Rheumatoid PolyarthritisNCT04505982
Anti IL6R Reduce Complement Serum Level in Rheumatoid Arthritis Patients: Facts and Implications
An observational study of Rheumatoid Polyarthritis, run by BADOT, Valerie at 1 site in Belgium.
Trial summary
Interleukin 6 is identified as a cytokine with pro and anti-inflammatory effects, depending on the context to which it is exposed, exerting a role in the expansion and activation of T lymphocytes, in the survival, expansion and the maturation of B lymphocytes and plasmablasts as well as in the regulation of the acute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Polyarthritis
- What is being tested?
- Data extraction from medical files
- Type of treatment
- Injection or infusion
- How many people
- 35 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jul 2020to Dec 2020
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients followed in the CHU Brugmann Hospital for a rhumatoid polyarthiritis and treated according to standard of care with tocilizumab / sarilumab or for which this treatment is about to be initiated, in intravenous or subcutaneous form
Who may be able to join
- Patient ≥ 18 years old
- Regular follow-up at CHU Brugmann Hospital for confirmed rheumatoid arthritis and meeting the ACR 2010 criteria
- On tocilizumab / sarilumab or for which this treatment is about to be initiated, in intravenous or subcutaneous form
Who cannot join
- Patients with a known complement deficiency before their rheumatic pathology
- Patient with hepatic impairment
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Brugmann University Hospital
Brussels, 1020
Tracy Vandergraesen, MD, Tracy.VANDERGRAESEN@chu-brugmann.be
Tracy Vandergraesen, MD
About this study
Official title: Anti IL6R Reduce Complement Serum Level in Rheumatoid Arthritis Patients: Facts and Implications: Monocentric Study in Belgian Center
Interleukin 6 is identified as a cytokine with pro and anti-inflammatory effects, depending on the context to which it is exposed, exerting a role in the expansion and activation of T lymphocytes, in the survival, expansion and the maturation of B lymphocytes and plasmablasts as well as in the regulation of the acute phase response. The IL-6 receptor complex is a dimer in which each monomer is composed of an 80 kD subunit, IL-6R or CD126, expressed in hepatocytes, leukocytes and in megakaryocytes, which binds IL- 6 and a 130 kD subunit, gp130 or CD130, which is expressed ubiquitously. Its effects are mediated mainly by the way of tyrosine kinases of the Jaks family, and transcription factors of the STATs family.
The complement system is made up of a set of plasma proteins, cascading through three activation pathways (classical, alternate and lectin pathway). This system is considered part of innate immunity. It is also part of the acute phase response.The complement has several functions: cell lysis by formation of the membrane attack complex; opsonization and activation of phagocytosis of foreign particles, elimination of circulating immune complexes, and regulation of the adaptive immunity response and inflammation via anaphylatoxins.
Read more
After reviewing the literature, the link between IL6 and the complement system can be summarized as an induction of factor C3 and factor B, but also probably CD55 (DAF or Decay acceleration factor) and CD59 (MAC-IP or MAC-Inhibitory Protein) by interleukin-6. The effects of IL-6 on the lectin pathway, on the other hand, seem contradictory: inhibition or induction of the synthesis of MASP1 / 3 and 2 depending on the experimental model.
It has become common knowledge that anti-IL6 receptor monoclonal antibodies, used in the treatment of patients with rheumatoid arthritis and other inflammatory conditions, reduce the serum levels of acute phase proteins and in particular the levels of CRP. But what about other acute phase proteins and in particular the complement ?
A recent study showed that the serum levels of the complement components C3 and C4 were also reduced after the use of tocilizumab and this as early as 4 weeks after the first administration. To the investigator's knowledge, this is the only study reporting a decrease in complement during treatment with anti-IL6R.
