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Solstice - Clinical Research Study

This is a study to demonstrate the clinical efficacy and safety of guselkumab administered subcutaneously (sc) compared in participants with active Psoriatic Arthritis (PsA).

Solstice - Clinical Research Study

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, $1,300 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 ($1,300 Maximum for the course of the study.)

Study Duration

Study Duration for Patients

The total study duration is approximately 60-weeks which consists of approximately 16 visits during the course of the study.

The study consists of three periods:

  1. Screening Period (2 to 6 weeks before the treatment starts) to see if you are eligible to participate in the study.
  2. 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).
  3. 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.

Study Drug

Guselkumab (Tremfya)

Guselkumab (Tremfya) is a monoclonal antibody.

Study Location

600 Aviator Ct.
Vandalia, OH 45377

Inclusion Criteria

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
  • Documented diagnosis of Psoriatic Arthritis (PsA) for at least 6 months prior to enrollment
  • Subject must have at least 1 active psoriatic lesion(s) 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 more than 1 prior anti-TNF agent
  • Subjects that have an active infection or a history of recent serious infections
  • Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) 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.

How to contact us...

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.

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A telephone number where we can contact you.

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. 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.

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