A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)

Pfizer Inc., 235 East 42nd Street, New York, NY 100170 个研究点目标入组 240 人2018年5月14日

适应症Ankylosing spondylitis (AS)MedDRA version: 20.0Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders Therapeutic area: Diseases [C] - Immune System Diseases [C20]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Ankylosing spondylitis (AS)
发起方: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
入组人数: 240
状态: 进行中（未招募）
最后更新: 7年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2018年5月14日

结束日期

待定

最后更新

7年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

入排标准

入选标准

•1\. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
•2\. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
•3\. Subject is at least 18 years old (20 years old for subjects in Taiwan) at the screening visit.
•4\. The subject has a diagnosis of AS based on the Modified New York Criteria for Ankylosing Spondylitis (1984\).
•5\. The subject must have a radiograph of the SI joints (AP Pelvis) documenting diagnosis of AS. Previous radiographs (up to 2 years old) can be used if they are accepted by the central reader. Otherwise, a new radiograph will be obtained at the Screening visit.
•6\. Subject has active AS Screening and Baseline (Day 1\) visits defined as:
•BASDAI score of \=4; and
•Back pain score (BASDAI Question 2\) of \=4\.
•7\. Subject has active disease despite nonsteroidal anti\-inflammatory drug (NSAID) therapy or is intolerant to NSAIDs
•8\. Subjects who are designated as TNFi\-IR must have received at least 1, but not more than 2 approved TNF inhibiting biologic agent that was administered in accordance with its labeling recommendations and was inadequately effective after the minimum treatment times listed below and/or not tolerated after one or more doses.

排除标准

•1\. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
•2\. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry and/or during study participation (excluding noninterventional follow\-up during the screening period).
•3\. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
•4\. History of known or suspected complete ankylosis of the spine. This can be determined/confirmed at the time of the SI radiograph by the central reader.
•5\. Subjects receiving any other conventional synthetic or biological DMARDs (other than those allowed), thalidomide (including previous use) and other prohibited concomitant medications.
•6\. Subjects that have been exposed to biological DMARDs other than TNF inhibitors.
•7\. Blood dyscrasias at screening or within 3 months prior to the first dose of investigational product including confirmed:
•Hemoglobin \<10 g/dL;
•Absolute white blood cell count (WBC) \<3\.0 x 10^9/L (\<3000 mm3\);
•Absolute neutrophil count (ANC) \<1\.5 x 10^9/L (\<1500 mm3\);