Rheumatoid Arthritis Self-Scheduler

Basic Criteria  

• Age 18-75 
• BMI 18-35
• Must be diagnosed with adult-onset Rheumatoid Arthritis for at least 3 months 
• Currently being treated with at least 1 BUT no more than 2 permitted meds for RA for at least 12 weeks, at a stable dose for at least 6 weeks prior to Day 1 
  • Use of oral, intramuscular, or subcutaneous methotrexate5 to 25 mg/week
  • Oral hydroxychloroquine ≤ 400 mg/day or chloroquine ≤ 250 mg/day
  • Oral sulfasalazine 1 to 3 g/day
  • Oral leflunomide 10 to 20 mg/day

Answers Must be NO 

• If female, are you currently pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study? 

• Do you have a diagnosis of any generalized musculoskeletal disorder that would interfere with study procedures or assessments? For example:
  • Generalized osteoarthritis, juvenile idiopathic arthritis, inflammatory bowel disease associated arthropathies, systemic lupus, scleroderma inflammatory myopathy, mixed connective tissue disease, an overlap syndrome, systemic vasculitis or gout
    • Exceptions: participants with secondary Sjogren’s syndrome or secondary limited cutaneous vasculitis with RA are not excluded. Coexisting fibromyalgia under control for several months. 

• Do you currently abuse drugs or alcohol, or heavy tobacco user? Cocaine use is exclusionary 

• Do you have any active TB, Hepatitis B, Hepatitis C, COVID-19, or history of HIV? 

• Do you have any known hypersensitivity or allergy to study drugs and their metabolites, or their formulation excipients? 

•  Do you have any active infection that is clinically significant or had any infection requiring hospitalization or treatment with intravenous anti-infectives in the past 60 days; or oral anti-infective therapy in the past 30 days? 

• Do you have a history of or current moderate to severe congestive heart failure (New York Heart Association class III or IV)? 

• Within the last 6 months have you had: a stroke, heart attack, unstable angina, unstable arrhythmia, or any other cardiovascular condition which would interfere with study participation? 

• Do you have a history of cancer within the past 5 years prior to screening?
  • Except for adequately treated basal cell carcinoma or nonmetastatic squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix, which is considered cured with minimal risk of recurrence? 

• Do you have a history of or active lymphoproliferative disease (uncontrolled production of lymphocytes, a type of white blood cell)? 

• Do you have a history of organ or bone marrow transplant? 

• Do you have a history of an infected joint prosthesis or other implanted device with the prosthesis or device still in situ? 

• Do you have any chronic, uncontrolled medical condition other than RA, which would interfere with study participation, such as uncontrolled diabetes, hypertension, morbid obesity, thyroid, adrenal, pulmonary, hepatic, renal, neurologic, or psychiatric disease; or other disease of concern? 

• Have you had a significant blood loss (> 450 mL) or transfusion of any blood/plasma within the past 12 weeks? 

• Have you undergone a major surgery (requiring regional block or general anesthesia) within the last 12 weeks or have planned major surgery during the study? 

• Have you had prior treatment with any investigational drug relating to PD-1 agonism or Participated in any investigational drug/device clinical study within 4 weeks? 

• Have you received any live attenuated vaccine in the past 4 weeks or plan to receive throughout the study?  

Answers Must be YES 

• Are you able to understand and sign a consent form? 

• If female of childbearing potential, do you agree to use one of the following contraceptives from Screening of the study through 135 days after final dose? 

• • Hormonal birth control AND barrier methods such as condoms, spermicides 

• • Oral contraceptives (either combined or progesterone only) 

• • Injectable progesterone 

• • Transdermal contraceptive patch 

• • Contraceptive vaginal ring 

• • IUD, Vasectomy if sole partner 

• • Subdermal contraceptive implant 

• • Bilateral tubal occlusion 

• • Abstinence 

• If female of non-childbearing potential, are you classified as one of the following? 

• • Permanently sterilized: hysterectomy, bilateral oophorectomy, or bilateral salpingectomy OR 

• • Postmenopausal for at least 12months  

• If female, do you agree to refrain from egg donation throughout the study? 

• If male with a female partner of childbearing potential, do you agree to use condoms during treatment and until 135 days after the last dose of study drug, and refrain from sperm donation? 

• Are you able to pass a drug screen test? 

PLEASE NOTE: If you do not see an available appointment, please call  210-714-0067 for availability. 

Transportation may be available. Compensation up to $2,850 is available for time and travel.

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