Clinical efficacy of dupilumab treatment in patients with IgG4-related disease
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0006819
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 5
(1) Among patients over 19 years old who are diagnosed with IgG4-related disease and treated with standard drug (systemic steroid, systemic immunosuppressant), ones who are partially controlled or unable to be controlled using standard drug (2) Ones who are willing to and able to comply with outpatient visits and procedures and surveys related to trial (3) Ones who have provided written consent as mentioned in agreement procedure (4) In case of women of childbearing age, ones who have agreed to use a highly effective contraception method
(1) Ones who have anaphylaxis in his or her medical history (2) Ones who have been administered with biological inhibitors including, but not limited to, dupilumab within 3 months period. (3) Ones who are diagnosed with malignant tumor within 5 years period prior to screening visit. (4) Ones who have comorbid conditions and when those conditions are considered to have negative influence on participation of study subject in clinical study. (5) Women who are pregnant or are breast-feeding or women who are planning on becoming pregnant or breast feeding (6) Based on investigator’s decision, ones who are ineligible to participate due to other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete or partial response (treatment response will be evaluated based on IgG4-RD responder index).
- Secondary Outcome Measures
Name Time Method Complete or partial response (treatment response will be evaluated based on IgG4-RD responder index).;aggravation of disease activity and adverse drug events (treatment response will be evaluated based on IgG4-RD responder index).;reduction in systemic corticosteroids requirement