A study assessing the use of GOlimumab in current clinical PRACTICE and its impact on patients with chronic inflammatory arthritis (MK-8259-020) (GO-PRACTICE)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multicenter, prospective, national (France) study

Study drug and medical condition

• Name of medicine:
  SIMPONI
• Medical condition to be studied:
  Rheumatoid arthritis

  Psoriatic arthropathy

  Ankylosing spondylitis

Population studied

• Short description of the study population:
  Adult patients diagnosed with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) were recruited successively upon initial golimumab prescription, as per routine clinical practice. The patients were treated as per each center’s standard practice. The decision to treat was at the physician’s discretion, and had to be made prior to the patient’s inclusion in the study.; ; Inclusion Criteria; 1. Patients aged 18 years or older.; 2. Patients having given their verbal consent to participate in the study, after having received verbal and written information about the study.; 3. Patients diagnosed with a chronic rheumatic inflammatory disease.; 4. Patient with an initial hospital prescription for golimumab but who did not yet initiate golimumab treatment.; 5. Patients capable of understanding and completing the PRO questionnaires.; ; Exclusion Criteria; 1. Patients who were previously treated with golimumab and/or stopped golimumab before inclusion; 2. Patients who had participated in previous studies of golimumab.; 3. Patients who had already started golimumab treatment prior to the inclusion visit and/or who were receiving golimumab at the time of the inclusion visit.; 4. Conditions or situations that, in the opinion of the investigator, limited the patient’s ability to fully participate in the study or to fulfil study requirements,
• 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:
  Immunocompromised
• Estimated number of subjects:
  750

Study design details

• Main study objective:
  The primary objective of this study is to assess the persistence of golimumab treatment 24 months after the initial prescription in adult patients with chronic inflammatory rheumatic diseases, in routine clinical practice in France.
• Outcomes:
  The primary outcome measure of this study is the overall proportion of patients persisting with golimumab treatment 24 months after the initial prescription. The secondary outcomes include 1) to describe the therapeutic strategy including prior to treatments, prescription pattern of golimumab in routine clinical practice with the dose, regimen, and co-prescriptions, respect of contraindications and reasons for golimumab withdrawal, 2) to describe treated patients, 3) to assess golimumab persistence at 1 year, and 4) to assess the safety profile.
• Data analysis plan:
  The primary endpoint is the overall proportion of patients persisting with golimumab treatment at 2 years after the initial prescription, using standard descriptive statistics. Sensitivity analyses will be provided using the following assumptions: 1) All patients lost to follow-up at 2 years have discontinued definitively golimumab (worst hypothesis), 2) All patients lost to follow-up at 2 years are continuing treatment with golimumab at 2 years (best hypothesis).

Documents

Study results

MK-8259-020-CSR_Final Redaction