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 Finland Ky0 sites212 target enrollmentOctober 31, 2013

Overview

No summary available.

Registry

who.int

Start Date

October 31, 2013

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\-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

•\-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