Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04660565
Status:
UNKNOWN
Last Update Posted:
2021-01-08
First Post:
2020-09-23
Brief Title:
Belimumab Treatment for IgG4-related Disease
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Belimumab Treatment for IgG4-related Disease a Prospective Open-label Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Even though glucocorticoid is the current first line medication for IgG4-RD it is well accepted in the field that excessive dosage of GC especially accumulative dosage is associated with increasing organ damage Although B cell depletion with rituximab has been verified to be an effective treatment for IgG4-RD even without concomitant GC therapy rituximab can increase the risk of infection during the treatment Belimumab is an IgG1-lambda monoclonal antibody that prevents the survival of B lymphocytes by blocking the binding of soluble human B lymphocyte stimulator protein BLyS to receptors on B lymphocytes Previous studies and trails suggested that the activity of B-cell mediated immunity and autoimmune responses were ameliorated after belimumab without increasing rates of adverse events when compared to standard of care However the efficacy and tolerability of belimumab in IgG4-RD patients have not been examined before This randomized control clinical trial aimed to evaluate the tolerability and the efficacy of Belimumab for maintenance treatment for IgG4-RD
Detailed Description:
IgG4-RD is associated with substantial morbidity and mortality but there is no established therapy other than GCs for an acute flare Up to date no randomized prospective controlled studies have been performed for this disease and no approved therapy is available Although GCs are widely and effectively used for treatment of initial disease and flare they are associated with substantial toxicity which limits their long-term use Disease flares also occur in many patients either during the GC taper or after GC discontinuation Patients need a treatment that will more effectively control their disease and avoid GC toxicity This study will establish the safety and tolerability of Belimumab in IgG4-RD and its ability to reduce the risk of disease flares There are currently no medicinal products approved for the treatment of IgG4-RD The majority of cases follow a relapsing course that can lead to permanent tissue damage with attendant morbidity and potential mortality Glucocorticoids are widely and effectively used for treatment of initial disease and of flare but they do not prevent recurrence of active disease after their discontinuation and are associated with substantial toxicity Patients also continue to relapse on the off-label steroid-sparing immunosuppressive medications used by some physicians to manage patients with IgG4-RD thus there is a high unmet medical need for more effective therapies in this patient population
The pathogenesis of IgG4-RD suggests that B-cell depletion may be an effective avenue for therapeutic intervention Therapeutic depletion of B cells with rituximab reduces disease-relevant biomarkers and appears to have clinical benefit in uncontrolled retrospective and prospective clinical studies This study aims to define the efficacy and safety of Belimumab for the prevention of flares of this rare disease In addition the potential of Belimumab for minimizing GC exposure could limit the well-known adverse effects of GCs on bone skin muscle adrenal gland and eyes and GC association with weight gain diabetes hypertension and neuropsychiatric effects
The pathogenesis of IgG4-RD suggests that B-cell depletion may be an effective avenue for therapeutic intervention Therapeutic depletion of B cells with rituximab reduces disease-relevant biomarkers and appears to have clinical benefit in uncontrolled retrospective and prospective clinical studies This study aims to define the efficacy and safety of Belimumab for the prevention of flares of this rare disease In addition the potential of Belimumab for minimizing GC exposure could limit the well-known adverse effects of GCs on bone skin muscle adrenal gland and eyes and GC association with weight gain diabetes hypertension and neuropsychiatric effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None