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Belimumab Treatment for IgG4-related Disease, a Prospective, Open-label Clinical Trial
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.
Details
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 60 |
| Start date | 2021-01 |
| Completion | 2023-12 |
Conditions
- IgG4-related Disease
Interventions
- Prednisone and Belimumab
- Prednisone
Primary outcomes
- Evaluate the efficacy of Belimumab in reducing the risk of flare in patients with IgG4-RD. — Twelve months
Relapse was defined as the new progress or recurrence of clinical symptoms or imaging findings with or without IgG4 level re-elevation. the new progress or recurrence of imaging findings were evaluated by MRI, CT or Ultrasound. Primary endpoint is the difference of disease relapse rate between two groups. - The difference of time to first flare between two groups; — Twelve months
The date of disease flare is defined as the date of initiation of any flare treatment. The date of disease flare is defined as the date of initiation of any flare treatment (new or increased GC treatment, other immunotherapy, or interventional procedure) deemed necessary by the Investigator for the flare.
Countries
China