Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Evaluation of patient-reported outcomes

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

This is an international, non-interventional, observational, prospective, multicentre study evaluating the effectiveness of Krka’s etoricoxib in patients with rheumatic diseases (osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis) according to the investigator’s consideration and in compliance with SmPC of Krka’s etoricoxib. Only patients, who would have been otherwise also treated with Krka’s etoricoxib in local regular clinical practice, were enrolled in this international non-interventional study. Also, only patients who agreed with informed consent form and consent for statistical evaluation of personal data were included in the study. This protocol did not influence the decision of attending physician regarding patient management. Any diagnostic method or therapeutic decision made by a physician were independent from the inclusion of a patient in the study in accordance with its non-interventional design.
Study drug and medical condition

Name of medicine, other

Krka's etoricoxib

Study drug International non-proprietary name (INN) or common name

ETORICOXIB

Anatomical Therapeutic Chemical (ATC) code

(M01AH05) etoricoxib
etoricoxib

Medical condition to be studied

Pain
Osteoarthritis
Rheumatoid arthritis
Population studied

Short description of the study population

Patients with symptomatic rheumatic diseases (osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis) who were indicated for treatment with etoricoxib and obtained Krka’s etoricoxib according SmPC and who agreed with informed consent form and consent for statistical evaluation of personal data, were included in the study.

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
Study design details

Study design

observational, prospective, non-interventional, international, multicentre

Main study objective

Evaluate the real-world effectiveness of Krka’s etoricoxib, assessing pain intensity of rheumatic disease patients, investigate the advantages of a single-dose regimen, evaluate gastrointestinal tolerability and cardiovascular safety, focusing also on patients with knee osteoarthritis.

Outcomes

- Primary outcome:
o Assessing the mean absolute and relative reduction of pain intensity on VAS scale in patients with rheumatic diseases from 1st till 2nd data capture and separately for naïve and previously treated patients.
o Assessing proportion of patients with rheumatic diseases with clinically meaningful improvement of pain management (reduction of pain intensity is considered as clinically meaningful, if pain intensity does not exceed 30 mm on VAS or if the baseline intensity is reduced for at least 50%) at 2nd data capture and separately for naive and previously treated patients.
o Assessing the mean absolute improvement of five outcomes (pain, symptoms, function in daily living, sport and recreation function, knee-related quality of life) with KOOS questionnaire in patients with knee osteoarthritis from 1st till 2nd data capture and separately for naïve and previously treated patients.

- The secondary endpoints encompass 12 items realted with: previous teatments with rheumatic agents and/or analgesics, evaluation of reasons for discontinuing previous treatment with NSAIDs, evaluation of patient’s and investigator’s satisfaction with the Krka’s etoricoxib treatment, assessing cardiovascular safety of treatment with Krka's etoricoxib, satisfcation with Krka's etoricoxib dosign regimen, assessing proportion of patients with gastrointestinal problems, assessing proportion of patients who need in addition to Krka's etoricoxib treatment with other rheumatic agent/analgesic, assessing average time till the first follow-up, evaluating Krka's etoricoxib average dose and daily dose, assessing proportion of patients with comorbidities, evaluation of reasons for Krka's etoricoxib change at 2nd data capture, assessing the proportion of patient who experienced improvement in KOOS values, safety evaluation.

Data analysis plan

The study characteristics of the protocol were entered into electronic data capture system - the eCRF application. All data and clinical information were collected in accordance with the country specific privacy laws, Helsinki declaration, protocol and regular clinical practice. Corrections made in eCRF by the investigator were captured in audit trail log along. In case of missing, misleading or incomplete data during the study conductance, the monitor produced queries. Queries were forwarded to investigator’s clarification. Only investigator or authorized study personnel could provide data change or data correction. The statistical report includes standard descriptive statistics. For numerical variables and each group in question, the largest and the smallest value in the associated sample, the sample mean and the sample standard deviation, were recorded. For categorical variables and each group in question, the numeri and percentages of the categories present are listed. All patients included in the study are also included in the safety analysis. Two-sided confidence intervals are computed individually at level of confidence 95 % (by inversion, this corresponds to hypothesis tests with simple null hypothesis, possibly with nuisance parameters, and two-sided alternatives at level of significance 5 %). In this study, only the full analysis set is considered.

Summary results

Part of separate document “Summary of results”.