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Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita.

Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita. - Rtx-BD Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004428
Enrollment
20
Registered
2010-11-01
Start date
2010-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pemphigus, bullous pemphigoid, epidermolysis bullosa acquisita

Interventions

Rituximab

Sponsors

Research group of rare intractable dermatologial disorder
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)PDAI over 10 at first and also PDAI 10 to 15 after treatment of PSL 1.0 mg/kg/day 2weeks. Patients who cannot be into complete remmision by usual treatment. 2) Over 20 years old 3) Patients who can be hospitalized 28 days.

Exclusion criteria

Exclusion criteria: Health condition 1) Pregnancy 2) Allergy for biologics 3) Severe organ disorder 4) History of other diseases which need systemic steroid treatment 5) Infections 6) Malignancy Treatment history 1) Use of biologics 2) Severe adverse events by immunosuppressant (CTCAE over grade 3)

Design outcomes

Primary

MeasureTime frame
1) A rate of severe adverse events, beyond CTCAE grade 3. 2) A rate of remission

Countries

Japan

Contacts

Public ContactJulia Miyamoto

Keio University School of Medicine Dermatology

julia19780124@gmail.com03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026