PER-112-10已完成未知
A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, PHASE 1 STUDY TO DEMONSTRATE THE EQUIVALENCE WITH RESPECT TO THE PHARMACOKINETIC PROFILE OF CT-P13 AND REMICADE IN PATIENTS WITH ANKYLOSING SPONDYLITIS.
Celltrion, Inc.,0 个研究点目标入组 0 人开始时间: 2011年2月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
- •The patient is male or female between 18 and 75 years of age, inclusive.
- •The patient was diagnosed with active AS according to the classification criteria of New York {modified in 1984 [van der Linden et al 1984] at least 3 months before the Selection.
- •Patients have active disease as defined by the Bath Index for Ankylosing Spondylitis Disease Activity Index [BASDAl] with a score of> 4 (range 0 to 10) by at least 3 months before the Selection.
- •Patients have a visual analog scale score for pain in the column of> 4 (range 0 to 10).
- •Both men and women and their partners with reproductive potential should agree to use 2 medically approved contraceptive methods (eg, barrier contraceptives [male condom, female condom, or spermicidal diaphragm gel], hormonal contraceptives [implants, injections, combination of oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study and for 6 months after discontinuation of the study treatments (excluding women who do not have reproductive potential and men who have been sterilized ).
- •Male and female patients and their partners who have been surgically sterilized for less than 6 months before entering the study must agree to use 2 medically accepted contraceptive methods according to the inclusion criteria
- •Menopausal women must have submitted their last period more than 12 months before entering the study to be classified as without reproductive potential.
- •Patients have adequate renal and hepatic function in the Selection
- •Patients are allowed to receive both oral glucocorticoids equivalent to <10 mg prednisolone daily, and nonsteroidal anti-inflammatory drugs, whether they received a stable dose for at least 4 weeks prior to selection.
- •Patients have the ability to fully understand the nature and intention 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.
- •The patient (or legal representative, if applicable) is informed of the nature and purpose of the study, including possible risks and side effects, and is given enough time and opportunity to read and understand this information, sign and date the consent informed before inclusion in the study.
排除标准
- •Patients who have previously been given a biological agent for the treatment of AS.
- •Patients who have total spinal ankylosis, as defined by syndesmophytes present in the lateral views of spine radiographs at all intervertebral levels, from T6 to S1, inclusive.
- •Patients who have allergies to any of the infliximab excipients or any other murine and human protein.
- •Patients who have a current or past history of chronic infection with hepatitis B, hepatitis C or infection with human immunodeficiency virus -1 or -2 or who have a positive result for these infections in the National Team.
- •Patients who have a current diagnosis of tuberculosis (TB) or other severe or chronic infection (such as sepsis, abscesses or opportunistic infections, or an invasive fungal infection such as histoplasmosis) or a past diagnosis without sufficient documentation of complete recovery after treatment.
- •Patients who have recently been exposed to people with active TB, or who have a positive result to the screening test for latent TB defined as a positive result of the interferon-release assay and with a negative evaluation of the 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 all that therapy.
- •Patients who have had another serious infection that has not been excluded in the 6 months prior to the Selection or who have a history of chronic infections.
- •Patients who have a current or past history of drug or alcohol abuse.
- •Patients who have participated in a study with an investigational drug within 6 months prior to the Selection or who are currently receiving treatment with any other investigational medication or device.
- •Female patients who are currently pregnant or breastfeeding, or who are planning to become pregnant or breastfeed within 6 months after the last dose of CT-P13 or the Remicade reference product.
- •Patients who have received a live or live attenuated vaccine within 8 weeks prior to the Selection or who are scheduled to receive a live or live attenuated vaccine. Dead vaccines are accepted during the study.
- •Patients who, in the opinion of their general practitioner or Researcher, should not participate in the study
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