Actively Recruiting
A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-related Disease
Led by Peking Union Medical College Hospital · Updated on 2025-12-30
198
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
For patients with active proliferative IgG4-RD, we plan to conduct a 52-week prospective randomized controlled trial to compare the efficacy and safety of 5mg lenalidomide plus prednisone, 10mg lenalidomide plus prednisone, and prednisone alone, so as to find new treatment measures for patients with proliferative IgG4-RD.
CONDITIONS
Official Title
A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-related Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years
- Meet the 2019 ACR/EULAR classification criteria for IgG4-related disease
- Have active disease with IgG4-RD Response Index (RI) of at least 2 points for initial treatment or relapse after drug withdrawal
- Have active disease with IgG4-RD RI of at least 3 points if relapse occurs while on treatment
- Have the clinical subtype of proliferative IgG4-RD
- Have no plans for pregnancy within 18 months and agree to use reliable contraception during the study
You will not qualify if you...
- Only fibrotic features of IgG4-RD
- Absolute neutrophil count below 1.5 x 10^9/L or platelet count below 100 x 10^9/L
- Creatinine clearance less than 60 ml/min
- Liver function at Child-Pugh grade B or above
- Chronic active infection requiring systemic treatment
- History of malignant tumor within past five years
- History of thrombosis
- Use of biological agents within the past six months
- Known allergy to lenalidomide or thalidomide
- Pregnant or breastfeeding
- Any other medical conditions or investigator judgment making participation unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital, Beijing, Beijing 100050
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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