"Corticoid-16" in Long Term When Administered Systemically in Patients in Routine Medical Practice

NCT03119454 | Completed DMC

• 1 other identifier: RU-FANO-10-16
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pharmacological Action

Outcome Measures

Primary Outcomes (1)

• Betamethasone concentration in urine

  Quantitative determination of study drug (betamethasone) in human urine should be conducted sensitive, selective and precise method using high performance liquid chromatography with tandem mass selective detection (HPLC-MS / MS) with a detection mode permits fragment ions not more R \<70K. laboratory analytical method should be developed for the measurement of betamethasone with the definition of the limit of not less than 7.5 ng / mL.

  Day 28

Secondary Outcomes (6)

• Articular status (swelling)

  Day 28

• Articular status (pain)

  Day 28

• Physician's assessment of disease activity

  Day 28

• Simple disease activity index SDAI

  Day 28

• Clinical disease activity index CDAI

  Day 28

Other Outcomes (2)

• Overall assessment of the health status of the patient by physician

  Day 28

• Overall assessment of the health status of the patient by patient

  Day 28

Study Arms (2)

Patients receiving diprospan

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.

Drug: Diprospan

Control subjects

Patients or healthy volunteers who had not received systemic or local corticosteroids in the last 12 weeks before the screening visit.

Interventions

Diprospan DRUG

Intramuscular

Also known as: Betamethasone

Patients receiving diprospan

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Signed a voluntary informed consent form,
• 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,
• The presence of signs of active inflammation according to standard valuation techniques (for rheumatoid arthritis or DAS28 ≥3.2 CDAI≥10; for ankylosing spondylitis or BASDAI≥2.0 ASDAS≥1.3),
• If the patient gets authorized for use in the study antirheumatic drugs (except glucocorticoids other) for treatment of the underlying disease, they should be applied in stable doses for at least six weeks before the screening visit.
• BMI should be in the range of 18.0 to 30.0 kg / m 2 ,
• Consent to use adequate methods of contraception to patients during the study period.

You may not qualify if:

• Allergic history,
• Drug intolerance, hypersensitivity to any of the components "Diprospan" drug,
• Severe chronic cardiovascular, bronchopulmonary, endocrine and nervous systems (including mental) and diseases of the gastrointestinal tract (GIT), liver, kidney, blood, surgical procedures on the gastrointestinal tract (except appendectomy)
• Acute infectious, non-infectious and allergic diseases in less than 4 weeks prior to visit 1,
• A positive blood test for HIV, syphilis, hepatitis B and C,
• Systolic blood pressure measured at rest after 5 minutes of exposure in the "sitting" position, below 100 mm Hg. or above 140 mm Hg and / or diastolic blood pressure below 60 mm Hg or above 90 mm Hg,
• Heart rate below 40 beats / min,
• Hemoglobin \<90 g / l (9 g / dl), or hematocrit less than 30%,
• White blood cells \<3.0 x 10 9 / L,
• Absolute neutrophil count (ANC) \<1.0 x 10 / L,
• Serum creatinine more than 0.132 mmol / L,
• Increased ALT and / or AST 1.5 upper limit of normal,
• Clinically significant (in the opinion of the investigator) ECG changes,
• The use of systemic or local corticosteroids for the treatment of the underlying disease for the last 12 weeks before the screening visit,
• Taking any medications, in addition to permissible under study

Sponsors & Collaborators

• Federal State Budgetary Scientific Institution, Scientific Research Institute of Rheumatology: lead
• Institute of Biomedical Chemistry, Russia: collaborator
• The League of Clinical Research, Russia: collaborator

Related Publications (1)

• Kopylov AT, Novikov AA, Kaysheva AL, Vykhodets IT, Karateev DE, Zgoda VG, Lisitsa AV. Quantitative assessment of betamethasone dual-acting formulation in urine of patients with rheumatoid arthritis and ankylosing spondylitis after single-dose intramuscular administration and its application to long-term pharmacokinetic study. J Pharm Biomed Anal. 2018 Feb 5;149:278-289. doi: 10.1016/j.jpba.2017.11.021. Epub 2017 Nov 6.

  PMID: 29128828 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Interventions

betamethasone dipropionate, betamethasone sodium phosphate drug combination; Betamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: April 18, 2017
• Study Start: October 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 18, 2017

Record last verified: 2016-12