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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5mg lenalidomide group | Experimental | 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) |
|
| 10 mg lenalidomide group | Experimental | Lenalidomide 10mg/ day combined with prednisone, the initial dose of prednisone was 0.6-0.8mg/kg/ day for 2-4 weeks, then 5mg every 1-2 weeks until withdrawal (within 24 weeks). |
|
| Prednisone monotherapy group | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate at 52 weeks | "From enrollment to the end of treatment at 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response rate | At 4, 12, 24, 36, 52 weeks | |
| IgG4 - RD RI change | At 4, 12, 24, 36, 52 weeks | |
| Change of IgG4-RD damage index (DI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Beijing, Beijing 100050 | Recruiting | Beijing | China |
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| 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). |
|
| At 4, 12, 24, 36, 52 weeks |
| physician's overall assessment of disease activity | At 4, 12, 24, 36, 52 weeks |
| Changes of serum IgG4 levels | At 4, 12, 24, 36, 52 weeks |
| security | Use CTCAE V5.0 to record adverse events | At 4, 12, 24, 36, 52 weeks |
| ID | Term |
|---|---|
| D000077733 | Immunoglobulin G4-Related Disease |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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