This study would allow the evaluation of complement parameters in the population of patients under treatment with antiIL6R (tocilizumab or sarilumab) within the CHU Brugmann Hospital in order to
- confirm or not this observation
- look for a possible secondary clinical consequence
- compare this decrease with the activity of the disease in order to see if it could be a marker of effectiveness
- put this decrease in parallel with the side effects / tolerance of the treatment in order to see if it could be a marker of toxicity / safety
This study will also investigate the subpopulations of B lymphocytes (memory B, transitional B, and plasmablasts) in order to assess whether the evolution of one of these lines would be predictive of a therapeutic response.
Secondly, this study would eventually allow
- to improve the understanding of the mechanisms of action of the treatment on inflammatory markers by evaluating the activity of the residual complement
- to raise the need to find new parameters for monitoring inflammatory activity in these patients, since CRP assays are not very helpful.
- Conditions
- Rheumatoid Polyarthritis
- Being tested
- Data extraction from medical files
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extraction from medical filesOther
Data extraction from medical files
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab intravenous | Patients followed in the CHU Brugmann Hospital for a rheumatoid polyarthritis and treated according to standard of care with tocilizumab, intravenous Receives: Other: Data extraction from medical files | |
| Tocilizumab subcutaneous | Patients followed in the CHU Brugmann Hospital for a rheumatoid polyarthritis and treated according to standard of care with tocilizumab, subcutaneous Receives: Other: Data extraction from medical files | |
| Sarilumab subcutaneous | Patients followed in the CHU Brugmann Hospital for a rheumatoid polyarthritis and treated according to standard of care with sarilumab, subcutaneous Receives: Other: Data extraction from medical files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data
Age, sex
Measured: 5 minutes
Body Mass Index
Body Mass Index
Measured: 5 minutes
Medical History (descriptive listing)
Medical History (descriptive listing)
Measured: 5 minutes
Neoplasia
Active neoplasia, or neoplasia dated less than 5 years
Measured: 5 minutes
Disease Activity Score Calculator for Rheumatoid Arthritis- DAS28VS
The DAS28 is a measure of disease activity in rheumatoid arthritis . DAS stands for 'disease activity score' and the number 28 refers to the 28 joints that are examined in this assessment. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
Measured: 5 minutes
Disease Activity Score Calculator for Rheumatoid Arthritis- DAS28CRP
The DAS28 is a measure of disease activity in rheumatoid arthritis . DAS stands for 'disease activity score' and the number 28 refers to the 28 joints that are examined in this assessment. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
Measured: 5 minutes
Health Assessment Questionnaire (HAQ)
The Health Assessment Questionnaire Disability Index (HAQ) is developed for the assessment of disability in patients with Rheumatoid Arthritis. It focuses on two dimensions of health status, physical disability (eight categories), and pain. The eight categories review a total of 20 specific functions and evaluate patient's difficulty with activities of daily living over the past week.
Measured: 5 minutes
Concomitant medication (descriptive listing)
Concomitant medication (descriptive listing)
Measured: 5 minutes
Adverse events linked to the medication (descriptive listing)
Adverse events linked to the medication (descriptive listing)
Measured: 5 minutes
Hemogram: normal (yes/no)
A hemogram contains all of the pertinent information required for assessment of hematopoiesis as well as a visual assessment of plasma appearance and measurement of total solids (an estimate of total protein) in plasma.
Measured: 5 minutes
Leukocyte count
Leukocyte count
Measured: 5 minutes
Blood Ionogram: normal (yes/no)
The blood ionogram analyses the ionic composition of the blood
Measured: 5 minutes
Renal function: normal (yes/no)
Renal function
Measured: 5 minutes
Hepatic function: normal (yes/no)
Hepatic function
Measured: 5 minutes
Parathyroid hormone count
Parathyroid hormone count
Measured: 5 minutes
Vitamin D count
Vitamin D count
Measured: 5 minutes
Lipid balance: normal (yes/no)
Lipid balance allows monitoring of cholesterol (LDL-cholesterol and HDL-cholesterol) and triglycerides
Measured: 5 minutes
Glucose concentration in the blood
Glucose concentration in the blood
Measured: 5 minutes
Rheumatoid factor concentration
Rheumatoid factor is an autoantibody that induces inflammation and damage to the joints.
