EUCTR2013-003666-13-DE
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
- Intervention
- Not specified
- Conditions
- Ankylosing Spondylitis
- Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Enrollment
- 212
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
- •\-\-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
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
- •\- 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)
Outcomes
Primary Outcomes
Not specified
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