PER-050-10尚未招募未知
A RANDOMIZED, DOUBLE BLIND, PARALLEL-GROUP, PHASE 3 STUDY TO DEMONSTRATE EQUIVALENCE IN EFFICACY AND SAFETY OF CT-P13 COMPARED WITH REMICADE WHEN CO-ADMINISTERED WITH METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS
Celltrion, Inc.,0 个研究点目标入组 0 人开始时间: 2010年9月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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 75（—）
入选标准
- •1. Patient is male or female aged 18 to 75 years old, inclusive.
- •2. Patient was diagnosed with active RA according to the revised 1987 ACR classification criteria [Arnett et al 1987] for at least 1 year prior to Screening.
- •3. Patients have active disease as defined by the presence of 6 or more tender joints, and 6 or more tender joints, and at least two of the following: morning stiffness lasting at least 45 minutes, an erythrocyte sedimentation rate greater than 28mm/h, and a serum C-reactive protein (CRP) concentration greater than 2.0 mg/dL [Maini et al 1999].
- •4. Patients who have completed at least 3 months of treatment of oral or parenteral dosing with methotrexate
- •between 12.5 to 25 mg/week and on stable dosing with methotrexate between 12.5 to 25mg/week for at least 4 weeks prior to Screening.
- •5. Both male and female patients and their partners of childbearing potential must agree to use2 medically accepted methods of contraception (eg, barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study and for
- •6 months following discontinuation of study treatments (excluding women who are not of childbearing potential and men who have been sterilized).
- •6. Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to study entry must agree to use 2 medically accepted methods of contraception as per inclusion criterion 5.
- •7. Menopausal females must have experienced their last period more than 12months prior to study entry to be classified as not of childbearing potential.
- •8. Patients have adequate renal and hepatic function at Screening as defined by the following clinical
- •chemistry results:
- •Serum creatinine <1.7 x upper limit of normal (ULN) or an estimated creatinine clearance level >75 mL/min
- •Serum alanine aminotransferase <2 x ULN
- •Serum aspartate aminotransferase <2 x ULN
- •9.Patients are permitted to receive both oral glucocorticoids equivalent to <10 mg daily prednisolone and
- •nonsteroidal anti-inflammatory drugs, if they have received a stable dose for at least 4 weeks prior to Screening.
- •10. Patients have the ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to cooperate with the investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study.
- •11. Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information, signed and dated the written informed consent before inclusion in the study.
排除标准
- •1. Patients who have previously been administered a biological agent for the treatment of RA.
- •2. Patients who have allergies to any of the excipients of infliximab or any other murine and human proteins.
- •3. Patients who have a current or past history of chronic infection with hepatitis B, hepatitis C, or infection
- •with human immune deficiency virus -1 or -2 or who have a positive result to the screening test for those infections.
- •4. Patients who have a current diagnosis of tuberculosis (TB) or other severe or chronic infection (such as sepsis, abscess or opportunistic infections, or invasive fungal infection such as histoplasmosis) or a past diagnosis without sufficient documentation of complete resolution following treatment.
- •5. Patients who have had recent exposure to persons with active TB, or who have a positive result to the screening test for latent TB defined as a positive result of interferon-y release assay with a negative examination of chest x-ray, and who have not received at least the first 30 days of country-specific TB therapy and do not intend to complete the entire course of that therapy.
- •6. Patients who have had any other serious infection not already excluded in the 6 months before Screening or
- •with a history of chronic infection.
- •7. Patients who have a current or past history of drug or alcohol abuse.
- •8. Patients who have a medical history including one or more of the following conditions:
- •Bone marrow hypoplasia
- •Diabetes mellitus unless on a stable dosing regimen for at least 4 weeks prior to Screening; patients must maintain stable dosing throughout the study.
- •Any other inflammatory rheumatic disease and other chronic painful musculoskeletal or neuropathic conditions such as fibromyalgia.
- •Any malignancy within the previous 5 years except completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma or squamous cell carcinoma.
- •Congestive heart failure (New York Heart Association Class III/IV) or unstable angina.
- •Organ transplantation.
- •Severe physical incapacitation.
- •Moderate, severe or very severe chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease criteria.
- •Previous diagnosis or symptoms suggestive of demyelinating disorders, including multiple sclerosis and Guillan-Barre syndrome.
- •Any condition significantly affecting the nervous system (ie, nervous system damage) if it may interfere with the investigator´s assessment on disease activity scores including joint counts)
- •Patients with seizure disorder
- •9. Patients taking any of the following concomitant medications:
- •Corticosteroids except oral glucocorticoids of maximum equivalent daily dose of 10 mg of prednisolone within 4 weeks prior to Screening.
- •Disease-modifying antirheumatic drugs, other than methotrexate, within 4 weeks prior to Screening. Patients who discontinued leflunomide and have had successful chelation with 8 g of cholestyramine (3 times daily) for 11 days must wait 4 weeks prior to Screening. Patients who discontinued leflunomide and did not have cholestyramine washout must wait 12 weeks after last dose leflunomide before Screening.
- •Alkylating agents within 12 months prior to Screening.
- •10. Patients who have participated in a study with an investigational drug within 6 months of Screening or who are currently receiving treat
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