Measured: 5 minutes
AntiCCP antibodies count
The detection of anti-CCP antibodies is used to help diagnose and prognosticate rheumatoid arthritis and differentiate it from other types of arthritis
Measured: 5 minutes
FAN count
FAN are autoantibodies against elements of the nucleus
Measured: 5 minutes
Sedimentation rate
Sedimentation rate
Measured: 5 minutes
CRP count
CRP count
Measured: 5 minutes
Complement fraction C1q count
Complement fraction C1q count
Measured: 5 minutes
Complement fraction C3 count
Complement fraction C3 count
Measured: 5 minutes
Complement fraction C3d count
Complement fraction C3d count
Measured: 5 minutes
Complement fraction C3a count
Complement fraction C3a count
Measured: 5 minutes
Complement fraction C4 count
Complement fraction C4 count
Measured: 5 minutes
Complement fraction C4a count
Complement fraction C4a count
Measured: 5 minutes
Complement fraction CH50 count
Complement fraction CH50 count
Measured: 5 minutes
Complement fraction FB count
Complement fraction FB count
Measured: 5 minutes
Lectin count
Lectin count
Measured: 5 minutes
Lectin complement pathway serine protease 2 (MASP-2) count
Lectin complement pathway serine protease 2 (MASP-2) count
Measured: 5 minutes
Mannose Binding lectin (MBL) count
Mannose Binding lectin (MBL) count
Measured: 5 minutes
Complement SC5b9 count
Complement SC5b9 count
Measured: 5 minutes
Fibrinogen count
Fibrinogen count
Measured: 5 minutes
Lymphocyte B count: memory cells
Lymphocyte B count: memory cells
Measured: 5 minutes
Lymphocyte B count: transitional cells
Lymphocyte B count: transitional cells
Measured: 5 minutes
Lymphocyte B count: plasmablast cells
Lymphocyte B count: plasmablast cells
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start14 Jul 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid PolyarthritisStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BADOT, Valerie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, BADOT, Valerie, Brugmann University Hospital
- Investigators
- Tracy Vandergraesen, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505982
- Sponsor's protocol ID
- CHUB-IL6
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti IL6R Reduce Complement Serum Level in Rheumatoid Arthritis Patients: Facts and Implications: Monocentric Study in Belgian Center
- ClinicalTrials.gov ID
- NCT04505982
- Acronym / sponsor ID
- CHUB-IL6
- Conditions
- Rheumatoid Polyarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- BADOT, ValerieUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Aug 2020 (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.
Interleukin 6 is identified as a cytokine with pro and anti-inflammatory effects, depending on the context to which it is exposed, exerting a role in the expansion and activation of T lymphocytes, in the survival, expansion and the maturation of B lymphocytes and plasmablasts as well as in the regulation of the acute phase response. The IL-6 receptor complex is a dimer in which each monomer is composed of an 80 kD subunit, IL-6R or CD126, expressed in hepatocytes, leukocytes and in megakaryocytes, which binds IL- 6 and a 130 kD subunit, gp130 or CD130, which is expressed ubiquitously. Its effects are mediated mainly by the way of tyrosine kinases of the Jaks family, and transcription factors of the STATs family.
The complement system is made up of a set of plasma proteins, cascading through three activation pathways (classical, alternate and lectin pathway). This system is considered part of innate immunity. It is also part of the acute phase response.The complement has several functions: cell lysis by formation of the membrane attack complex; opsonization and activation of phagocytosis of foreign particles, elimination of circulating immune complexes, and regulation of the adaptive immunity response and inflammation via anaphylatoxins.
After reviewing the literature, the link between IL6 and the complement system can be summarized as an induction of factor C3 and factor B, but also probably CD55 (DAF or Decay acceleration factor) and CD59 (MAC-IP or MAC-Inhibitory Protein) by interleukin-6. The effects of IL-6 on the lectin pathway, on the other hand, seem contradictory: inhibition or induction of the synthesis of MASP1 / 3 and 2 depending on the experimental model.
