Autoimmune Diseases Clinical Trial
Official title:
Prospective Multicenter Observational Cohort Study of Comparative Effectiveness of Disease-modifying Treatments for Myasthenia Gravis
This study is designed to address the evidence gaps in a real-world setting and help patients with MG choose treatments that are best suited to them. It is a prospective, multicenter observational cohort study of comparative effectiveness of MG treatments, with a patient-centered primary outcome measure, to guide clinicians, patients and payers regarding the choice of treatment options for this chronic and serious disease. Primary: To compare the effectiveness of azathioprine (AZT) and mycophenolate mofetil (MMF). Secondary: To compare the outcomes in patients receiving an adequate dose and duration of AZT or MMF over the 2-3 year study period, vs. patients not receiving adequate doses and duration of these agents
Design & procedures - This is an observational study in the real world clinical setting to evaluate immunosuppressive treatment (IS) of myasthenia gravis (MG). Patients with acquired autoimmune MG ≥ 18 years of age who are not on IS agents, and have not been on corticosteroids for at least 30 days will be enrolled at 20 sites in the US and Canada. These patients will be treated according to the physician's judgment and patient preferences as in routine clinical practice. Patients will be followed prospectively, with the frequency of clinical visits and laboratory monitoring determined by the treating physician, which may differ among patients. Standard outcome measures measuring efficacy and adverse effects that are used in clinical practice will be collected, with emphasis on patient reported outcomes. Informed consent will be obtained using an approved consent form. Patient identifiable / clinical information from the medical record, including the study outcome measures will be uploaded to a centralized REDCap database. The investigators plan to recruit 220 patients, adjusting for a 10% drop out rate, with a final sample of 200 patients for analysis. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04078698 -
Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine
|
N/A | |
| Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A | |
| Recruiting |
NCT05670301 -
Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases
|
N/A | |
| Completed |
NCT03266172 -
A Study to Compare the Pharmacokinetics (PK) of GSK2982772 Following Administration of Different Modified Release (MR) Formulations in Capsule and MR Tablet Formulations Relative to an Immediate Release (IR) Tablet Formulation and to Check the PK of MR Formulation in Capsule Following Repeat Doses
|
Phase 1 | |
| Completed |
NCT03649412 -
A Study to Investigate the Pharmacokinetics (PK) of Modified Release (MR) Prototype Coated Tablet Formulations of GSK2982772
|
Phase 1 | |
| Recruiting |
NCT04561557 -
Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System
|
Early Phase 1 | |
| Completed |
NCT03173144 -
Chronic Inflammatory Disease, Lifestyle and Treatment Response
|
||
| Completed |
NCT00975936 -
Phase 0 Microdose Study
|
Phase 1 | |
| Not yet recruiting |
NCT05969821 -
Clonal Hematopoiesis of Immunological Significance
|
||
| Completed |
NCT01210716 -
Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
|
Phase 3 | |
| Completed |
NCT00820469 -
Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab
|
Phase 4 | |
| Completed |
NCT01953523 -
Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions
|
N/A | |
| Withdrawn |
NCT03239600 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS)
|
Phase 2 | |
| Completed |
NCT04872257 -
Oral Vitamin D Supplementation Combined With Phototherapy as a Treatment for Vitiligo
|
N/A | |
| Recruiting |
NCT06019611 -
Epidural Stimulation in Multiple Sclerosis
|
N/A | |
| Recruiting |
NCT05030779 -
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus Erythematosus
|
Early Phase 1 | |
| Not yet recruiting |
NCT03899298 -
Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions
|
Phase 1 | |
| Completed |
NCT04005456 -
Personalized Lifestyle Intervention for Improving Functional Health Outcomes Using N-of-1 Tent-Umbrella-Bucket Design
|
N/A | |
| Recruiting |
NCT05085444 -
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
|
Early Phase 1 | |
| Recruiting |
NCT05853835 -
First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641
|
Phase 1 |