Clinical Research Programs

Rheumatoid Arthritis

Corrona RA Questionnaire Based Research Observational Research Stud

Inclusion Criteria

Male or Female, at least 18 years of age

Able and willing to provide written consent for participation in the RA registry

Willing and able to provide Protected Health Information (PHI) which includes the following types of personal information at a minimum: 1)Full name and 2) DOB

Diagnosis of rheumatoid arthritis by a rheumatologist and meet one or more of the following criteria:

*Currently receiving an Eligible Medication** that was started within 365 days of the Enrollment Visit.

*Prescribed or receiving the first dose of an Eligible Medication** on the day of the Enrollment Visit.       

*Diagnosed with RA within 365 days of the Enrollment Visit regardless of treatment regimen

Exclusion Criteria

Diagnosed with Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PSA), Spondyloarthritis(SPA), Ankylosing Spondylitis (AS), Systemic Lupus Erythematosus (SLE), or any other form of auto-immune inflammatory arthritis.

Participation in or planning to participate in a double-blind randomized clinical trial   of an RA drug. Of note, concurrent participation in another observational registry or unblinded Phase 3b/4 trial is not excluded.

                  

Vectra InVolved Informed Decision Outcome Study (VIVID)

A prospective randomized controlled trial evaluating the effect of guided care with Vectra compared to treatment as usual in patients with rheumatoid arthritis.

Inclusion Criteria:

  • Age 18 or older at patient’s screening visit.
  • Diagnosed with RA according to 1987 or 2010 criteria of the American College of Rheumatology.
  • Taking one or more non-biologic or biologic DMARDs at screening and for at least the 3 months prior to screening.
  • The visit at which screening will be conducted was scheduled as part of the patient’s routing care.
  • Patient and/or physician are willing to consider a treatment change.
  • However, no established plan for or expectation of imminent treatment change exist prior to or at the screening/baseline visit.

Exclusion Criteria:

  • Currently taking an anti-IL-6R drug (e.g. tocilizumab, sarilumab)
  • Any contraindication, administrative barrier, or financial limitation that prevents treatment with one new biologic of JAKi therapy for RA
  • An active infection
  • History of malignancy within the past 5 years or any current evidence of persistent malignancy except skin cancer, OR cervical carcinoma treated or excised with a curative procedure.
  • Current enrollment in another clinical trial (registries may be an exception).

Benefits:

  • $50 patient stipend per study visit (3 visit minimum required).
  • Three Vectra Tests over the course of the study at no cost.
  • Hands, wrists and feet x-rays taken at the screening/baseline visit and again at the end of the study (12 month visit) at no cost.

Study to Accelerate Information of Molecular Signatures (AIMS) in Rheumatoid Arthritis

(SCIPHER-RA-003)

An observational, multi-center study to collect baseline and long-term clinical and molecular (genetic) information

from patients with rheumatoid arthritis (RA)

This new precision medicine study’s goal is to collect and store data from people with RA, who have or will be completing the PrismRA® blood test as part of their regular care or treatment.  The PrismRA test predicts the chance that someone with RA will not respond appropriately to anti-Tumor Necrosis Factors (“anti-TNFs”), an established type of biologic therapy.  The study plans to enroll approximately 10,000 people in the US.

Inclusion Criteria:

•  Patient is 18 years of age, or older (≥18) at time of consent

•  Patient has a documented diagnosis of RA

•  Patient has already completed the PrismRA blood test or is intending to complete the PrismRA test

•  The subject must sign an IRB-approved written informed consent with HIPAA language before starting any study-related procedures

•  The subject must be willing and able to comply with all study procedures and the visit schedule, with no expectation of imminent treatment change prior to or at the screening/baseline visit

Exclusion Criteria:

•  Patients who are unable to understand the study’s requirements and/or unable to provide informed consent

•  Patients who do not want and/or are not scheduled for the PrismRA test

Benefits:

•   $50 patient stipend per study visit and there is no cost to you to participate

•   Just six visits over the course of two years

•   There is no direct benefit from participating in this study, but the study results might help researchers to better understand RA, create treatment strategies and/or create new tests to help others in the future