It has become common knowledge that anti-IL6 receptor monoclonal antibodies, used in the treatment of patients with rheumatoid arthritis and other inflammatory conditions, reduce the serum levels of acute phase proteins and in particular the levels of CRP. But what about other acute phase proteins and in particular the complement ?
A recent study showed that the serum levels of the complement components C3 and C4 were also reduced after the use of tocilizumab and this as early as 4 weeks after the first administration. To the investigator's knowledge, this is the only study reporting a decrease in complement during treatment with anti-IL6R.
This study would allow the evaluation of complement parameters in the population of patients under treatment with antiIL6R (tocilizumab or sarilumab) within the CHU Brugmann Hospital in order to
- confirm or not this observation
- look for a possible secondary clinical consequence
- compare this decrease with the activity of the disease in order to see if it could be a marker of effectiveness
- put this decrease in parallel with the side effects / tolerance of the treatment in order to see if it could be a marker of toxicity / safety
This study will also investigate the subpopulations of B lymphocytes (memory B, transitional B, and plasmablasts) in order to assess whether the evolution of one of these lines would be predictive of a therapeutic response.
Secondly, this study would eventually allow
- to improve the understanding of the mechanisms of action of the treatment on inflammatory markers by evaluating the activity of the residual complement
- to raise the need to find new parameters for monitoring inflammatory activity in these patients, since CRP assays are not very helpful.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab intravenous | – | Other: Data extraction from medical filesPatients followed in the CHU Brugmann Hospital for a rheumatoid polyarthritis and treated according to standard of care with tocilizumab, intravenous |
| Tocilizumab subcutaneous | – | Other: Data extraction from medical filesPatients followed in the CHU Brugmann Hospital for a rheumatoid polyarthritis and treated according to standard of care with tocilizumab, subcutaneous |
| Sarilumab subcutaneous | – | Other: Data extraction from medical filesPatients followed in the CHU Brugmann Hospital for a rheumatoid polyarthritis and treated according to standard of care with sarilumab, subcutaneous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients followed in the CHU Brugmann Hospital for a rhumatoid polyarthiritis and treated according to standard of care with tocilizumab / sarilumab or for which this treatment is about to be initiated, in intravenous or subcutaneous form
Key inclusion criteria (3 listed)
- Patient ≥ 18 years old
- Regular follow-up at CHU Brugmann Hospital for confirmed rheumatoid arthritis and meeting the ACR 2010 criteria
- On tocilizumab / sarilumab or for which this treatment is about to be initiated, in intravenous or subcutaneous form
Key exclusion criteria (2 listed)
- Patients with a known complement deficiency before their rheumatic pathology
- Patient with hepatic impairment
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 |
|---|---|---|
| Data extraction from medical filesData extraction from medical files | Other | Sarilumab subcutaneous, Tocilizumab intravenous, Tocilizumab subcutaneous |
Primary outcome
Demographic data
Time frame: 5 minutes
Age, sex
Body Mass Index
Time frame: 5 minutes
Body Mass Index
Medical History (descriptive listing)
Time frame: 5 minutes
Medical History (descriptive listing)
Neoplasia
Time frame: 5 minutes
Active neoplasia, or neoplasia dated less than 5 years
Disease Activity Score Calculator for Rheumatoid Arthritis- DAS28VS
Time frame: 5 minutes
The DAS28 is a measure of disease activity in rheumatoid arthritis . DAS stands for 'disease activity score' and the number 28 refers to the 28 joints that are examined in this assessment. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
Disease Activity Score Calculator for Rheumatoid Arthritis- DAS28CRP
Time frame: 5 minutes
The DAS28 is a measure of disease activity in rheumatoid arthritis . DAS stands for 'disease activity score' and the number 28 refers to the 28 joints that are examined in this assessment. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
Health Assessment Questionnaire (HAQ)
Time frame: 5 minutes
The Health Assessment Questionnaire Disability Index (HAQ) is developed for the assessment of disability in patients with Rheumatoid Arthritis. It focuses on two dimensions of health status, physical disability (eight categories), and pain. The eight categories review a total of 20 specific functions and evaluate patient's difficulty with activities of daily living over the past week.
