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GSK - ContRAst Clinical Research Study

A 52-week, Phase 3, Multicentre, Randomised, Double-Blind, Efficacy, and Safety Study Comparing GSK3196165 With Placebo and With Tofacitinib, in Combination With Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

GSK - ContRAst Clinical Research Study
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Benefits

Patient Benefits

Patients who screen and then enroll in the study will receive:

  • Study drug (active, comparator or placebo), lab work, visits are included at no cost.
  • Patients will be reimbursed $50.00 per completed study visit for transport costs with a maximum benefit of $2,900 for the course of the study.

Study Duration

Study Duration for Patients

The total study duration is approximately 64-weeks which consists of approximately 15 visits during the course of the study.

Study Drug

GSK3196165

GSK3196165 is an investigational biologic medication.

Eligibility

Inclusion Criteria

The following must be met in order to qualify for the study.

  • ≥18 years of age
  • Has had RA for ≥6 months and was not diagnosed before 16 years of age
  • Has active disease, as defined by having both:*
    • ≥6/68 tender/painful joints (TJC), and
    • ≥6/66 swollen joints (SJC)
  • Has at least 1 bone erosion present on hand/wrist or foot radiographs
  • Has had an inadequate response to MTX, despite currently taking MTX 15-25 mg/week** oral or injected
    • If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.
      • A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement.

Exclusion Criteria

Patients with any of the following are ineligible to enroll in the study.

  • Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
  • Has received prior treatment with an antagonist of GM-CSF or its receptor or targeted synthetic DMARDs (either experimental or approved), including Janus kinase (JAK) inhibitors
  • Has received prior treatment with a biologic DMARD that was discontinued due to an inadequate response

** 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.

Study Location

600 Aviator Ct.
Vandalia, OH 45377

See if you Qualify!

Complete the form below and a research coordinator will contact you regarding phone or in-person pre-screening.

or Call Us!

1-833-STAT-833

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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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