2023-510054-16-00招募中2 期
NECESSITY – « New Clinical End-points in patients with primary Sjögren’s Syndrome: an Interventional Trial based on stratifYing patients »
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 235
- 试验地点
- 24
- 主要终点
- Proportion of patients achieving a response according to preliminary STAR at week 24 between each active treatment arm and placebo arm. • Cohort 2: Proportion of patients achieving a response according to preliminary STAR at week 24 between each active treatment arm and placebo arm.
研究概览
简要总结
To evaluate the efficacy of each active treatment combination (hydroxychloroquine + leflunomide and hydroxychloroquine + mycophenolate mofetil) based on proportion of responder patients according to preliminary STAR at week 24 in the pooled cohorts
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Cohort 1 : Having given written informed consent prior to undertaking any study-related procedures
- •Cohort 2 : Use highly reliable contraception during study treatment from the screening and for two years after stopping treatment
- •Cohort 1 : Patients with pSS according to ACR/EULAR 2016 criteria or AECG 2002 criteria
- •Cohort 1 : With a high level of symptoms (ESSPRI ≥ 5) and low systemic disease activity
- •Cohort 1 : Negative pregnancy test (serum at screening)
- •Cohort 1 : Use highly reliable contraception during study treatment from the screening and for two years after stopping treatment
- •Cohort 2 : Having given written informed consent prior to undertaking any study-related procedures
- •Cohort 2 : Patients with pSS according to ACR/EULAR 2016 criteria or AECG 2002 criteria
- •Cohort 2 : With moderate/high systemic disease activity, as defined by ESSDAI ≥ 5
- •Cohort 2 : Negative pregnancy test (serum at screening)
排除标准
- •Age < 18 years
- •Previous treatment with HCQ, LEF, or MMF in the last 3 months
- •Previous treatment with rituximab, other B-cell targeted biologic therapy or cyclophosphamide in the last 6 months
- •Previous treatment with anti-TNF, abatacept, tocilizumab or belimumab or any other biologic in the setting of a past clinical trial in the last 3 months
- •Severe life-threatening systemic involvement requiring cyclophosphamide or high-dose corticosteroids, or any drug considered as an exclusion criteria
- •Impairment of other severe immunodeficiency states
- •Patients with active malignancy or history of malignancy within the last 5 years except non-melanoma skin cancer
- •Patients with active gastrointestinal tract ulceration, hemorrhage and perforation
- •Patients with history of cardiomyopathy
- •Patients with known hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome
- •Serious infection in the past month
- •Pregnant or breastfeeding women or women wanting to conceive either during or within two years after the end of the treatment period
- •Evidence of active tuberculosis infection
- •Active HCV (positive PCR)
- •Active HBV infection (positivity for HBS antigen, or positivity for anti-HBC antibody without any HBS antigen)
- •HIV infection (positive serology)
- •Positive SARS-Cov2 PCR (if vaccinated for COVID-19, no PCR is required; if history of COVID-19 infection, positive serology is sufficient)
- •Cytopenia defined as neutrophils < 1.0 G/L, lymphocytes < 0.5 G/L, Hb < 10 g/dl or platelets < 100 G/L
- •Moderate to severe renal insufficiency (GFR < 30 ml/min)
- •Severe hypogammaglobulinemia defined as gamma globulins or IgG < 5 g/l
- •Reduced hepatic function: AST or ALT > 2x ULN
- •Prolonged ECG's corrected QT interval (>500 ms)
- •Women of childbearing potential not using highly effective methods of contraception
- •Known history of maculopathy
- •Patients not informed of the risk of alcohol consumption and of the recommendations to avoid alcohol during the entire study
- •Not affiliated to a social security regime (specific for France)
- •Participation in another interventional trial
- •Contra-indication to HCQ: pre-existing retinopathy, hypersensitivity to HCQ or to any of the excipients of the specialty used
- •Contra-indication to MMF: hypersensitivity to mycophenolate mofetil, acid mycophenolic, mycophenolate sodium or to any of the excipients of the specialty used
- •Contra-indication tor LEF: hypersensitivity to the active substance, the main active metabolite teriflunomide or to any excipients of the specialty used
- •Concomitant treatment with corticosteroids more than 10 mg/day of prednisone equivalent at screening or inclusion (randomisation)
- •Concomitant treatment with other immunomodulators including methotrexate, azathioprine, cyclophosphamide, cyclosporine and tacrolimus
结局指标
主要结局
Proportion of patients achieving a response according to preliminary STAR at week 24 between each active treatment arm and placebo arm. • Cohort 2: Proportion of patients achieving a response according to preliminary STAR at week 24 between each active treatment arm and placebo arm.
Proportion of patients achieving a response according to preliminary STAR at week 24 between each active treatment arm and placebo arm. • Cohort 2: Proportion of patients achieving a response according to preliminary STAR at week 24 between each active treatment arm and placebo arm.
次要结局
未报告次要终点
研究者
Coordinator Investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (24)
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