Open-label, single-arm, multicenter, investigators initiated phase II clinical trial to evaluate the efficacy and safety of IDEC-C2B8 in patients with steroid treatment-resistant pemphigus
- Conditions
- steroid treatment-resistant pemphigus
- Registration Number
- JPRN-UMIN000024265
- Lead Sponsor
- Department of Dermatology, Keio University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1. Women who are nursing, pregnant, intending to be pregnant. 2. Patients with a history of hypersensitivity or shock to humanized or mouse monoclonal antibodies or mouse-derived components. 3. Patients with severe and uncontrollable organ failure. 4. Patients with any concomitant condition that required treatment. 5. Patients with an active infection. 6. Patients who received an infusion of antibiotics or patients with an infectious disease that requires hospitalization. 7. Patients who received an oral administration of antibiotics. 8. Patients with a history of a bacteremia caused by Staphylococcus aureus or Pseudomonas aeruginosa. 9. Patients who experienced bone soft tissue infections or any type of organ abscess. 10. Patients with a history of severe recurrent infection or chronic infection. 11. Patients with a malignant tumor or a history of a malignant tumor. 12. Patients with a history of addiction to alcohol or drugs. 13. Patients with a severe psychiatric disorder. 14. Patients in whom an operative treatment has been performed. 15. Patients with a history of severe infection after starting immunosuppressive agent administration. 16. Patients who previously received administration of anti-CD20 antibody. 17. Patients who have used a live vaccine or attenuated vaccine. 18. Patients in whom the following clinical laboratory abnormalities are noted during the SCR period. 19. Patients who have begun or increased the dose of an oral immunosuppressive agent. 20. Patients who received IVIG. 21. Patients who received intravenous steroid pulse therapy. 22. Patients who received plasmapheresis. 23. Patients who received intravenous cyclophosphamide pulse therapy . 24. Patients treated with other investigational drugs. 25. Patients who are determined as unfit for the enrollment in the study after an investigation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of patients who achieve remission (complete remission + partial remission) at Week 25
- Secondary Outcome Measures
Name Time Method >Pemphigus Disease Area Index (PDAI) values at Week 25 >Changes from baseline in PDAI >Changes from baseline in pemphigus autoantibody values (anti-Dsg1,anti-Dsg3 autoantibodies) >Changes from baseline in CD19+ B-cell counts, CD20+ B-cell counts, and CD3+ T-cell counts Safety endpoints: >Type, frequency, and severity of adverse events >Type, frequency, and severity of adverse drug reactions Other endpoints: >Pharmacokinetic analysis (changes in peripheral blood concentration of IDEC-C2B8) >Expression rate of human anti-IDEC-C2B8 antibody (HACA) >Changes from baseline in immunoglobulin values