Recruiting NCT07068165
A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-related Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 5mg lenalidomide, 10mg lenalidomide, Prednisone monotherapy.
- Who it may be relevant to
- Registry conditions: IgG4 Related Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-RD
Overview
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.
Interventions
- Drug 5mg lenalidomide
Lenalidomide 5mg/d combined with prednisone, prednisone at an initial dose of 0.6-0.8mg/kg/d for 2-4 weeks, then reduced by 5mg every 1-2 weeks until discontinued (within 24 weeks) - Drug 10mg lenalidomide
Lenalidomide 10mg/ day combined with prednisone, prednisone at an initial dose of 0.6-0.8mg/kg/ day for 2-4 weeks, then reduced by 5mg every 1-2 weeks until discontinued (within 24 weeks) - Drug Prednisone monotherapy
The initial dose of prednisone was 0.6-0.8mg/kg/ day for 2-4 weeks, followed by 5mg every 1-2 weeks until withdrawal (within 24 weeks).
Primary outcome measures
- Recurrence rate at 52 weeks [Time frame: "From enrollment to the end of treatment at 52 weeks]
Secondary outcome measures (6)
- Treatment response rate [Time frame: At 4, 12, 24, 36, 52 weeks]
- IgG4 - RD RI change [Time frame: At 4, 12, 24, 36, 52 weeks]
- Change of IgG4-RD damage index (DI) [Time frame: At 4, 12, 24, 36, 52 weeks]
- physician's overall assessment of disease activity [Time frame: At 4, 12, 24, 36, 52 weeks]
- Changes of serum IgG4 levels [Time frame: At 4, 12, 24, 36, 52 weeks]
- security [Time frame: At 4, 12, 24, 36, 52 weeks]
Eligibility criteria
Inclusion criteria
- 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；
- 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；
- Patients with the clinical subtype of proliferative IgG4-RD；
- 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
- IgG4-RD patients with only fibrotic features;
- Absolute neutrophil count <1.5×10\^9 /L or platelet count <100×10\^9/L;
- Creatinine clearance less than 60 ml/ min;
- Liver function Child-Pugh grade B or above;
- Chronic active infection requiring systemic treatment;
- Diagnosed with malignant tumor in the past five years;
- Patients with a history of thrombosis;
- Using biological agents within six months;
- Known to be allergic to lenalidomide or thalidomide;
- Pregnant or lactating women;
- Patients with any other medical conditions or for specific reasons judged by the investigator to be ineligible to participate in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking Union Medical College Hospital, Beijing, Beijing 100050 — Beijing
Identifiers
NCT: NCT07068165 · I-25PJ0175