A 48 weeks, phase II, randomized, double-blind, placebo-controlled, proof of concept and dose finding study of three different dose regimens of BI 655066 administered subcutaneously in patients with ankylosing spondylitis. - BI 1311.8

Boehringer Ingelheim Pharma GmbH & Co. KG0 个研究点目标入组 212 人开始时间: 2013年11月1日最近更新: 2016年8月8日

适应症

试验速览

暂无简介。

•-Male and female patients
•-Age >= 18 years and =< 70 years.
•- Definite AS based on the modified New York criteria (1984)
•-Documented disease duration > 3 months at screening
•-Active disease at screening, defined as:
•--BASDAI score (0-10) >= 4, AND
•--Spinal pain level assessed by patient on NRS (0-10) >= 4 (2nd question from BASDAI will be used here)
•-Have either a documented inadequate response for axial symptoms to 30 days of optimal daily doses of at least two non-steroidal anti-inflammatory drugs (NSAIDs), or documented intolerance to NSAIDs
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•-Radiographic evidence of total ankylosis of the spine at screening or before (spinal X-Ray examinations at screening visit/ during screening period are not mandatory - see footnote 12 from Flow-Chart 1).
•-Patient previously treated with any biological immunomodulating agent for AS, either licensed or experimental
•-Previous or current participation in a clinical trial testing an investigational drug for AS
•-Usage of any investigational drug within 30 days prior to randomization or the planned use of an investigational drug during the course of the actual study
•-Active uveitis or inflammatory bowel disease at screening
•-Diagnosed psoriatic arthritis at screening, satisfying the modified New York criteria
•-Patients who had received intraarticular injection(s) with corticosteroids within 4 weeks prior to screening visit
•- Male patients = 50 years and = 70 years at screening Female patients = 18 years and = 70 years at screening (according to local German protocol amendment 3, EXCLUSION OF MALE PATIENTS < 50 YEARS)

发起方