Phase 1b/2 Study of IV Sarilumab in Adult With RA

Korábbi kezelés

• Any prior (within the defined periods below) or concurrent use of immunosuppressive:
  • Janus kinase (JAK) inhibitor (eg, tofacitinib) within 4 weeks of baseline.
  • Cell-depletion agents (eg, anti CD20) without evidence of recovery of B cells to baseline level.
  • Anakinra within 1 week of baseline.
  • Abatacept within 8 weeks of baseline.
  • Tumor necrosis factor (TNF) inhibitors within 2 to 8 weeks.
  • Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline.
  • Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.
• Therapeutic failure, including inadequate response or intolerance, or contraindication, to biological IL-6 antagonist (prior IL-6 antagonist treatment that was terminated for reasons unrelated to therapeutic failure at least 3 months before baseline is not exclusionary).
• Unstable methotrexate (MTX) dose (if participant is on concomitant MTX).
• Concurrent use of systemic corticosteroids (CS) of more than 10 mg/day.
• History of prior articular or prosthetic joint infection.
• History of inflammatory bowel disease or severe diverticulitis or previous gastrointestinal perforation.
• History of juvenile idiopathic arthritis or arthritis onset prior to age 16.

Más betegség

• Exclusion related to tuberculosis (TB): active TB or a history of incompletely treated TB regardless of screening Quantiferon® result.
• History of invasive opportunistic infections, including but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, aspergillosis despite resolution or John Cunningham virus (progressive multifocal leukoencephalopathy).
• Uncontrolled diabetes mellitus.
• Prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, non-metastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the baseline visit.
• Severe systemic RA, including but not limited to vasculitis, pulmonary fibrosis, and/or Felty's syndrome.
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Egyéb

• Pregnant or breastfeeding woman.

• Participant must be 18 years old or the legal age of consent in the jurisdiction in which the study is taking place or older, at the time of signing the informed consent.
• Diagnosis of RA, according to the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) 2010 RA Classification Criteria with ≥3 months disease duration.
• ACR Class I to III functional status, based on the 1991 revised criteria
• Moderate-to-severely active RA, defined as: DAS28-ESR\>3.2.
• Inability to continue treatment with a RA DMARD approved for first line use because of intolerance or inadequate response.
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.