A RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND, PHASE 3 STUDY TO COMPARE EFFICACY AND SAFETY OF CT-P17 WITH HUMIRA WHEN CO-ADMINISTERED WITH METHOTREXATE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS

CELLTRION, INC.,0 个研究点目标入组 28 人开始时间: 2018年12月5日最近更新: 2023年9月4日

适应症

试验速览

阶段: 未知
状态: 招募中
发起方
入组人数: 28

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•1. Patient is male or female aged 18 to 75 years old, both inclusive.
•2. Patient has had a diagnosis of RA according to the 2010 ACR/EULAR classification criteria (Aletaha et al., 2010) for at least 24 weeks prior to the first administration of the study drug (Day 1).
•3. 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.
•4. Patient who has been receiving oral or parenteral 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).
•5. Patient has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results:
•Serum creatinine 1.5  upper limit of normal (ULN) or an estimated creatinine clearance level >50 mL/min (by Cockcroft-Gault formula) (SI [Système International d´Unites] units: 0.84 mL/s)
•Serum alanine aminotransferase 3.0  ULN
•Serum aspartate aminotransferase 3.0  ULN
•Serum total bilirubin 1.5  ULN
•6. 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  103 cells/µL (SI units: 1.5  109 cells/L)
•Platelet count 75  103 cells/µL (SI units: 75  109 cells/L)
•7. 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 with date prior to participation in the study.
•8. 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 assigned treatment. 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).
•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.
•9. Patient must be able and willing to self-administer SC injections or designate a qualified person(s) to administer SC injection.

排除标准

•1. Patient who has previously received investigational or licensed product; biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or a tumor necrosis factor (TNF) α 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 currently has, or has a history of, any of the following infections:
•A known infection with hepatitis B (active or carrier of hepatitis B), hepatitis C, or infection with human immunodeficiency virus (HIV). However, a patient with past hepatitis B virus is allowed if resolved.
•Acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug (Day 1)
•Recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug (Day 1)
•Past or current granulomatous infections or other severe or chronic infections (such as sepsis, abscess, opportunistic infections, or invasive fungal infections such as histoplasmosis). A patient who has a past diagnosis with sufficient documentation of complete resolution of the infection can be enrolled in the study.
•Other serious infections within 24 weeks prior to the first administration of the study drug (Day 1)
•4. Patient who currently has, or has a history of, any of the following tuberculosis (TB):
•Patient who has a history of TB or a current diagnosis of TB. A patient who has a previous diagnosis of active TB cannot be enrolled in the study even if there is sufficient documentation of complete resolution of active TB.
•Patient who has had exposure to a person with active TB such as first-degree family members or co-workers.
•Patient who has an indeterminate result for interferon-γ release assay (IGRA) or latent TB (defined as a positive result of IGRA with a negative examination of chest X-ray) at Screening. A patient who has a previous diagnosis of latent TB cannot be enrolled despite sufficient documentation of prophylaxis. If the result of the IGRA is indeterminate at Screening, 1 retest will be possible during the Screening period. If the repeated IGRA result is indeterminate again or positive, the patient will be excluded from the study. If the repeated IGRA result is negative, the patient can be enrolled in the study.
•5. Patient who has a medical condition including one or more of the following:
•Classified as Class II or III obese by WHO classification (body mass index [BMI] 35 kg/m2)
•Uncontrolled diabetes mellitus, even after insulin treatment
•Uncontrolled hypertension (as defined by systolic blood pressure [BP] 160 mmHg or diastolic BP 100 mmHg)
•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
•Significant systemic RA involvement (e.g., Sjogren’s syndrome, vasculitis, pulmonary fibrosis), which would put the patient at risk if they are enrolled
•A known malignancy within the previous 5 years prior to the first administration of the study

研究者

发起方

CELLTRION, INC.,

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