EUCTR2021-006665-38-PL进行中（未招募）1 期
APPRAIS - A 24-week multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety and tolerability of orally administered Rabeximod in patients with active, moderate to severe rheumatoid arthritis with inadequate response to methotrexate - APPRAIS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Cyxone AB
- 入组人数
- 160
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
- 性别
- All
入选标准
- •1.Patients must give written informed consent before any trial-related assessment is performed.
- •2.Male or non-pregnant, non-lactating female patients at least 18 years of age. Women of childbearing potential will be screened after a confirmed menstrual period.
- •3.Established RA diagnosis according to the 2010 ACR/EULAR classification or the 1987 criteria.
- •4.Active RA (DAS28-CRP score =3.2) with at least 6 swollen joints and 6 tender joints using the 28 joint count.
- •5.hsCRP levels =5 mg/L at screening.
- •6.Patients must have taken oral or parenteral MTX 7.5-25 mg/week continuously for at least 12 weeks, with at least 6 weeks of stable dose prior to screening and throughout the duration of the trial.
- •7.Patients taking systemic corticosteroids must be on a stable dose of =10 mg/day prednisone or equivalent for at least 4 weeks before screening.
- •8.Patients taking hydroxychloroquine must be on a stable dose for at least 8 weeks before screening
- •9.Patients who are regularly taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or COX-2 inhibitors or paracetamol/acetaminophen as part of their RA therapy are required to be on a stable dose for at least 4 weeks before 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 91
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 69
排除标准
- •1.RA patients functional status class IV classified according to the ACR 1991 revised criteria.
- •2.Patients taking high potency opioid.
- •3.Use of strong CYP3A4 inhibitors within 2 weeks prior to screening and during the trial.
- •4.Previous long-term use of TNFa, T-cell co stimulation inhibition, IL-6 receptor blockers, anti B-cell therapy and Janus Kinase inhibitors.
- •5.Any therapy by intra-articular and intramuscular injections within 4 weeks before screening.
- •6.Treatment with hydroxychloroquine at a dose >5 mg/kg/day for >5 years
- •7.Pregnant or nursing women.
- •8.Women of child-bearing potential unless:
- •a) Women who observe total abstinence when this is in line with the preferred and usual lifestyle of the patient during the trial participation until 58 days from the last dose of the study drug.
- •b) Women whose partners have been sterilized by vasectomy or other means.
- •c) Women using a highly effective method of birth control.
- •9.Male patients must be using two acceptable methods of contraception for the entire duration of the trial, up to the End of Treatment visit and refrain from fathering a child in the at least 118 days months following the last IMP administration. Vasectomised partner is a highly effective birth control method.
- •10.Inflammatory diseases other than RA that might confound the evaluation of the benefit of rabeximod therapy.
- •11.Laboratory evidence of underlying metabolic, haematologic, renal, hepatic, pulmonary, neurologic, endocrine, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk.
- •12.Recent myocardial infarction, coronary revascularization, or percutaneous angioplasty; acute coronary syndrome; chronic uncompensated heart failure or New York Heart Association Functional Class III or IV; left ventricular assist devices; implanted defibrillators.
- •13.History of clinically significant alcoholic liver disease or liver.
- •14.History of severe chronic renal insufficiency, or patients with one kidney, or a creatinine level exceeding 1.5 mg/dL.
- •15.Screening total whole blood cell count <3,000/µL, or platelets <100,000/µL or neutrophils <1,500/µL or hemoglobin <8.5 g/dL.
- •16.Active systemic infections during the last two weeks prior to screening.
- •17.Infection with tuberculosis, HIV, hepatitis B or hepatitis C by a positive test at screening:
- •a) Patients with positive or indeterminate tuberculosis test at screening can be eligible if they have all of the following:
- •- No clinical features of active tuberculosis.
- •- Completed appropriate treatment for active or latent tuberculosis.
- •- No history of re-exposure since their treatment was completed.
- •- Chest x-ray with no evidence of active tuberculosis.
- •b) If the HIV test result is positive, the patient cannot be enrolled.
- •c) At Screening:
- •- If the HBsAg test result is positive, the patient cannot be enrolled.
- •- If a patient has results of HBsAg (negative), HBsAb (negative or positive), and HBcAb (positive), a hepatitis B virus (HBV) DNA test will be performed at Screening.
- •If the HBV DNA test result is positive, the patient cannot be enrolled.
- •If the HBV DNA test result is negative and the patient does not have any evidence of liver cirrhosis, the patient can be enrolled.
- •d) At Screening:
- •- If the HCV RNA test result is positive, the patient cannot be enrolled.
- •- If the HCA result is positive and HCV RNA test result is negative, the patient can be enrolled as long as the pa
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