UnknownNot Applicable

Treatment Strategies in IgG4-RD Patients With Re-elevation of Serum IgG4 Level During Maintenance Remission Period

China108 participantsStarted 2023-08-01

Plain-language summary

This study has been designed as a 52-week, randomized double blind placebo controlled multicenter clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in IgG4-RD patients with re-elevation of serum IgG4 level during maintenance remission period: basic maintenance treatment group (continue use of basic maintenance treatment of IgG4-RD) and enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD).

Who can participate

Age range18 Years – 70 Years

SexALL

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Exclusion criteria

✕. Patients with adenocarcinoma in situ (AIS) of the cervix who have received curative treatment for at least 12 months before screening.
✕. Patients with cutaneous basal or squamous cell carcinoma who have received curative treatment.
✕. Patients with prostate cancer, who have received radical prostatectomy or definitive radiotherapy for over 3 years, with no sign of relapse or ongoing treatment
✕. Hemoglobin level \< 7.5g/dL.
✕. neutrophil count \< 1.0×10\^9/L.
✕. Platelet count \< 100×10\^9/L.
✕. Alanine aminotransferase (ALT) \> 2 × upper limit number (ULN).
✕. Aspartate aminotransferase (AST) \> 2 × ULN.

What they're measuring

The difference of relapse rate of IgG4-RD between two groups in week 52.

Timeframe: 52 weeks

Trial details

NCT IDNCT05974683

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Jiaxin Zhou, MD

86-10-69155647 pumczhou@sina.com

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