EUCTR2013-003666-13-ES
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 212
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •\- 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:
- •a. BASDAI score (0\-10\) \>\= 4, AND
- •b. Spinal pain level assessed by the 2nd BASDAI question (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
Exclusion Criteria
- •\- 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
Investigators
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