M16-063 Clinical Research Trial

This study is a Phase 2 Study, which will investigate the safety and effectiveness of ABBV-105 when given alone or with Upadacitinib. The subjects will need to have previously taken conventional synthetic DMARDs for active Rheumatoid Arthritis, and shown an inadequate response or intolerance to biologic DMARDs.

M16-063 Clinical Research Trial
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Patient Benefits

Patients who enroll in the study will receive:

  • Study drug (active, comparator or placebo)
  • Lab work, and doctor visits included at no cost
  • Reimbursment of $55.00 per completed study visit for transport costs with a maximum benefit of $880 for the course of the study.

Study Duration

Study Duration for Patients

The total study is approximately 20-weeks and consists of roughly 7 visits. Visits include a screening visit, treatment visits, and a safety follow-up visit. There may be some additional appointments required for safety monitoring.

Study Location

600 Aviator Ct.
Vandalia, OH 45377

How does it work?

Study Design

This study will evaluate the safety and effectiveness of ABBV-105 and ABBV-599 against a control group that will be given a placebo. Participants will still take their csDMARDs.

Frequently Asked Questions

What is a placebo?

Placebo is a substance that looks like a drug but has no drug in it.

If there is a placebo, does that mean there is a chance I won’t be receiving any medication for my RA?

There is a 1 in 12 chance that you will receive only placebo during the 12 week study period. All other subjects will receive either ABBV-105, upadacitinib, or both.

Will I get paid to be in the study?

No. All subjects will receive a $55 travel stipend per completed study visit. This can be used to cover any service fares, gas, or wear and tear to vehicles.

If I change my mind after starting the study, do I have to complete every visit?

Your participation in the study is completely voluntary. You can withdraw your consent at any time. We will schedule you for a safety monitoring appointment, but you will no longer take study drugs.

How can I find out if my insurance is accepted?

Insurance is not required because all study-related activities are completed free of charge.

See if you Qualify!

Complete the form below and a research coordinator will contact you regarding phone or in-person pre-screening.

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Study Investigator

Dr. Sanford Wolfe, D.O.
Dr. Sanford Wolfe, D.O.

Principal Investigator

Dr. Wolfe is a graduate of Des Moines University College of Osteopathic Medicine and has been practicing Rheumatology for over 40 years. He is board certified in Internal Medicine and Rheumatology. Dr. Wolfe is renowned as a leader in clinical research trials, with over 20 years of experience. He has led more than 120 studies.

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