"Corticoid-16" in Long Term When Administered Systemically in Patients in Routine Medical Practice
Condition: Pharmacological Action
Study type: Observational [Patient Registry]

Summary: 
      Evaluation of pharmacokinetic parameters of diprospan in long term when administered
      systemically in patients in routine medical practice.

      Applied research project.

      Design: open-comparative prospective cohort study.

      Two groups of subjects:

        -  patients who are receiving diprospan in standard therapy of their existing disease, or
           multiple times, but following the introduction of diprospan is planned no earlier than
           28 days after the first,

        -  control group of subjects for the study of pharmacokinetic parameters diprospan and its
           metabolites.

      Objectives of the study: to evaluate the pharmacokinetic parameters of Diprospan in the long
      term when administered systemically in patients in routine practice.
    

Detailed description: 
      Design: Open-comparative prospective cohort study.

      The study population: two groups of subjects

        -  first group: patients who are receiving diprospan in standard therapy of their existing
           disease, or multiple times, but following the introduction of diprospan is planned no
           earlier than 28 days after the first administration.

        -  second group: the control group of subjects for the study of pharmacokinetic parameters
           diprospan and its metabolites.

      Intramuscular injection diprospan (suspension for injection) at a dose of 1 ml (7 mg) once.

      Main objective of the study: to evaluate pharmacokinetic parameters of Diprospan in the long
      term when administered systemically in patients in routine practice.

      Objectives of the study:

        -  to develop laboratory analytical method of quantifying the investigated substance
           (betamethasone) in human urine sensitive, selective and precise method using high
           performance liquid chromatography with tandem mass selective detection,

        -  analysis of quantitative content, evaluation of pharmacokinetic parameters of diprospan
           in the bioassay in patients with systemic intramuscular application in routine clinical
           practice in the Russian Federation,

        -  analysis of clinical patient data and pharmacokinetic parameters of study drug in the
           urine of patients,

        -  determination of minimum number of arbitration bioassay to store,

        -  preparation of recommendations for systemic use of glucocorticoids in athletes, in
           accordance with the requirements of the all-Russian anti-doping rules and the
           requirements of the anti-doping rules, approved by the international anti-doping
           authorities.

      First group (patients receiving diprospan).

      Stage 1: selection of study participants from a number of patients who are administered with
      Diprospan" at a dose of 1 ml (7 mg) intramuscularly as standard therapy of existing disease,
      or multiple times, but following introduction of "Diprospan" drug is planned no earlier than
      28 days after the first.

      Step 2: draw the original samples for pharmacokinetic studies, a single injection of the
      study medication as part of routine care.

      Stage 3: Sampling in dynamics for pharmacokinetic studies; assessment of clinical and
      laboratory parameters after a single administration of the study drug.

      Stage 4: evaluation of clinical examination data and pharmacokinetic study.

      Second group (control).

      Stage 1: selection of study participants from a number of patients or healthy volunteers who
      had not received systemic or local corticosteroids in the last 12 weeks before the screening
      visit.

      Stage 2: drawing of samples for pharmacokinetic studies.

      Primary endpoints:

      • betamethasone concentration in urine.

      Secondary endpoints:

        -  evaluation of articular status,

        -  overall assessment of the health status of the patient,

        -  overall assessment of disease activity, physician assessment of disease activity
           criteria for SDAI, CDAI, DAS-28.

      Number of patients.

      First group (the study of the pharmacokinetics of the drug "Diprrospan"): at least 20
      patients (10 men and 10 women).

      The second group (control): at least 20 patients (10 men and 10 women).

      Safety monitoring In accordance with the order of the Health Ministry of Russia №757n
      "Approval of the Procedure for monitoring the safety of medicinal products for medical use,
      registration of adverse events, serious adverse reactions, unexpected adverse reactions in
      the use of drugs for medical use."
    

Intervention name(s): Diprospan
Intervention type(s): Drug
Intervention description(s): Intramuscular
Other intervention name(s): Betamethasone
Intervention MeSH terms: Betamethasone; Betamethasone dipropionate, betamethasone sodium phosphate drug combination
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of both sexes aged 18 to 35 years old Caucasian,

          -  verified diagnosis of rheumatoid arthritis according to criteria ACR \ EULAR 2010 or
             ankylosing spondylitis (axial spondyloarthritis) ASAS criteria for 2009 based on the
             data a detailed medical history, a standard clinical, laboratory and instrumental
             methods of examination.
      
Biospecimen description: 
      Urine