Apex - Clinical Research Study
This is a study of the efficacy and safety of guselkumab administered subcutaneously (sc) in participants with active Psoriatic Arthritis (PsA).
Minimum Age
18
Eighteen Years and Older
Diagnosis
PsA
Psoriatic Arthritis
PLACEBO CONTROLLED
YES
Potential Placebo for 24-Weeks
DURATION
60
Total Duration is 60 Weeks
STIPEND
$52
$52 Per Visit, $1,040 Max
Patient Benefits
Patients who screen and then enroll in the study will receive:
- Doctor Assessments
- Lab work and Safety Follow-ups
- Study drug (active, comparator, or placebo)
- $52.00 per completed study visit ($1,040 Maximum for the course of the study.)
Study Duration for Patients
The total study duration is approximately 60-weeks which typically consists of 12 visits during the course of the study.
The study consists of four periods:
- Screening Period (2 to 6 weeks before the treatment starts) to see if you are eligible to participate in the study.
- Study Treatment Period (52 weeks). This Study Treatment period includes a Double-Blind Study Treatment Period (24 weeks) and an Active Study Treatment-Blind Period (28 weeks).
- Long-Term Extension (108 weeks) (Optional). You can elect to remain on the study for an additional 108-week extension to help study long-term effects.
- Safety Follow-Up Visit (SFU visit) (8 weeks, after the last dose of study drug) This visit will ensure you have no long-term safety concerns after the end of treatment.
The study may also have some unplanned visits, most commonly for repeat lab work. For patients who enroll in the long-term extension, the maximum possible stipend increases to $2,600.
Guselkumab (Tremfya)
Guselkumab (Tremfya) is a monoclonal antibody.
- There is a 37% chance patients will receive guselkumab every 2 weeks.
- There is a 37% chance patients will receive guselkumab and placebo, alternating every 2 weeks. Patients on this study therapy will receive guselkumab once every 4 weeks.
- There is a 26% chance patients will receive placebo for the first 24 weeks of the study. After week 24, subjects will begin receiving guselkumab every 2 weeks.
This study is double-blind, meaning neither the patient nor the study team will know which investigational therapy the patient is receiving.
Study Location
64 Remick Blvd.
Springboro, OH 45066
Inclusion Criteria
The following must be met in order to qualify for the study.
- Must be at least 18 years of age or older.
- Female subjects must be postmenopausal, permanently sterilized, or willing to use a highly effective method of contraception, and agree to remain on it while receiving study therapy.
- Male subjects must agree to use a barrier method of birth control if sexually active with a woman of childbearing potential, or have had a vasectomy.
- Documented diagnosis of Psoriatic Arthritis (PsA) for at least 6 months prior to enrollment
- Subject must have at least 1 active psoriatic plaque and/or a documented history of psoriasis (PSO)
Exclusion Criteria
Patients with any of the following are ineligible to enroll in the study.
- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
- Subjects with any prior biologic treatment.
- Subjects that have an active infection or a history of recent serious infections
- Subjects that have known tuberculosis (TB) infection or are at high risk of acquiring TB infection.
- Subjects that have a diagnosis of inflammatory conditions other than PSO or PsA such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease.
- Subjects that have received Janus kinase (JAK) inhibitor treatment, including, but not limited to: tofacitinib, baricitinib, filgotinib, or decernotinib.
** Other eligibility criteria exist to enroll in the study. Study eligibility requirements are subject to change. STAT Research and Dr. Alappatt 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.
1-833-STAT-833
See if you Qualify!
Complete the form below and a research coordinator will contact you regarding phone or in-person pre-screening.
Study Investigator
Dr. Chacko Alappatt
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.