Concomitant medication (descriptive listing)
Time frame: 5 minutes
Concomitant medication (descriptive listing)
Adverse events linked to the medication (descriptive listing)
Time frame: 5 minutes
Adverse events linked to the medication (descriptive listing)
Hemogram: normal (yes/no)
Time frame: 5 minutes
A hemogram contains all of the pertinent information required for assessment of hematopoiesis as well as a visual assessment of plasma appearance and measurement of total solids (an estimate of total protein) in plasma.
Leukocyte count
Time frame: 5 minutes
Leukocyte count
Blood Ionogram: normal (yes/no)
Time frame: 5 minutes
The blood ionogram analyses the ionic composition of the blood
Renal function: normal (yes/no)
Time frame: 5 minutes
Renal function
Hepatic function: normal (yes/no)
Time frame: 5 minutes
Hepatic function
Parathyroid hormone count
Time frame: 5 minutes
Parathyroid hormone count
Vitamin D count
Time frame: 5 minutes
Vitamin D count
Lipid balance: normal (yes/no)
Time frame: 5 minutes
Lipid balance allows monitoring of cholesterol (LDL-cholesterol and HDL-cholesterol) and triglycerides
Glucose concentration in the blood
Time frame: 5 minutes
Glucose concentration in the blood
Rheumatoid factor concentration
Time frame: 5 minutes
Rheumatoid factor is an autoantibody that induces inflammation and damage to the joints.
AntiCCP antibodies count
Time frame: 5 minutes
The detection of anti-CCP antibodies is used to help diagnose and prognosticate rheumatoid arthritis and differentiate it from other types of arthritis
FAN count
Time frame: 5 minutes
FAN are autoantibodies against elements of the nucleus
Sedimentation rate
Time frame: 5 minutes
Sedimentation rate
CRP count
Time frame: 5 minutes
CRP count
Complement fraction C1q count
Time frame: 5 minutes
Complement fraction C1q count
Complement fraction C3 count
Time frame: 5 minutes
Complement fraction C3 count
Complement fraction C3d count
Time frame: 5 minutes
Complement fraction C3d count
Complement fraction C3a count
Time frame: 5 minutes
Complement fraction C3a count
Complement fraction C4 count
Time frame: 5 minutes
Complement fraction C4 count
Complement fraction C4a count
Time frame: 5 minutes
Complement fraction C4a count
Complement fraction CH50 count
Time frame: 5 minutes
Complement fraction CH50 count
Complement fraction FB count
Time frame: 5 minutes
Complement fraction FB count
Lectin count
Time frame: 5 minutes
Lectin count
Lectin complement pathway serine protease 2 (MASP-2) count
Time frame: 5 minutes
Lectin complement pathway serine protease 2 (MASP-2) count
Mannose Binding lectin (MBL) count
Time frame: 5 minutes
Mannose Binding lectin (MBL) count
Complement SC5b9 count
Time frame: 5 minutes
Complement SC5b9 count
Fibrinogen count
Time frame: 5 minutes
Fibrinogen count
Lymphocyte B count: memory cells
Time frame: 5 minutes
Lymphocyte B count: memory cells
Lymphocyte B count: transitional cells
Time frame: 5 minutes
Lymphocyte B count: transitional cells
Lymphocyte B count: plasmablast cells
Time frame: 5 minutes
Lymphocyte B count: plasmablast cells
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Tracy Vandergraesen, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Polyarthritis, run by BADOT, Valerie at 1 site in Belgium.
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 3 inclusion and 2 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 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Tracy Vandergraesen, MD (003224754508, Tracy.VANDERGRAESEN@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic data (time frame: 5 minutes). The study lists 39 primary outcomes in all. 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 10 Aug 2020.