CTIS2023-507714-27-00进行中（未招募）1 期
An international, multicentre, interventional, randomised assessor-blinded trial to MAXimise the METHotrexate therapy potential in patients with active rheumatoid arthritis(MethMax trial) - MethMax trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 182
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 65+（—）
- 性别
- All
入选标准
- •Men and women, = 18 years of age, capable of understanding and signing an informed consent (including sufficient literacy and proficiency in the local language) and following the study procedures, Patients with rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria, Ongoing conventional therapy with oral methotrexate (between =10mg and 25mg weekly) for =3 months with stable dosing, and clinical and laboratory tolerance of this treatment for at least 12 weeks, CDAI > 2.8 + at least 1 clinically swollen joint (on 28-Joint count), Willingness to increase methotrexate dosing and change the route of administration according to study procedures
排除标准
- •Inflammatory rheumatic diseases other than RA, Stomatitis under the treatment with MTX, Known history of recurrent/serious infections in the previous two months (such as, but not limited to, Hepatitis, Pneumonia, or Pyelonephritis), A positive HBsAg and/or HCV test at screening visit, Ongoing or recurring opportunistic infections (e.g., Herpes Zoster, Cytomegalovirus, Pneumocystis, Aspergillosis, Histoplasmosis, or Mycobacteria other than TB) as judged by the investigator, Women of childbearing potential without use of adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) and willingness to continue this precaution for the duration of the study until 6 months after receiving the last medication, Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease, as judged by the investigator, Being unable or unwilling to undergo multiple venepunctures because of poor tolerability or lack of sufficient venous access, Being unwilling or unable to perform s.c injections, Presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to screening), Women who are pregnant, nursing; or planning pregnancy during the study and 6 months after the individual study completion, Ongoing or previous therapy with any biological DiseaseModifying Anti-Rheumatic Drug (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) or conventional synthetic DMARDs (csDMARDs) other than methotrexate and hydroxychloroquine, History of alcohol or substance abuse within the preceding 6 months, Any medical or psychological condition that, judged by the investigator, would interfere with safe completion of the trial, Immunization with a live/attenuated vaccine within 12 weeks prior to baseline or potential need to receive a live vaccine during the course of the study, Active participation in any other interventional study, Use of GC unless on stable oral dose =10mg for at least 4 weeks prior to study inclusion, Patients using NSAIDs, unless taken at a stable dose for =2 weeks prior to study inclusion, Intraarticular GC treatment in the last 8 weeks, Patients with significant and clinically relevant MTX-drug toxicity as judged by the investigator, Elevated liver enzymes (aspartate transaminase (ASAT) and/or alanine transaminase (ALAT)), and/or alkaline phosphatase (AP), and/or gamma-glutamyl transferase (GGT) above 2x the upper limit normal (ULN), Reduced kidney function (glomerular filtration rate (GFR)<60), Hematologic abnormalities (Grade 2 or 3: Anaemia, Leukopenia, Thrombocytopenia)
研究者
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