Elevated Level of IFN Type I in SLE PatientsNCT05446428
Evaluation of Type I IFN Level and Disease Activity in SLE Patients
An observational study of Elevated Level of IFN Type I in SLE Patients, run by V.A. Nasonova Research Institute of Rheumatology, Moscow.
Trial summary
Elevated level of IFN type I in SLE patients associated with certain serum biomarkers (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Elevated Level of IFN Type I in SLE Patients
- What is being tested?
- study of IFNGS expression biomarkers
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 31 Jul 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 70 adult patients with SLE who receive inpatient or outpatient саre from 01.06.2022 (1 stage) 30 of them with moderate to severe disease activity (SLEDAI 2К ≥6) will be included in prospective observation (2 stage 01.06.2022-25.12.2023)
Who may be able to join
- Age 18-60 years old
- Patients with SLE (SLICC/ACR 2012) confirmed by rheumatologist
- Provided written informed consent before any study-related procedures are performed.
- Ability to attend scheduled visits
- No positive changes in the course of standard of care SLE therapy (glucocorticoids in stable doses, hydroxychloroquine and/or immunosuppressant therapy) at least 30 days before screening.
Who cannot join
- Participation in any other clinical study
- Pregnancy or pregnancy planning in next 12 months, lactation
- Acute infectious disease or relapse of chronic infectious disease.
- Receiving any of biologic agent or Janus-kinases inhibitors during 24 months prior to screening.
- Active severe or unstable neuropsychiatric SLE manifestations (convulsion, psychosis, delirium, hallucinations, coma, transverse myelitis).
Trial locations and contacts
No sites are listed yet.
Tatiana Panafidina, MD contact
About this study
Elevated level of IFN type I in SLE patients associated with certain serum biomarkers (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α, TNF-RII, BAFF, APRIL), clinical and laboratory manifestations, activity and duration pf the disease and SLE patients quality of life. Standard immunosuppressive and anti-B-cell therapy can reduce the IFN type I and associated biomarkers levels in patients with high and moderate disease activity (SLEDAI-2К ≥6).
- Being tested
- study of IFNGS expression biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study of IFNGS expression biomarkersOther
Blood tests for serum biomarkers, autoantibodies, cytokine profile etc.
| Study group | Role | What they receive |
|---|---|---|
| Any SLE Disease Activity | Not described Receives: Other: study of IFNGS expression biomarkers | |
| Moderate to severe SLE Disease Activity | Not described Receives: Other: study of IFNGS expression biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathogenetic, clinical and prognostic significance of IFN stimulated genes expression - IFNGS biomarkers in SLE patients
Pathogenetic, clinical and prognostic significance of IFN stimulated genes expression - IFNGS biomarkers (IFI44L, MX1, IFIT 1, RSAD2, EPSTI1), serum biomarkers (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α), TNF-α receptors type II (TNF-RII), В-cell activation factors (BAFF, APRIL) in SLE patients.
Measured: Sept 1 2022 - Nov 1 2022
Secondary outcomes (3)
Rate of IFN stimulated genes
Rate of IFN stimulated genes hyper-expression, serum biomarkers level (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α), TNF-α receptors type II level (TNF-RII), В-cell activation factors level (BAFF, APRIL) in SLE patient's blood.
Measured: Nov 1 2022 - Oct 31 2024
IFN stimulated genes hyper-expression and serum biomarkers level
IFN stimulated genes hyper-expression and serum biomarkers level (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α), TNF-α receptors type II level (TNF-RII), В-cell activation factors level (BAFF, APRIL) associated with SLE clinical and laboratory manifestations (such as muco-cutaneous, joints, renal, hematological, immunological et ctr.), disease activity (assessed with SLEDAI-2k) and duration, patients' quality of life.
Measured: Nov 1 2022 - Oct 31 2024
IFNGS
IFNGS alone or as a part of complex poly-parametric indexes is a predictor of standard immunosuppressive and anti-B-cell therapy effectiveness in SLE and flares prevention.
