NL-OMON55055招募中不适用
ew Clinical End-points in patients with primary Sjögren*s Syndrome: an Interventional Trial based on stratifYing patients - Necessity
Assistance Publique_Hôpitaux de Paris (APHP), by delegation Clinical Research and Innovation Direction (DRCI)0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Having given written informed consent prior to undertaking any study-related
- •procedures.
- •- Patients with pSS according to ACR/EULAR 2016 criteria or AECG 2002 criteria
- •(see addenda 4)
- •- 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 study-related
- •procedures.
- •- Patients with pSS according to ACR/EULAR 2016 criteria or AECG 2002 criteria
- •(see addenda 4)
- •- 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.
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
- •- 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
- •- 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
- 另有 1 项未显示
研究者
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