EUCTR2018-003877-91-DE进行中（未招募）1 期
Sequential B cell/T cell therapy to re-induce humoral immune tolerance in ACPA-positive Rheumatoid Arthritis (TOLERA): a prospective randomized controlled open-label single-centre clinical trial in adult subjects with active ACPA-positive Rheumatoid Arthritis failing Methotrexate - TOLERA
niversitätsklinikum Erlangen0 个研究点目标入组 20 人开始时间: 2019年2月26日最近更新:
适应症
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
- 20
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
- •Subject must be able to understand and communicate with the investigator and comply with the requirements of the study, must give a written and signed and dated informed consent before any study assessment is performed
- •Male or non-pregnant, non-lactating female subjects at least 18 years of age
- •Able to adhere to the study visits and protocol
- •Satisfy the ACR-EULAR 2010 classification criteria of Rheumatoid Arthritis at time point of diagnosis
- •SDAI > 11 at screening
- •ACPA positive (anti CCP2 antibody compulsory at screening) (+/- rheumatoid factor)
- •Completed vaccination for pneumococcus pneumoniae according to local guidelines at Baseline
- •Inadequate treatment response with highest tolerated dose after 3 months therapy and/or intolerance to cDMARDs specifically Methotrexate, Sulfasalzine, Hydroxychloroquine and Leflonumide or bDMARDs specifically TNF-alpha inhibitors or IL-6 receptor blockers.
- •Subjects who have previously been treated with other DMARDs will be allowed entry into study after appropriate wash-out period prior to baseline:
- •oEtanercept: 4 weeks or longer
- •oInfliximab: 8 weeks or longer
- •oAdalimumab: 10 weeks or longer
- •oGolimumab: 8 weeks or longer
- •oCertolizumab: 8 weeks or longer
- •oTocilizumab: 8 weeks or longer
- •oBaricitinib: 1 week or longer
- •oSecukinumab: 20 weeks or longer
- •For all other DMARDs not mentioned above the wash-out period should be five times the half-life of the DMARD concerned.
- •Sulfasalazin, Hydroxychloroquine and Leflunomide must be stopped during screening phase and be replaced by Methotrexate (if possible).
- •As csDMARD: only simultaneous therapy with Methotrexate allowed if tolerated
- •Maximum Glucocortidoiddose at Baseline: 20mg Prednisolone equivalent daily
- •JC-Virus DNA in Serum negative at screening
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Ongoing or previously treatment with Abatacept or Rituximab
- •Hypersensitivity to the active substance, mouse proteins (Rituximab), chinese hamster ovary cells (Abatacept) or other components
- •Contraindication for Rituximab or Abatacept treatment according to their SmPCs
- •Use of any other biologic immunomodulatory agent (monoclonal antibody) except insulin.
- •Active ongoing inflammatory diseases other than RA that might confound the evaluation of the benefit of the therapy (including SLE, PSS, MCTD, SpA, Behcet disease, vasculitis or autoimmune hepatitis)
- •Active systemic infections during the last two weeks prior to baseline (exception: common cold)
- •History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold test. If presence of latent tuberculosis is established then treatment according to local country guidelines must have been initiated but patient cannot take part in the study.
- •Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
- •Known active or past infection with hepatitis B or hepatitis C at screening or baseline as defined by Antibody positivity and/or positive DNA/RNA levels of hepatitis B/C
- •History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed)
- •Uncontrolled severe concomitant disease (including diabetes with plasma glucose >11.1 mmol/l rsp. 200 mg/dl, heart insufficiency >= NYHA III, COPD with severity >= GOLD 3, asthma according to GINA classification >= step 3)
- •Patients with weakened immune system defined as diagnosis of CVID, HIV and or total IgG levels lower than 600 mg/dl)
- •Requirement for immunization with live vaccine during the study period or within 4 weeks preceding baseline.
- •Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the subject and/or places the subject at unacceptable risk for participation in an immunomodulatory therapy
- •Evidence of severe renal dysfunction defined as eGFR < 30 ml/min/1,73 m2 (calculated using the MDRD formula) at screening (Visit 1)
- •History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST) = 3 fold upper limit of normal (ULN), SGPT (ALT) ) = 3 fold ULN, alkaline phosphatase = 3 fold ULN, or serum bilirubin = 2 fold ULN .
- •Screening total WBC count <3,000/µL, or platelets <100,000/µL or neutrophils <1,500/µL or haemoglobin <8.5 g/dL (85g/L)
- •Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
- •Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
- •Prior history of suicide attempt at any time in the subject's life time prior to screening and baseline, or major psychiatric illness requiring hospital
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