AbbVie M16-852 Clinical Research Study
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (also known as Temporal Arteritis).
Patient Benefits
If you pass screening and enroll in the study you will receive:
- You may receive study drug (active or placebo), lab work, and visit exams at no cost.
- You will be reimbursed $95.00 per completed study visit for transport costs with a maximum benefit of $2,375 for the course of the study.
Study Duration for Patients
The total study duration is approximately 104-weeks which consists of approximately 20 visits during the course of the study.
The study consists of four periods:
- Screening Period (2 to 5 weeks before the treatment starts) to see if you are eligible to participate in the study.
- Period 1 (52 weeks). In Period 1 of the study, you will be randomly assigned by chance (like the flip of a coin) to receive either upadacitinib plus a corticosteroid (CS) taper or placebo plus a CS taper. You will have a 75% chance of receiving upadacitinib and a 25% chance of receiving placebo.
- Period 2 (52 weeks). If you have no GCA signs and symptoms for at least 16 weeks before your Week 52 visit you will then continue to Period 2. If you were assigned to receive upadacitinib in Period 1, you will be randomly assigned to continue receiving the same dose of upadacitinib or switch to placebo. You will have a 66% chance of continuing to receive upadacitinib and a 33% chance of receiving placebo.
- Safety Follow-Up (approximately 30 days after final dose of study drug). This visit is for all patients who leave the study early or complete the study.
The study may also have some unplanned visits, most commonly for repeat lab work.
Upadacitinib
Upadacitinib is an investigational JAK1 inhibitor medication.
Inclusion Criteria
To qualify, you must meet these requirements for the study...
- Diagnosis of giant cell arteritis (GCA)
- Active GCA, either new onset or relapsing, within 6 weeks of Baseline.
- You must have received treatment with >=40 mg prednisone (or equivalent) at any time prior to Baseline and be receiving prednisone (or equivalent) >= 20 mg once daily at Baseline.
- You must have GCA that, in the opinion of the investigator, is clinically stable
- Females must either be postmenopausal, surgically sterile, or practicing at least 1 specified method of birth control through the study.
Exclusion Criteria
Patients with any of the following are ineligible to enroll in the study.
- Prior exposure to any Janus Kinase (JAK) inhibitor.
- Treatment with an interleukin-6 (IL-6) inhibitor within 4 weeks of study start, or prior treatment with an IL-6 inhibitor and experienced a disease flare during treatment.
- Use of any certain systemic immunosuppressant treatments within the specified time frame prior to study start.
- Current or past history of infection including herpes zoster or herpes simplex, HIV, active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.
- Females who are pregnant, breastfeeding or considering pregnancy during the study.
** Other eligibility criteria exist to enroll in the study. Study eligibility requirements are subject to change. STAT Research and the study Investigator reserve the right to exclude patients who do qualify for other reasons. Enrollment is limited and may be closed at any time without prior notice.
Study Location
600 Aviator Ct.
Vandalia, OH 45377
See if you Qualify!
Complete the form below and a coordinator will contact you regarding a phone or in-person pre-screening.
1-833-STAT-833
Study Investigator
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. Dr. Wolfe is board certified in Internal Medicine and Rheumatology. Dr. Wolfe is a renowned leader in regards to clinical research trials, with over 20 years of experience and led more than 120 studies within the Rheumatology therapeutic area.
