2024-516723-14-00招募中4 期
A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 705
- 试验地点
- 23
- 主要终点
- Treatment Part 1: The primary efficacy outcome is the proportion of patients in remission at week 24 from baseline according to CDAI. Treatment Part 1: The primary radiographic outcome is the progression of total Sharp van der Heijde score after 48 weeks from baseline. Treatment Part 2: The primary efficacy outcome is the proportion of patients in remission according to CDAI, at the time point 24 weeks after the dose was first reduced.
研究概览
简要总结
The global aim of this study is to assess and compare 1) the proportion of subjects who achieve remission with active conventional therapy (ACT) versus three different biologic therapies; and 2) two alternative de-escalation strategies in patients who respond to first-line therapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥18 years of age.
- •Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
- •Subjects must be able and willing to self-administer s.c. injections or have a qualified person available to administer s.c. injections.
- •Subject has a diagnosis of RA as defined by the newly established ACR/EULAR criteria,
- •<24 months from arthritis symptom debut (symptom duration will be registered).
- •Subject must have DAS28 (CRP) > 3.
- •≥ 2 swollen joints AND ≥ 2 tender joints (based on 66/68 joint count)
- •Subject must fulfill one of the following three criteria: RF positive OR ACPA positive OR CRP ≥10 mg/L.
- •Female subject is either not of childbearing potential (postmenopausal, surgically sterile etc.), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion: • Intrauterine device (IUD) • Contraceptives (oral, parenteral, patch) for three months prior to study drug administration) • A vasectomized partner
- •Female subjects of childbearing potential must have a negative pregnancy test at the Screening visit.
- •Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination, chest X-ray (CXR), and 12-lead electrocardiogram (ECG) performed at Screening.
排除标准
- •Subject has been previously treated with disease modifying antirheumatic drugs (DMARDs) for rheumatic diseases
- •Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the study.
- •Subject has a history of clinically significant hematologic (e.g., severe anemia, leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis, hepatitis).
- •Subject has history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease and/or diagnosis of central demyelinating disease.
- •Subject has history of cancer or lymphoproliferative disease. Allowable exceptions: a. Successfully treated cutaneous squamous cell or basal cell carcinoma b. Localized carcinoma in situ of the cervix c. Curatively treated malignancy (treatment terminated) > 5 years prior to screening
- •Subject has a history of listeriosis, histoplasmosis, untreated TB, persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous (iv) anti-infectives within 30 days or oral anti-infectives within 14 days prior to the BL visit.
- •Subjects will be evaluated for latent TB infection with a PPD or QuantiFERON test and X-ray. Subjects with evidence for latent TB will not be enrolled but first assessed according to local guidelines.
- •Subject is known to have immune deficiency, history of Human Immunodeficiency Virus (HIV) or is otherwise severely immunocompromised.
- •Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study or within 150 days after the last dose of study medication.
- •Men who are planning to father a child during the time they are included in the study.
- •Subject has a history of clinically significant drug or alcohol usage in the last year.
- •Current active inflammatory joint disease other than RA.
- •Subject has a chronic widespread pain syndrome.
- •Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
- •Subject is unwilling to comply with the study protocol.
- •Screening clinical laboratory analyses show any of the following abnormal laboratory results: a. Aspartate transaminase (AST) or alanine transaminase (ALT) > 1.75 times upper limit of normal (ULN). b. Positive serum human chorionic gonadotropin (hCG). c. Positive tests for hepatitis B surface antigen (HBsAg) or hepatitis C serology indicative of current infection. d. Creatinine levels > 2x the ULN. If creatinine 1-2 times ULN, check GFR. e. Hemoglobin < 90 g/L. f. Absolute neutrophil count (ANC) < 1.5 x 10^3/uL. g. Serum total bilirubin ≥ 1.5 mg/dL (≥26 micromol/L).
- •Subject has had a dose of prednisone (or equivalent) >7.5 mg/day or has had a dose change within the preceding 4 weeks.
- •Subject has been treated with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks. Inhaled corticosteroids for stable medical conditions are allowed.
- •Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study).
- •Subject has chronic arthritis diagnosed before age 17 years.
- •Subject has a history of an allergic reaction or significant sensitivity to constituents of study drugs.
- •Subject has been treated with any investigational drug within one month prior to screening visit.
- •Active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization within 4 weeks of screening.
结局指标
主要结局
Treatment Part 1: The primary efficacy outcome is the proportion of patients in remission at week 24 from baseline according to CDAI. Treatment Part 1: The primary radiographic outcome is the progression of total Sharp van der Heijde score after 48 weeks from baseline. Treatment Part 2: The primary efficacy outcome is the proportion of patients in remission according to CDAI, at the time point 24 weeks after the dose was first reduced.
Treatment Part 1: The primary efficacy outcome is the proportion of patients in remission at week 24 from baseline according to CDAI. Treatment Part 1: The primary radiographic outcome is the progression of total Sharp van der Heijde score after 48 weeks from baseline. Treatment Part 2: The primary efficacy outcome is the proportion of patients in remission according to CDAI, at the time point 24 weeks after the dose was first reduced.
次要结局
未报告次要终点
研究者
Prof Ronald van Vollenhoven
Scientific
Karolinska Institutet
研究点 (23)
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