Comparing low- and higher-dose lenalidomide plus prednisone versus prednisone alone for active proliferative IgG4‑related disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2/3, 52-week, single-center randomized controlled trial at Peking Union Medical College Hospital comparing three arms: prednisone alone, prednisone plus 5 mg lenalidomide, and prednisone plus 10 mg lenalidomide. Eligible adults (18–75 years) must meet the 2019 ACR/EULAR criteria for IgG4‑RD and have active proliferative disease by IgG4‑RD Response Index thresholds. The trial will monitor clinical response and safety outcomes, including blood counts and renal function, with regular follow-up visits. The goal is to determine whether adding lenalidomide improves disease control or safety compared with standard prednisone therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged between 18 and 75 years who meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for IgG4-RD；
2. Patients with active disease: For patients with initial treatment or relapse after drug withdrawal, active disease is defined as having an IgG4-RD Response Index (RI) of at least 2 points in at least one organ at the time of screening; for those experiencing relapse while on treatment, active disease is defined as having an IgG4-RD RI of at least 3 points in at least one organ at the time of screening；
3. Patients with the clinical subtype of proliferative IgG4-RD；
4. Patients who have no plans for pregnancy within the next 18 months and who agree to use reliable contraceptive measures during the study period；

Exclusion Criteria:

1. IgG4-RD patients with only fibrotic features;
2. Absolute neutrophil count \<1.5×10\^9 /L or platelet count \<100×10\^9/L;
3. Creatinine clearance less than 60 ml/ min;
4. Liver function Child-Pugh grade B or above;
5. Chronic active infection requiring systemic treatment;
6. Diagnosed with malignant tumor in the past five years;
7. Patients with a history of thrombosis;
8. Using biological agents within six months;
9. Known to be allergic to lenalidomide or thalidomide;
10. Pregnant or lactating women;
11. Patients with any other medical conditions or for specific reasons judged by the investigator to be ineligible to participate in the study.

Where it's running

• Peking Union Medical College Hospital, Beijing, Beijing 100050
  Beijing, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.