Last updated on November 2019

Patient-Reported Outcomes In Rheumatoid Arthritis Patients Treated With Tofacitinib Or Biological Disease-Modifying Antirheumatic Drugs (DMARDs) In Real Life Conditions

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Rheumatoid Arthritis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Patients 18 years of age at the time of recruitment
  • Patient diagnosed with moderate to severe RA 6 months before enrollment
  • Patients who have had an inadequate response to the continuous use of methotrexate or combination of conventional DMARDs for at least 12 weeks before the study without dose change within the last 8 weeks before enrollment in the study
  • Patients with no biological DMARDs use in patient history.
  • Patients prescribed with tofacitinib or biological DMARDs in the last two weeks at doses established in ACR guidelines published in 2015 and following medical criteria.
  • Acceptance for patients to participate in the study and signing of the informed consent.

Exclusion Criteria:

  • Patients who do not have the ability to answer the questionnaires by themselves or who have any kind of mental disorder that may affect their answers.
  • Patients diagnosed with autoimmune rheumatic diseases other than RA and Sjogren's syndrome.
  • Patients treated with biological DMARDs in monotherapy.
  • Participation in other studies involving investigational drug(s) (Phases 1-4) within 4 weeks or 5 half-lives (whichever is longer) after discontinuation of the investigational compound before the current study begins and/or during study participation.
  • Patients with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
  • Patients with lymphoproliferative disorders (e.g., Epstein Barr Virus (EBV) related lymphoproliferative disorder), a history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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