EUCTR2019-000660-25-PL进行中（未招募）1 期
A Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis
CELLTRION, Inc.0 个研究点目标入组 60 人开始时间: 2019年5月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •Each patient must meet all of the following criteria to be enrolled in this study:
- •1. Male or female patient between 18 to 70 years of age, inclusive.
- •2. Patient must be able and willing to self-administer subcutaneous (SC) injections via auto-injector (AI).
- •3. Patient with a diagnosis of rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for at least 24 weeks prior to the first administration of the study drug (Day 1).
- •4. Patient who has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed), 6 or more tender joints (of 68 assessed) and either an erythrocyte sedimentation rate (ESR) >28 mm/hour or a serum C-reactive protein (CRP) concentration >1.0 mg/dL (>10 mg/L) at Screening.
- •5. Patient who has been receiving oral or intramuscular (IM) methotrexate (MTX) at a dose of between 12.5 to 25 mg/week, or 10 mg/week if intolerant to a higher dose, for at least 12 weeks and who has been on a stable dose and route of MTX for at least 4 weeks prior to the first administration of the study drug (Day 1).
- •6. Patient has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results:
- •Serum creatinine =1.5 x upper limit of normal (ULN) or an estimated creatinine clearance level >50 mL/min (by Cockcroft-Gault formula) (Système International d'Unités [SI] units: 0.84 mL/second).
- •Serum alanine aminotransferase = 3.0 x ULN.
- •Serum aspartate aminotransferase = 3.0 x ULN.
- •Serum total bilirubin = 1.5 x ULN.
- •7. Patient has the following hematology laboratory test results at Screening:
- •Hemoglobin >8.0 g/dL (SI units: >80 g/L or 4.96 mmol/L).
- •Absolute neutrophil count = 1.5 x 10³ cells/µL.
- •Platelet count = 75x 10³ cells/µL.
- •8. Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side-effects, has the ability to cooperate with the Investigator and is given ample time and opportunity to read and understand verbal and/or written instructions, and signs the written informed consent form (ICF) with date prior to participation in the study.
- •9. Patient and their partner of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 6 months after the last dose of the study drug. Examples include the following:
- •Hormonal contraceptives (combined or progestogen-only) associated with inhibition of ovulation.
- •Intrauterine devices.
- •Sexual abstinence (not periodically, but for the entire period of risk associated with the study drug).
- •A man or woman is of childbearing potential if, in the opinion of the Investigator, he or she is biologically capable of having children and is sexually active. Male and female patients and their partners who have been surgically sterilized for less than 24 weeks prior to the date of informed consent must agree to use any medically acceptable methods of contraception. Menopausal females must have experienced their last period more than 1 year prior to the date of informed consent to be classified as not of childbearing potential.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •A patient meeting any of the following criteria will be excluded from the study:
- •1. Patient who has previously received or plans to receive investigational or licensed product; biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs) for the treatment of RA and/or a tumor necrosis factor (TNF) a inhibitor for any purposes.
- •2. Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
- •3. Patient who has previous or current use of other SC self-injected drugs.
- •4. Patient who currently has, or has a history of, any of the following infections:
- •o A known infection with hepatitis B (active or carrier of hepatitis B [HBV]), hepatitis C, or infection with human immunodeficiency virus (HIV). Patient will be enrolled based on HBV infection eligibility criteria.
- •o Hospitalization for treatment of infection within 24 weeks prior to the first administration of the study drug (Day 1).
- •o Symptomatic or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug (Day 1).
- •o Past or current granulomatous infections or other severe or chronic infections. A patient who has a past diagnosis with sufficient documentation of complete resolution of the infection can be enrolled in the study.
- •5. Patient is ineligible according to the following tuberculosis (TB) screening criteria:
- •o Patient who has a history or a current diagnosis of active TB.
- •o Patient who has had exposure to a person with active TB such as first-degree family members or co-workers.
- •o Patient who has an indeterminate result for interferon-? release assay (IGRA) or latent TB at Screening. A patient who has a previous diagnosis of latent TB cannot be enrolled despite sufficient documentation of completed TB prophylaxis. If the result of the IGRA is indeterminate at Screening, 1 retest will be possible during the Screening Period.
- •o Any other investigational device or medical product within 4 weeks prior to the first administration of the study drug (Day 1) or 5 half-lives, whichever is longer.
- •6. Patient who has current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled. Including one or more of the following:
- •o Classified as Class II or III obese by World Health Organization classification.
- •o Uncontrolled diabetes mellitus, even after an appropriate treatment.
- •o Uncontrolled hypertension.
- •o Any other inflammatory or rheumatic diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis, spondyloarthritis, systemic lupus erythematosus, Lyme disease, or fibromyalgia, that may confound the evaluation of the effect of the study drug.
- •o Significant systemic RA involvement (e.g., Sjögren’s syndrome, vasculitis, pulmonary fibrosis), which would put the patient at risk if they are enrolled.
- •o A known malignancy within the previous 5 years prior to the first administration of the study drug (Day 1) except completely excised and cured squamous carcinoma in situ of the uterine cervix in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
- •o A vaccination (live or live-attenuated) within 4 weeks prior to enrollment or Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to enrollme
研究者
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