IgG4-Related Disease Anti-CD19 monoclonal antibody
Conditions
Interventions
None listed
Sponsors
Nagato Kazuo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible for inclusion if they meet all of the following criteria: > Patients who have received sufficient explanation regarding participation in this study and have provided written informed consent. > Patients diagnosed with IgG4 RD as 'definite' or 'probable' according to the comprehensive diagnostic criteria or organ-specific diagnostic criteria in effect at the time of consent. > Patients who, at the time of consent, are scheduled to initiate treatment with inebilizumab (Uplizna IV infusion 100 mg) at a medical institution in Japan. > Patients aged 18 years or older at the time of consent. > Patients who have available medical records during at least the 52 weeks prior to initiation of inebilizumab, or, if disease onset occurred within 52 weeks prior to enrollment, patients who possess some form of medical record from the time of onset onward.
Exclusion criteria
Exclusion criteria: Patients are excluded if they meet any of the following criteria: > Patients who lack the capacity to provide informed consent. > Patients who fall under the contraindications for inebilizumab. > Patients who have received B-cell-depleting therapy within the 6 months prior to the enrollment date, or who have received molecular targeted agents other than inebilizumab (excluding administration of inebilizumab in patients who have completed the OLP of the MITIGATE trial). > Patients whom the investigator determines to be otherwise unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants who experience an adjudicated clinical flare of IgG4-RD at Week 52 after receiving the first inebilizumab treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints at Week 52 > Proportion of participants achieving complete remission (CR) without clinical flare and without requiring additional IgG4-RD-targeted therapies. > Proportion of participants achieving CR without clinical flare and without the use of glucocorticoids. Long-term Evaluations (From first dose to end of observation) > Time to first clinical flare. > Annualized clinical flare rate (ACFR) calculated as the number of adjudicated flares per patient-year. > Treatment initiation for disease activity, and proportion of participants requiring new or escalated treatment (medication or intervention) for new or worsening IgG4-RD symptoms, regardless of Adjudication Committee (DSMB) flare determination, and time to initiation of such treatments. > Cumulative glucocorticoid dose administered for the management of IgG4-RD throughout the study period. | — |
Contacts
Public ContactKazuo Nagato
Tanabe Pharma Corporation
Outcome results
None listed