Measured: Nov 1 2022 - Oct 31 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Level of IFN Type I in SLE PatientsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- V.A. Nasonova Research Institute of Rheumatology, Moscow
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Popkova Tatiana, V.A. Nasonova Research Institute of Rheumatology, Moscow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446428
- Sponsor's protocol ID
- D3461L00006
- Status last verified
- Jun 2022
- First submitted
- 30 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Type I IFN Level and Disease Activity in SLE Patients
- ClinicalTrials.gov ID
- NCT05446428
- Acronym / sponsor ID
- D3461L00006
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- V.A. Nasonova Research Institute of Rheumatology, MoscowUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 6 Jul 2022 (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.
Elevated level of IFN type I in SLE patients associated with certain serum biomarkers (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α, TNF-RII, BAFF, APRIL), clinical and laboratory manifestations, activity and duration pf the disease and SLE patients quality of life. Standard immunosuppressive and anti-B-cell therapy can reduce the IFN type I and associated biomarkers levels in patients with high and moderate disease activity (SLEDAI-2К ≥6).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Any SLE Disease Activity | – | Other: study of IFNGS expression biomarkers |
| Moderate to severe SLE Disease Activity | – | Other: study of IFNGS expression biomarkers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 70 adult patients with SLE who receive inpatient or outpatient саre from 01.06.2022 (1 stage) 30 of them with moderate to severe disease activity (SLEDAI 2К ≥6) will be included in prospective observation (2 stage 01.06.2022-25.12.2023)
Key inclusion criteria (5 listed)
- Age 18-60 years old
- Patients with SLE (SLICC/ACR 2012) confirmed by rheumatologist
- Provided written informed consent before any study-related procedures are performed.
- Ability to attend scheduled visits
- No positive changes in the course of standard of care SLE therapy (glucocorticoids in stable doses, hydroxychloroquine and/or immunosuppressant therapy) at least 30 days before screening.
Key exclusion criteria (5 listed)
- Participation in any other clinical study
- Pregnancy or pregnancy planning in next 12 months, lactation
- Acute infectious disease or relapse of chronic infectious disease.
- Receiving any of biologic agent or Janus-kinases inhibitors during 24 months prior to screening.
- Active severe or unstable neuropsychiatric SLE manifestations (convulsion, psychosis, delirium, hallucinations, coma, transverse myelitis).
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 |
|---|---|---|
| study of IFNGS expression biomarkersBlood tests for serum biomarkers, autoantibodies, cytokine profile etc. | Other | Any SLE Disease Activity, Moderate to severe SLE Disease Activity |
Primary outcome
Pathogenetic, clinical and prognostic significance of IFN stimulated genes expression - IFNGS biomarkers in SLE patients
Time frame: Sept 1 2022 - Nov 1 2022
Pathogenetic, clinical and prognostic significance of IFN stimulated genes expression - IFNGS biomarkers (IFI44L, MX1, IFIT 1, RSAD2, EPSTI1), serum biomarkers (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α), TNF-α receptors type II (TNF-RII), В-cell activation factors (BAFF, APRIL) in SLE patients.
3 secondary outcomes
Rate of IFN stimulated genes
Time frame: Nov 1 2022 - Oct 31 2024
IFN stimulated genes hyper-expression and serum biomarkers level
Time frame: Nov 1 2022 - Oct 31 2024
IFNGS
Time frame: Nov 1 2022 - Oct 31 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Individual participant dataSharing planned: No
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.
Tatiana Panafidina, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Elevated Level of IFN Type I in SLE Patients, run by V.A. Nasonova Research Institute of Rheumatology, Moscow.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Popkova, MD (+79859988552, popkovatv@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathogenetic, clinical and prognostic significance of IFN stimulated genes expression - IFNGS biomarkers in SLE patients (time frame: Sept 1 2022 - Nov 1 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2022.