Belimumab Treatment for IgG4-related Disease
-
- STATUS
- Recruiting
-
- End date
- Dec 27, 2023
-
- participants needed
- 60
-
- sponsor
- Peking Union Medical College Hospital
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.
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.
Details
| Condition | igg4 related disease |
|---|---|
| Treatment | prednisone, Prednisone and Belimumab |
| Clinical Study Identifier | NCT04660565 |
| Sponsor | Peking Union Medical College Hospital |
| Last Modified on | 27 January 2021 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer