Clinical trials: Autoimmune Disorder
Type 1 Diabetes Mellitus
Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus
This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).
- Trial name
- NCT01742208
- Testing
- Sotagliflozin
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Lexicon Pharmaceuticals
Type 1 Diabetes Mellitus
Pivotal Omnipod Horizon™ Automated Glucose Control System
Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting and…
- Trial name
- NCT04196140
- Testing
- Omnipod Horizon™ Automated Glucose Control System
- Where
- 16 sites in United States
- Volunteers
- 240 people
- Sponsor
- Insulet Corporation
Rheumatoid Arthritis
A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate
This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in…
- Trial name
- NCT01587989
- Testing
- methotrexate, tocilizumab [RoActemra/Actemra]
- Where
- 13 sites in Austria
- Volunteers
- 77 people
- Sponsor
- Hoffmann-La Roche
Type 1 Diabetes Mellitus
Initiation of Continuous Glucose Monitoring at Diagnosis of Type 1 Diabetes
The purpose of this study is to learn about the impact of continuous glucose monitoring (CGM) on families with newly diagnosed children with type 1 diabetes (T1D).
- Trial name
- NCT02734667
- Testing
- CGM at diagnosis of T1D
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- Korey Hood
Diabetes Mellitus Type 1
A Prospective, Randomized, Double-blind, Placebo Controlled Study to Assess the Impact of ORMD-0801 (Insulin Capsules) on the Exogenous Insulin Requirements of Type 1 Diabetics
This will be a prospective, randomized, double-blind, placebo controlled study. Patients with established Type 1 diabetes will be eligible for entry into the study.
- Trial name
- NCT02094534
- Testing
- ORMD-0801 Capsules
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Oramed, Ltd.
Vasculitis, Wegener's Granulomatosis
Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis
Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults.
- Conditions
- Vasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis
- Trial name
- RAVE (NCT00104299)
- Testing
- Azathioprine, Methylprednisolone (or other glucocorticoid), Prednisone
- Where
- 8 sites in United States, Netherlands
- Volunteers
- 197 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Radiologically Isolated Syndrome, Multiple Sclerosis
Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease.
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 4 study in which eligible patients with RADIOLOGICALLY ISOLATED SYNDROME (RIS) (as defined by meeting 2017 McDonald criteria for DIS) will be randomized…
- Trial name
- CELLO (NCT04877457)
- Testing
- Ocrelizumab
- Where
- 4 sites in United States
- Volunteers
- 3 people
- Sponsor
- Yale University
Type 1 Diabetes
Safety and Feasibility Testing of a Smaller Network Version of AIDANET
A randomized 1:1 crossover trial that intends to demonstrate feasibility and safety of the Automated Insulin Delivery as Adaptive NETwork (AIDANET) system run in a new smaller network version, used in full closed loop (FCL) by…
- Trial name
- MiniNET (NCT06633965)
- Testing
- AIDANET
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Marc Breton
Autoimmune Diseases
A PH I Pilot Imaging Study to Evaluate Molecular Imaging Methods in HVs and pSS Pts
This is a pilot imaging study to determine whether molecular imaging with 18^F fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT), 11^C-Methionine (MET) PET/CT, and salivary gland magnetic…
- Trial name
- NCT02899377
- Testing
- 18F-FDG PET/CT Imaging, 11C-MET PET/CT Imaging, MRI Imaging with intravenous contrast with gadoterate meglumine
- Where
- 4 sites in United Kingdom
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Multiple Sclerosis
Integrating Caregiver Support Into MS Care
With loss of mobility in multiple sclerosis (MS) comes an increase in amount and types of caregiver assistance, with a concomitant increase in burden for the caregiver.
- Trial name
- NCT02835677
- Testing
- Behavioral
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- VA Office of Research and Development
Type 1 Diabetes
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
Data suggest that intestinal microbiota might be critically involved both in autoimmunity and in glucose homeostasis. An acetylated and butyrylated form of high amylose maize starch (HAMS-AB) that increases beneficial short chain…
- Trial name
- NCT04114357
- Testing
- Acetylated and Butyrylated High Amylose Maize Starch
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Indiana University
Neuromyelitis Optica Spectrum Disorder, NMOSD
A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention
Objective of the trial is to describe the efficacy and safety of satralizumab in patients with aquaporin-4 (AQP4) antibody seropositive NMOSD, either treatment naive or inadequate responders to previous treatment with rituximab…
- Trial name
- SAkuraBonsai (NCT05269667)
- Testing
- Satralizumab 120 mg
- Where
- 3 sites in United States, South Korea and 1 more
- Volunteers
- 4 people
- Sponsor
- Hoffmann-La Roche
Type 1 Diabetes Mellitus
USS Virginia Closed-Loop Versus SAP Therapy for Hypoglycemia Reduction in T1D
This is a randomized, controlled trial of Unified Safety System (USS) Virginia closed-loop versus sensor-augmented pump (SAP) therapy for hypoglycemia prevention in subjects with type 1 diabetes and hypoglycemia unawareness…
- Trial name
- NCT02302963
- Testing
- AP System (DiAs or inControl) with USS Virginia
- Where
- 2 sites in United States
- Volunteers
- 85 people
- Sponsor
- University of Virginia
Lupus Nephritis
A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)
This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.
- Trial name
- NCT02550652
- Testing
- Mycophenolate Mofetil/Mycophenolic Acid, Obinutuzumab, Methylprednisolone
- Where
- 46 sites in United States, Argentina and 10 more
- Volunteers
- 126 people
- Sponsor
- Hoffmann-La Roche
Ischemic Foot Ulcer
Intensive Insulin Treatment and Ischemic Foot Ulcer
We aim to investigate the relationship between skin microvascular function and the first hospitalization for ischemic foot ulcer in patients with type 1 diabetes former randomized during 7.5 years to intensified conventional…
- Trial name
- NCT01957930
- Testing
- Intensified insulin treatment, Standard treatment
- Where
- 2 sites in Sweden
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Karolinska Institutet
Primary Immune Thrombocytopenia
A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.
- Trial name
- ADVANCE SC (NCT04687072)
- Testing
- Efgartigimod PH20 SC
- Where
- 200 sites in United States, Argentina and 30 more
- Volunteers
- 207 people
- Sponsor
- argenx
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
This is a Phase 1 single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with seropositive SLE or RA.
- Trial name
- NCT03334851
- Testing
- PF-06835375
- Where
- 17 sites in United States
- Volunteers
- 74 people
- Sponsor
- Pfizer
Multiple Sclerosis
Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE
The Departments of Neurology and Neurosurgery are conducting this research study to evaluate the safety and effectiveness of intravascular angioplasty for the treatment of venous narrowing in the treatment of Multiple Sclerosis…
- Trial name
- PREMiSE (NCT01450072)
- Testing
- Selective Venography followed by therapeutic balloon angioplasty, Control arm
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- State University of New York at Buffalo
Rheumatoid Arthritis
To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)
Primary Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.
- Trial name
- NCT01768572
- Testing
- sarilumab SAR153191 (REGN88), tocilizumab, hydroxychloroquine
- Where
- 78 sites in United States, Argentina and 17 more
- Volunteers
- 202 people
- Sponsor
- Sanofi
Type 1 Diabetes
Evaluating the Benefits of Physiologic Insulin Delivery
In normal physiology insulin is secreted by beta cells into the portal vein. There have been a number of purported benefits among long-term intraperitoneal insulin users.
- Trial name
- NCT04416737
- Testing
- Ultra-rapid insulin
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Stanford University
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