Exploratory research on effectiveness and safety of Rituximab treatment including maintenance administration for steroid intractable autoimmune bullous diseases of the skin. Rtx-BD Trial (Rituximab of Intractable Autoimmune Bullous Disease Trial) 2

Exploratory research on effectiveness and safety of Rituximab treatment including maintenance administration for steroid intractable autoimmune bullous diseases of the skin. Rtx-BD Trial (Rituximab of Intractable Autoimmune Bullous Disease Trial) 2 - Rtx-BD Trial 2

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015451

Enrollment

Registered

2014-10-25

Start date

2014-11-13

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, Pemphigoid

Interventions

Rituximab 375mg/sqm, q1w, 4 doses. Maintenance administration of rituximab is possible if PDA or BPDAI is between 1 and 10 on week 24 to 48

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who are treated with PSL over 10mg/day and relapsed during steroid taper. 2) Patients who can be hospitalized at least 28 days. If PDAI or BPDAI is under 15, the minimum length of stay in a hospital is 10 days. 3) Patients who have not been treated with high-dose intravenous Ig, plasma exchange, steroid pulse therapy and new immunosuppressant within 30 days before enrollment.

Exclusion criteria

Exclusion criteria: 1) Pregnancy 2) Allergy for biologics 3) Severe organ disorder 4) History of other diseases which need systemic steroid treatment 5) Infections 6) Malignancy

Design outcomes

Primary

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

Countries

Japan

Contacts

Public ContactJun Yamagami

Keio University School of Medicine Depertment of Dermatology

yamagamijun@a8.keio.jp03-3353-1211

Outcome results

None listed

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