therapy is…

The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis

The purpose of this study is to determine the cost - effectiveness and safety of prednisolone 5 mg / day for 2 years compared with placebo , in patients 65 and older with rheumatoid arthritis .

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) (study 205646)

Primary:To evaluate the efficacy of belimumab and a single cycle of rituximab administered in a combination regimen to adult participants with SLE. Secondary:Other aspects of efficacy. Safety and tolerability. Questionnaires.