Eighteen Years and Older
Potential Placebo for 24-Weeks
Total Duration is 60 Weeks
$52 Per Visit, $1,300 Max
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 ($1,300 Maximum for the course of the study.)
Study Duration for Patients
The total study duration is approximately 60-weeks which consists of approximately 13 visits during the course of the study.
The study consists of three 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).
- 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.
Guselkumab (Tremfya) is a monoclonal antibody.
600 Aviator Ct.
Vandalia, OH 45377
The following must be met in order to qualify for the study.
- Female or male at least 18 years of age
- Female subjects must be postmenopausal, permanently sterilized, or willing to use a highly effective method of contraception
- 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)
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. Wolfe reserve the right to exclude patients who do qualify for other reasons. Enrollment is limited and may be closed at anytime without prior notice.
See if you Qualify!
Complete the form below and a research coordinator will contact you regarding phone or in-person pre-screening.
Dr. Sanford Wolfe, D.O.
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.