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NCT03129100 · ClinicalTrials.gov registry record · Phase 3
A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
A Phase 3 study of Axial Spondyloarthritis, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 773
- Enrollment target
- 20
- Study locations
NCT03129100: Completed Phase 3 study of Axial Spondyloarthritis, sponsored by Eli Lilly and Company.
NCT03129100 is a Phase 3 study of Axial Spondyloarthritis that has completed, run by Eli Lilly and Company. The registered enrollment target is 773 participants, above the 301-participant average among 4 other Axial Spondyloarthritis trials with a reported enrollment target (157% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03129100, a Phase 3 study of Axial Spondyloarthritis, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 773 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.
Primary Outcome
A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS \>3.5 at any visit during Period 2. ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total ba
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ixekizumab
Study Locations (20)
California
- Care Access Research - Huntington Beach - Huntington Beach
- Desert Medical Advances - Palm Desert
Florida
- Arthritis Rheumatic Disease Specialties - Aventura
- Sarasota Arthritis Center - Sarasota
Maryland
- Klein and Associates MD, PA - Cumberland
- Klein and Associates MD, PA - Hagerstown
North Carolina
- Shanahan Rheumatology & Immunotherapy, PLLC - Raleigh
- Carolina Arthritis Associates - Wilmington
Arizona
- Arizona Arthritis & Rheumatology Research - Phoenix
Colorado
- Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC - Colorado Springs
Connecticut
- Clinical Research Center of CT/NY - Danbury
Georgia
- Marietta Rheumatology - Marietta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 773 participants |
| Start Date | 2017-05-09 |
| Est. Completion | 2021-05-27 |
| Phase | Phase 3 |
What the finished NCT03129100 record still lists
NCT03129100 is an interventional study that assigns participants to a tested intervention. The registered 773 participants enrollment target is mid-sized for trials with a published cap, above the 301-participant average among 4 other Axial Spondyloarthritis trials with a reported enrollment target (157% higher).
The record links to 1 condition, with Axial Spondyloarthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03129100 names 20 study sites across 16 states, led by California, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT03129100 about?
NCT03129100 is a clinical study titled "A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis". The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.
What is the current status of trial NCT03129100?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 773 participants. The study started on 2017-05-09. Estimated completion is 2021-05-27.
What conditions does trial NCT03129100 study?
This clinical trial studies the following conditions: Axial Spondyloarthritis.
What interventions are being tested in trial NCT03129100?
The interventions under investigation include: Placebo (DRUG), Ixekizumab (DRUG).
Who is sponsoring clinical trial NCT03129100?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03129100 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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