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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01870284
Date of registration: 03/06/2013
Prospective Registration: Yes
Primary sponsor: Eli Lilly and Company
Public title: Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) SPIRIT A1
Scientific title: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients With Active Ankylosing Spondylitis
Date of first enrolment: July 2014
Target sample size: 0
Recruitment status: Withdrawn
URL:  http://clinicaltrials.gov/show/NCT01870284
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Argentina Belgium Canada Czech Republic France Germany Hungary Mexico
Netherlands Poland Russian Federation Spain Ukraine United Kingdom United States
Contacts
Name:     Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address: 
Telephone:
Email:
Affiliation:  Eli Lilly and Company
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray)
fulfilling the Modified New York criteria for AS (1984)

- Have active AS defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
=4 and the spinal pain (back pain) score =4 on a numeric rating scale (NRS)

- Participants should have been on nonsteroidal anti-inflammatory drugs (NSAIDs) with
an inadequate response

- Participants who are regularly taking NSAIDs or cyclooxygenase-2 (COX-2) inhibitors
as part of their AS therapy are required to be on a stable dose

- Participants who have been on a tumor necrosis factor alpha (TNF) inhibitor (not more
than one) must have experienced an inadequate response

- Total duration of prior therapy (NSAIDs and/or adequate physical therapy) should be
at least 12 weeks

- Men must agree to use a reliable method of birth control or remain abstinent during
the study

- Women must agree to use reliable birth control or remain abstinent during the study
and for at least 12 weeks after stopping treatment

Exclusion Criteria:

- Participants with a total ankylosis of the spine

- Prior or current treatment with adalimumab

- Participants previously treated with any biological or other immunomodulating agents
except for those targeting TNF

- Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other
than ankylosing spondylitis

- Have participated in any study with interleukin 17 (IL-17) antagonists, including
ixekizumab

- Serious disorder or illness other than ankylosing spondylitis

- Serious infection within the last 3 months

- Breastfeeding or nursing (lactating) women



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Spondylitis, Ankylosing
Intervention(s)
Drug: Adalimumab
Drug: Ixekizumab
Drug: Placebo
Primary Outcome(s)
Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20) [Time Frame: 16 Weeks]
Secondary Outcome(s)
Efficacy of Ixekizumab in Participants with AS. Measure: modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) [Time Frame: Baseline through 108 Weeks]
Efficacy of Ixekizumab in Participants with AS. Measure: Non-Arthritic Disease Assessments [Time Frame: Baseline through 16 Weeks]
Efficacy of Ixekizumab in Participants with AS. Measure: Peripheral Joint Counts [Time Frame: 16 Weeks]
Efficacy of Ixekizumab in Participants with AS. Measure: ASAS [Time Frame: 16 Weeks]
Efficacy of Ixekizumab in Participants with AS. Measure: Spinal Mobility [Time Frame: Baseline through 16 Weeks]
Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) [Time Frame: Baseline through 16 Weeks]
Secondary ID(s)
13650
I1F-MC-RHAO
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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