Corrona PsA-SpA Registry Questionnaire Based observational Research Study
One of the following:
Diagnosed with psoriatic arthritis (PsA) and initiating (prescribed or starting) an eligible medication for the treatment of PsA at the enrollment visit.
Meet the modified New York classification criteria for ankylosing spondylitis (AS) and initiating (prescribed or starting) and eligible biologic for the treatment of AS at the enrollment visit.
Meet the ASAS criteria for axial Spondyloarthritis (AxSpa), radiographic or non-radiographic, and initiating (prescribed or starting) and eligible biologic for the treatment of AxSpA at the enrollement visit.
At least 18 years of age or older
Able and willing to provide written consent
Diagnosed with rheumatoid arthritis, systemic lupus erythematosus, or any other form of autoimmune inflammatory arthritis
Participating or plan to participate in a clinical trial with an investigational research study of a non-marketed or marketed investigational drug (e.g. phase I-IV clinical drug trial, post marketing study, registry study where drug is being provided). Of note: concurrent participation in another observational registry study is not excluded.
A Randomized, PC, DB, Phase 2 Study to Assess the Efficacy and Safety of Multiple Doses of BMS-986165 (TyK2 Inhibitor) for Active PsA
- Diagnosed with PsA for at least 6 months before screening, and who meet the (CASPAR) at screening.
- BIOLOGIC NAÏVE, or have failed or been intolerant to 1 TNF-inhibitor (30% of study participants).
- At least one ≥ 2 cm lesion of plaque psoriasis at screening.
- Minimum of ≥ 3 swollen joints and ≥ 3 tender joints (66/68 joint counts).
- hsCRP ≥ 3mg/L at screening.
- If on a conventional non-biologic DMARD (i.e., MTX, leflunomide, sulfasalazine or hydroxychloroquine) can only take 1 DMARD.
- Have any contraindications to a TNF inhibitor.
- Prior exposure to Stelara, or any IL-17 inhibitor like Cosentyx or Taltz.
- History of active infection (bacterial, fungal or viral), tuberculosis, or of an unstable clinical condition (e.g., renal, hepatic, GI, CV, RESP, PSYCH, immune, hematologic, etc.).
- Have a history of VTE (DVT/PE) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE).
- “Active” fibromyalgia.
ADVANTAGE FOR PATIENTS
- Placebo arm 1/3 for only 16 weeks, then all participants get active drug PO
- Study treatment can last as long as one year.