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A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-related Disease

ConditionIgG4 Related Disease
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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；

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 5mg lenalidomide

    Drug

    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)

  • 10mg lenalidomide

    Drug

    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)

  • Prednisone monotherapy

    Drug

    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).

Treatment groups

198 Participants
are divided into 3 treatment groups
Group A: 5mg lenalidomide groupExperimental treatment 1 intervention
Group B: 10 mg lenalidomide groupExperimental treatment 1 intervention
Group C: Prednisone monotherapy groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recurrence rate at 52 weeks

Time frame
"From enrollment to the end of treatment at 52 weeks

Secondary outcomes

1

Treatment response rate

Time frame
At 4, 12, 24, 36, 52 weeks
2

IgG4 - RD RI change

Time frame
At 4, 12, 24, 36, 52 weeks
3

Change of IgG4-RD damage index (DI)

Time frame
At 4, 12, 24, 36, 52 weeks
4

physician's overall assessment of disease activity

Time frame
At 4, 12, 24, 36, 52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov
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