Clinical Research Programs
Corrona RA Questionnaire Based Research Observational Research Stud
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
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.
A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis
- Have a diagnosis of adult-onset RA
- At least 3/28 tender joints, and at least 3/28 swollen joints
- at Visits 1 and 2
- Inadequate response or intolerance to at least 1 DMARD
- (biologic or synthetic)
- If RA < 6 months, OK to enroll if patient is RF or CCP+ at screening
- Have at least 1 of the following 4 characteristics:
- Documented evidence of a VTE prior to this study
- Age ≥60 years
- BMI >30 kg/m2
- Age 50 to <60 years AND BMI 25 to <30 kg/m2
- Have any contraindications to a TNF inhibitor
- Have a history of VTE (DVT/PE) within 12 weeks prior to randomization
- OR have a history of recurrent (>1) VTE (DVT/PE)
- Treatment with MORE THAN 1 PRIOR TNFi that was d/c for inadequate response for RA or intolerance (AE)
- Treatment with >2 cDMARDs
- Treatment with ANY JAK inhibitor
- Treatment with any anticoagulant (ASA, Plavix OK)
- Active recurrent malignancy <5 years prior to randomization (except cervical CA and nonmelanoma skin cancer/NMSC)
- Patients will receive active drug regardless of randomization
- Study participation lasts between 2.5 and 5.5 years
To Learn more about the RA Bridge Study, contact Kate 610-868-1336 ext. 113
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.
- 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.
- 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).
- $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.