Autoimmune Diseases Clinical Trial
Official title:
A Study of Two Different Treatment Strategies in IgG4-related Disease Patients With Re-elevation of Serum IgG4 Level During Maintenance Remission Period: a Randomized Double Blind Placebo Controlled Multicenter Study
This study has been designed as a 52-week, randomized double blind placebo controlled multicenter clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with re-elevation of serum IgG4 level during maintenance remission period: basic maintenance treatment group (continue use of basic maintenance treatment of IgG4-RD) and enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD).
108 IgG4-RD patients with re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4 level during maintenance remission period are to be enrolled in this study after screening period, and then double blind randomly in an 1:1 ratio into two groups: basic maintenance treatment group (continue use of basic maintenance treatment of IgG4-RD plus placebo) and enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD). The follow-up period will be 52 weeks. During the follow-up period, clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded. The primary endpoint is the difference of relapse rate between two groups at 52 weeks. Meanwhile, this study will also explore and study different biomarkers in IgG4-RD patients, to better understand the mechanisms, as well as prognostic factors of IgG4-RD. ;
| 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 |