steroid treatment-resistant pemphigus
Conditions
Interventions
Rituximab (genetic recombination)
Sponsors
Department of Dermatology, Keio University School of Medicine
HOKKAIDO UNIVERSITY HOSPITAL OKAYAMA UNIVERSITY HOSPITAL KURUME UNIVERSITY HOSPITAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who were definitively diagnosed of pemphigus during receive PSL with/without "minimal immunosuppressive adjuvant as necessary" (refer to Table 6 1) and experienced disease relapse and a re-increase in the PDAI score during the course of PSL tapering after remission induction. (However, this is limited to the PDAI score at the time of obtaining consent was 1 point or higher and less than 50 points). 2. Patients who receive standard-of-care PSL consisting of 15-30 mg/day. 3. Patients who have persistent or worse PDAI score at two consecutive points at an interval of at least 7 days during a screening period (allowable variation range: PDAI score within 3 times and a difference of +20 points from the time of tentative registration). 4. Male or female aged from 20 to 80 years 5. Patients who are able to be hospitalized for 3 days (2 night) from the date of the initial administration of IDEC-C2B8 (inpatient or outpatient treatment is possible for second administration). 6. Patients in whom the stable dose of PSL for at least 30 days prior to screening. 7. Patients who signed informed consent form.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients who achieve remission (complete remission + partial remission) at Week 25 | — |
Secondary
| Measure | Time frame |
|---|---|
| >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 | — |
Countries
Japan
Contacts
Public ContactYasuko Saito
Keio University Hospital Clinical and Translational Research Center
Outcome results
None listed