EUCTR2019-002470-32-IT进行中（未招募）1 期
Ew Clinical End-points in patients with primary Sjögren's Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY
ASSITANCE PUBLIQUE DES HOPITAUX DE PARIS0 个研究点目标入组 300 人开始时间: 2022年1月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Having given written informed consent prior to undertaking any studyrelated procedures.
- •- Patients with pSS according to ACR/EULAR 2016 criteria or AECG 2002 criteria
- •- With a high level of symptoms (ESSPRI = 5) and low systemic disease activity (ESSDAI < 5).
- •- Negative pregnancy test (serum at screening)
- •- Use highly reliable contraception (as defined in section 6.3) during research treatment from the screening and for two years after stopping treatment.
- •- Having given written informed consent prior to undertaking any studyrelated procedures.
- •- Patients with pSS according to ACR/EULAR 2016 criteria or AECG 2002 criteria.
- •- With moderate/high systemic disease activity, as defined by ESSDAI = 5.
- •- Negative pregnancy test (serum at screening)
- •- Use highly reliable contraception (as defined in section 6.3) during research treatment from the screening and for two years after stopping treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •For both cohorts:
- •- Age < 18 years
- •- Pregnant or breastfeeding women or women wanted to conceive either during or within two years after the end of the treatment period
- •- Women of childbearing potential not using highly effective methods of contraception (as defined in section 6.3)
- •- 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
- •- Previous treatment with HCQ, LEF, 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 history of 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
- •- 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 (re-testing is allowed, see section 5.10)
- •- Prolonged ECG's corrected QT interval (>500 ms)
- •- Known history of maculopathy
- •- Patients will be informed of the risk of alcohol consumption and will be recommended to avoid alcohol during the entire study
- •- Not affiliated to a social security regime (specific for France)
研究者
相似试验
进行中（未招募）
1 期
Ew Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patientsPrimary Sjögren’s syndrome (pSS)MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2019-002470-32-GRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS ( AP-HP)300
进行中（未招募）
1 期
Ew Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patientsPrimary Sjögren’s syndrome (pSS)MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2019-002470-32-NLASSISTANCE PUBLIQUE - HOPITAUX DE PARIS ( AP-HP)300
进行中（未招募）
1 期
Ew Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patientsEUCTR2019-002470-32-NOASSISTANCE PUBLIQUE - HOPITAUX DE PARIS ( AP-HP)300
招募中
不适用
ew Clinical End-points in patients with primary Sjögren*s Syndrome: an Interventional Trial based on stratifYing patients10003816Sjogren's syndromeNL-OMON55055Assistance Publique_Hôpitaux de Paris (APHP), by delegation Clinical Research and Innovation Direction (DRCI)30
招募中
2 期
New Clinical End-points in Patients With Primary Sjögren's SyndromePrimary Sjögren's Syndrome (pSS)NCT05113004Assistance Publique - Hôpitaux de Paris300