A multicenter evaluation of the treatment persistence of advanced therapies (Biological disease-modifying agents and Targeted synthetic Disease Modifying Anti-Rheumatic Drugs) in the treatment of rheumatoid arthritis (RA): A Real World Evidence (RWE) study from India

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  XELJANZ
• Study drug International non-proprietary name (INN) or common name:
  TOFACITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA29) tofacitinib

  tofacitinib
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Short description of the study population:
  Adult patients aged 18 years and over, diagnosed with rheumatoid arthritis eligible for to start treatment with advanced therapies (biological and targeted synthetic disease modifying anti-rheumatic drugs). ; Patients who have started treatment with disease modifying anti-rheumatic drugs for longer than 3 months cannot be included in this study.
• 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)
• Estimated number of subjects:
  225

Study design details

• Study design:
  This is a multicenter prospective study conducted in India to evaluate treatment persistence and drug survival on advanced therapies in rheumatoid arthritis. ; All assessments described in this protocol are performed as part of normal clinical practice for the patient population.
• Main study objective:
  Treatment persistence and drug survival in patients on the advanced therapies for rheumatoid arthritis.
• Setting:
  The patients would be enrolled based on the inclusion and exclusion criteria. The treatment regimen will be as per treating physician (investigators) decision. ; Routine clinical and diagnostic evaluations will be as per standard practice guidelines, irrespective of whether the patient is participating in the study or not.
• Comparators:
  NA
• Outcomes:
  The percentage of patients in each class, achieving 1 year survival will be calculated. 100% of the study population considered as all patients who entered the study. ; Effectiveness parameters, as the change in Disease activity score 28, Health Assessment Questionnaire disability index and psoriatic arthritis disease activity scores from baseline to the end of the study. ; Number of adverse events while on treatment during the study inclusion. ; Disease factors or other determinants for treatment switch and time to first and subsequent switch to advanced therapies.
• Data analysis plan:
  In the statistical analysis plan the clinical profile of the patients will be summarized by mean ± Standard Deviation and frequency (%) respectively. ; Demographic parameters will be reported by suitable measure of average like mean or median if continuous otherwise frequency and percentage. ; Median drug survival/ drug persistency will be compared across demographic parameters and external validity will be assessed by log-rank test. ; Mean ± Standard of the score efficacy parameters will also be reported and compared across demographic parameters, external validity will be tested by independent t-test and ANOVA or Mann-Whitney and Kruskal Wallis test. ; Adverse event and severity of advance event will also be compared if many across demographic parameters by percentage with 95% confidence interval.