Pharmacological ActionNCT03119454
"Corticoid-16" in Long Term When Administered Systemically in Patients in Routine Medical Practice
An observational study of Pharmacological Action, run by Federal State Budgetary Scientific Institution, Scientific Research Institute of Rheumatology.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacological Action
- What is being tested?
- Diprospan
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Dec 2016
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 20Show fewer
- 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
- Plasmapheresis in less than 14 days prior to study entry,
- Participation in a clinical trial of an unregistered in the Russian Federation of a drug or device for less than 3 months prior to the study,
- The inability or unwillingness of the patient to comply with the conditions of the study program,
- Any reason for that, according to the researcher, will prevent the participation of the patient in the study,
- Pregnant or lactating women (all women should have a negative pregnancy test on the day of screening).
About this study
Official title: Evaluation of Pharmacokinetic Parameters of "Diprospan"
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.
Read the 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."
- Conditions
- Pharmacological Action
- Being tested
- Diprospan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiprospanDrug
Also called Betamethasone
Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Secondary outcomes (6)
Articular status (swelling)
Number of swollen joints
Measured: Day 28
Articular status (pain)
Number of painful joints
Measured: Day 28
Physician's assessment of disease activity
Visual analogue scale, mm
Measured: Day 28
Simple disease activity index SDAI
Scale: remission; low activity; moderate activity; high activity
Measured: Day 28
Clinical disease activity index CDAI
Scale: remission; low activity; moderate activity; high activity
Measured: Day 28
Disease activity score DAS28
Scale: remission; low activity; moderate activity; high activity
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study startOct 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pharmacological ActionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution, Scientific Research Institute of Rheumatology
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Biomedical Chemistry, Russia, The League of Clinical Research, Russia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119454
- Sponsor's protocol ID
- RU-FANO-10-16
- Status last verified
- Dec 2016
- First submitted
- 9 Dec 2016
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29128828
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacokinetic Parameters of "Diprospan"
- ClinicalTrials.gov ID
- NCT03119454
- Acronym / sponsor ID
- RU-FANO-10-16
- Conditions
- Pharmacological Action
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal State Budgetary Scientific Institution, Scientific Research Institute of RheumatologyUniversity, hospital or other
- Collaborators
- Institute of Biomedical Chemistry, Russia, The League of Clinical Research, Russia
- Study start
- Oct 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving diprospan | – | Drug: DiprospanPatients 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. |
| Control subjects | – | –Patients or healthy volunteers who had not received systemic or local corticosteroids in the last 12 weeks before the screening visit. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiprospanAlso: BetamethasoneIntramuscular | Drug | Patients receiving diprospan |
Primary outcome
Betamethasone concentration in urine
Time frame: Day 28
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.
6 secondary outcomes
Articular status (swelling)
Time frame: Day 28
Articular status (pain)
Time frame: Day 28
Physician's assessment of disease activity
Time frame: Day 28
Simple disease activity index SDAI
Time frame: Day 28
Clinical disease activity index CDAI
Time frame: Day 28
Disease activity score DAS28
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Derived from this study: PubMed 29128828Kopylov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacological Action, run by Federal State Budgetary Scientific Institution, Scientific Research Institute of Rheumatology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Betamethasone concentration in urine (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03119454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.