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Tests treatment safety and results for IgG4 Related Disease
Official title A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-related Disease
ClinicalTrials.gov ID: NCT07068165
What this study is testing
What is 5mg lenalidomide?
5mg lenalidomide is an investigational medicine, being studied as a potential treatment for igg4 related disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients aged between 18 and 75 years who meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR)...
- Patients with active disease: For patients with initial treatment or relapse after drug withdrawal, active disease is defined as having an IgG4-RD...
- 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；
You likely can't join if
- 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;
See the full eligibility 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...
- 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；
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.