Phase II prospective treatment study for IgG4+MOLPS

UMIN ID: UMIN000002311

Registered date:10/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: IgG4+MOLPS (IgG4+Multiorgan lymphoproliferative syndrome)
• Date of first enrollment: 2009/08/01
• Target sample size: 57
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Initial dose of prednisolone 0.6mg/kg/day. Taper prednisolone every 2 weeks 10%, and maintenance dose 10mg/day at least 3 months.

Outcome(s)

• Primary Outcome: CR rate
• Secondary Outcome: Maintenance dose of steroid, relapse rate, adverse effects

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1, Castleman disease, Wegener granulomatosis, Sarcoidosis, cancer lymphoma, and other distinct disorders. 2, severe infectious disease 3, pre-treatment of steroid or immuno-suppressive drugs 4, physician's decision

Related Information

• Primary Sponsor: Department of Hematology and Immunology, Kanazawa Medical University
• Source(s) of Monetary Support: IgG4+MOLPS research group, Japan