Canadian Non-Interventional Study of Xeljanz in Rheumatoid Arthritis (CANTORAL)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational, multi-centre study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA29) tofacitinib

  tofacitinib
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Short description of the study population:
  Patients aged 18 years or older diagnosed with rheumatoid arthritis (RA) treated with tofacitinib.; Inclusion Criteria:; 1. Adult patients, at least 18 years of age or older at the time of recruitment.; 2. Diagnosis with RA as per the revised 1987 American College of Rheumatology (ACR) criteria or 2010 ACR/EULAR criteria.; 3. Patients for whom the treating physician has made the decision to commence tofacitinib treatment in accordance with the Canadian Product Monograph.; 4. Initiation of treatment with tofacitinib within 28 days from study enrolment.; 5. Acceptance for patients to participate in the study and the signing of the informed consent.; ; Exclusion Criteria:; 1. Patients who do not have the ability answer the questionnaires by themselves or who have any kind of disorder that may affect their answers.; 2. Patients diagnosed with autoimmune rheumatic diseases other than RA.; 3. Cannot or will not sign informed consent.; 4. Active participation or enrollment in an interventional trial.; 5. Previous experience with tofacitinib through either a clinical trial or previous treatment.; 6. Is not expected to be available for follow up assessments as required for adequate management.; 7. According to the judgment of the physician will not be able to participate in the study including the presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of RA.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with rheumatoid arthritis
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  1) To describe the profile of RA patients initiating treatment with tofacitinib in the Canadian real – world/clinical setting. 2) To describe the clinical effectiveness of tofacitinib over time in patients with moderate to severe RA in the real-world/clinical setting.
• Outcomes:
  The primary outcome variable of the study will be the Clinical Disease Assessment Index (CDAI). Tender Joint Count, Swollen Joint Count, DAS28, SDAI, Physician Global Assessment of Disease Activity, Patient Global Assessment of Disease Activity, Patient Subjective Assessment of Pain, Health Assessment Questionnaire Disability Index, Routine Assessment of Patient Index Data-3, EuroQol, Work Productivity and Activity Impairment: Treatment Satisfaction, Fatigue, Health Resource Utilization
• Data analysis plan:
  The analyses conducted for the study will be predominantly descriptive with several associations assessed with bivariate and multivariate methods. However, given that there are no specific a-priori defined hypotheses being tested, there is no need for multiplicity correction for the number of associations tested and the number of outcomes assessed. Hence any p-values presented should be considered as descriptive statistics themselves, and, there will be no declarations of statistical significance. The analyses will be conducted on observed cases without imputation for missing data in order to preserve the observational nature of the study. The Full Analysis Set (FAS) will be comprised of all enrolled patients providing consent to participate in the study. Nevertheless, the use of mixed effects models will help to compensate for missing observations, patient attrition and unequal time intervals between assessments.

Documents

Study results

A3921280 Non Interventional Study Report Abstract 01 May 2023_Redacted

Study report

A3921280 Non Interventional Study Report 01 May 2023_Redacted (2)

Study, other information

A3921280_NON-INTERVENTIONAL STUDY ABSTRACT v4.0_19Jan2022