AbbVie M19-944
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis
Patient Benefits
Patients who screen and then enroll in the study will receive:
- Study drug (active, comparator or placebo), lab work, visits are included at no cost.
- Patients will be reimbursed $100.00 per completed study visit for transport costs with a maximum benefit of $2,900 for the course of the study.
Study Duration for Patients
The total study duration is approximately 104-weeks which consists of approximately 19 visits during the course of the study, with a safety follow up approximately 30 days after the final study visit.
Study Location
66 Remick Blvd.
Springboro, OH 45066
Study Design
This is a global Phase 3, multicenter, protocol with a common screening platform. The master study includes 2 independent studies for subjects with active Axial Spondylarthritis.
Study 1 is comprised of a 35-day Screening Period; a 14-week randomized,
double-blind, parallel-group, placebo-controlled period; a 90-week open-label, long-term extension period; and a 30-day Follow-Up Visit.
Study 2 is comprised of a 35-day Screening Period; a 52-week randomized, double-blind, parallel-group, placebo-controlled period; a 52-week open-label, long-term extension period; and a 30-day F/U Visit.
Frequently Asked Questions
- What does “double-blind” mean?
- “Double-blind” means that you will not know if you are receiving the study drug or placebo, and the doctor will also not know if you are on study drug or placebo. Only the study sponsor will know.
- If there is a placebo, does that mean there is a chance I won’t be receiving any medication for my Axial Spondyloarthritis?
- In this study, no. All subjects will be receiving doses of study drug, after the double blind phase of each study.
- Will I get paid to be on the study?
- No, however all subjects will receive a $100 travel stipend per completed study visit, to cover any service fares, gas, and/or common wear and tear to vehicles.
- If I change my mind after starting the study, do I have to complete every visit?
- You participation in the study is completely voluntary. At any point in time, if you wish to withdrawl your consent you can. We will schedule you for safety monitoring visits, but you will no longer receive study drug.
- How can I find out if my insurance is accepted?
- All study related activities are completed free of charge, so insurance is not required!
See if you Qualify!
Complete the form below and a research coordinator will contact you regarding phone or in-person pre-screening.
1-833-STAT-833
Study Investigator
Dr. Chacko Alappatt, M.D.
Principal Investigator
Dr. Alappatt is a graduate of Northeastern Ohio Universities College of Medicine and spent his residency at Indiana University. He operates and serves as Medical Director for the Arthritis & Osteoporosis Center of Southwest Ohio, an adult rheumatology group. Dr. Alappatt began his clinical research experience in 2007. He is passionate about his work as a research investigator and in providing exceptional care for his patients.
