Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

• Register: ChiCTR
• Last refreshed on: 27 August 2019
• Main ID: ChiCTR1900025376
• Date of registration: 2019-08-25
• Prospective Registration: Yes
• Primary sponsor: Chinese Academy of Medical Sciences Peking Union Medical College Hospital
• Public title: Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
• Scientific title: Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial
• Date of first enrolment: 2019-09-01
• Target sample size: intervention group:15;control group:15;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=42435
• Study type: Interventional study
• Study design: Parallel
• Phase: 4

Countries of recruitment

China

Contacts

• Name: Mengtao Li
• Affiliation: Chinese Academy of Medical Sciences Peking Union Medical College Hospital

• Name: Yiduo Sun
• Affiliation: Chinese Academy of Medical Sciences Peking Union Medical College Hospital

Key inclusion & exclusion criteria

Inclusion criteria: (1) Aged 18 to 70 years.
(2) Subjects have been diagnosed as SLE according to 1997 ARA classification criteria or 2012 SLICC classification criteria. Skin involvement have been confirmed as Resvised skin lupus erythematosus disease area and severity index (RCLASI) >= 4. Other manifestations have been stable >= 3 months.
(3) Subjects have failed the traditional treatment regimen of 3-month hydroxychloroquine (200-400 mg / day) .
(4) The dose of corticosteroids have been below 30mg/d.Pred for at least 1 month. Treatmenet of HCQ and immunosuppressant (excluding cyclophosphamide) remained stable for at least 3 months.
(5) Written informed consent.
Exclusion criteria: (1) High disease activity with vital organ involvement: severe thrombocytopenia (PLT < 50*10^9/L), hemolytic anemia, active lupus nephritis (haematuria with urinary RBC > 80cell/ul or proteinuria with 24-hour urine protein > 0.5g, newly onset or progressively deteriorate in the nearest 2 weeks), neuropsychiatric lupus, cardiopulmonary involvement (alveolar hemorrhage, pulmonary hypertension, myocardial), gastrointestinal involvement (pseudo-intestinal obstruction).
(2) Severe comorbidities: heart failure (NYHA III~IV ), respiratory failure, renal insufficiency (creatinine clearance <= 30ml / min), liver dysfunction (ALS or AST >= 2 times the upper limit of the normal range), myelosuppression (WBC<3.0*10^9/L or Neut<1.5*10^9/L), peripheral neuropathy.
(3) Acute severe infections: sepsis and cellulitis, hepatitis B or C virus infection during viral replication, M. tuberculosis infection, and human immunodeficiency virus (HIV).
(4) Hypercoagulable state or thrombophilia: hereditary or acquired thrombophilia, history of malignant tumors; history of arterial/venous thrombosis.
(5) History of the following drug treatments within 1 month prior to enrollment: high-dose corticosteroids (=1.0 mg/kg/d.pred), or biological agents, or cyclophosphamide, or intravenous immunoglobulin G (IVIG).
(6) Patients who are pregnant, could be pregnant, or plan to get pregnant (rule out by urine HCG test paper and medical history).
(7) Patients who are allergic to thalidomide or have experienced severe adverse reactions with thalidomide, such as peripheral neuropathy and deep vein thrombosis.

Age minimum: 18
Age maximum: 70
Gender: Both

Health Condition(s) or Problem(s) studied

systemic lupus erythematosus

Intervention(s)

intervention group:lenalidomide 10mg qd;control group:placebo 10mg qd;

Primary Outcome(s)

RCLASI;SLEDAI;

Secondary Outcome(s)

DLQI;PGA;

Source(s) of Monetary Support

National 13th Five-Year Key R&D Program Precision Medicine Project: Clinical and prognostic cohort study of systemic lupus erythematosus (2017YFC0907602)

Ethics review

Status: Approved
Approval date: 05/08/2019
Contact:

[e-mail]

Hui Xu

[phone]

[e-mail]