Lupus Erythematosus, SystemicFicolupus2NCT03063281
Anti-ficolin-2 Autoantibodies in Lupus Nephritis
An observational study of Lupus Erythematosus, Systemic, run by University Hospital, Grenoble.
Trial summary
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies. The prevalence and significance of antibodies against Ficolin-2 have not been yet investigated. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- BIological analysis
- How many people
- 213 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to May 2015
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: SLE patients were studied from medical data files of the Departments of Internal Medicine (Grenoble University Hospital, France) and Nephrology (Conception University Hospital, Marseille, France). For SLE patients, clinical and biological manifestations as well as treatments received and disease activity evaluated using the SLE Disease Activity Index (SLEDAI) at the time of sampling were recorded. SLE patients were divided into subgroups as described in group section.
Who may be able to join
- Age: ≥ 18 years old
- Patients with lupus diagnostic criteria (ACR1997)
Who cannot join
- Pregnant women
- Patient with known evolutive cancer
- 48 healthy patients matched in age and sex with one or several SLE patients
About this study
Official title: Association Between the Presence of Autoantibodies Targeting Ficolin-2 and Active Nephritis in Patients With Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies. The prevalence and significance of antibodies against Ficolin-2 have not been yet investigated. The aims of this study were to determine the prevalence of anti-ficolin-2 antibodies among SLE patients and to investigate their potential as diagnostic and/or prognostic biomarkers in SLE.
This study is a secondary phase of a serum sample analysis done in early 2015 in order to determine the prevalence of anti-ficolin-2 antibodies among the same cohort as the previously declared study (ClinicalTrials.gov ID: NCT02625831; Unique Protocol ID: 1841851v0).
Read more
In this retrospective study, clinical data were obtained from medical files and blood samples were selected from preexisting biological collection. SLE patients (n=165) were informed and did not objected, they were matched to healthy controls (n=48). Disease activity was determined according to the SLEDAI score. Anti-ficolin-2 antibodies levels were measured in sera by ELISA and correlated to previously obtained Anti-ficolin-3, Anti-ficolin-2, anti-dsDNA and anti-C1q antibodies levels.
The titer of anti-ficolin-2 antibodies was correlated with the SLEDAI score (p<0.0001). The presence of anti-ficolin-2 antibodies was associated with anti-ficolin-3 antibodies, anti-C1q and anti-dsDNA antibodies.
Interestingly, the combination of anti-ficolin-3, anti-ficolin-2 and anti-C1q antibodies demonstrated higher specificity than any other traditional biomarker.
These results suggest that anti-ficolin-3 and anti-ficolin-2 antibodies could be useful for the diagnosis of active nephritis in SLE patients.
Read the detailed description
For this retrospective study, the well written brief summary should be sufficient.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- BIological analysis
- Keywords
- ficolin-2, anti-ficolin-2 antibodies, lupus nephritis, Lupus Erythematosus, Systemic, biomarker, ficolin-3, anti-ficolin-3 antibodies
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIological analysisOther
Also called Biological analysis on preexisting
Biological analysis : ficolin-2 et anti-ficolin-2 antibodies
| Study group | Role | What they receive |
|---|---|---|
| SLE patient | 165 SLE patients. Subgroup : 77 with active lupus and 88 in disease remission. in the active subgroup : 36 with lupus nephritis and 41 without. Biological analysis were performed. Receives: Other: BIological analysis | |
| healthy patients | 48 healthy patients. Biological analysis were performed. Receives: Other: BIological analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-ficolin-2 antibodies presence in SLE patients
Anti-ficolin-2 antibodies in SLE patients, considered positive if superior than 95 arbitrary units.
This study have a single visit approach with serum collection so every outcome is measured at T0, which is the only visit for the patient.
Measured: measured at day of inclusion = T0
Secondary outcomes (4)
Correlation of anti-ficolin-2 antibodies with anti-DNA antibodies in SLE patients
Correlation between Anti-ficolin-2 antibodies presence and anti-DNA antibodies presence.
This study have a single visit approach with serum collection so every outcome is measured at T0, which is the only visit for the patient.
Measured: measured at day of inclusion = T0
Correlation of anti-ficolin-2 antibodies with anti-C1q antibodies in SLE patients
Correlation between Anti-ficolin-2 antibodies presence and anti-C1q antibodies presence.
This study have a single visit approach with serum collection so every outcome is measured at T0, which is the only visit for the patient.
Measured: measured at day of inclusion = T0
Correlation of anti-ficolin-2 antibodies with lupus activity (SLEDAI score) in SLE
Correlation between Anti-ficolin-2 antibodies presence and clinical and/or biological evidence of SLE activity according to SLEDAI score (2012).
This study have a single visit approach with serum collection so every outcome is measured at T0, which is the only visit for the patient.
Measured: measured at day of inclusion = T0
Correlation of anti-ficolin-2 antibodies presence with active nephritis in SLE patients
Correlation between Anti-ficolin-2 antibodies presence and clinical and/or biological evidence of active nephritis This study have a single visit approach with serum collection so every outcome is measured at T0, which is the only visit for the patient.
Measured: measured at day of inclusion = T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study startNov 2012
- Primary completionMay 2013
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Marseille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063281
- Sponsor's protocol ID
- 2030950v0
- Acronym
- Ficolupus2
- Status last verified
- Feb 2017
- First submitted
- 21 Feb 2017
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Further analysis of serum collection is ongoing. IPD availability will be decided by the sponsor at completion and publication.
Publications
Kuraya M, Ming Z, Liu X, Matsushita M, Fujita T. Specific binding of L-ficolin and H-ficolin to apoptotic cells leads to complement activation. Immunobiology. 2005;209(9):689-97. doi: 10.1016/j.imbio.2004.11.001.
PubMed 15804047Herrmann M, Voll RE, Zoller OM, Hagenhofer M, Ponner BB, Kalden JR. Impaired phagocytosis of apoptotic cell material by monocyte-derived macrophages from patients with systemic lupus erythematosus. Arthritis Rheum. 1998 Jul;41(7):1241-50. doi: 10.1002/1529-0131(199807)41:73.0.CO;2-H.
PubMed 9663482Liphaus BL, Kiss MH. The role of apoptosis proteins and complement components in the etiopathogenesis of systemic lupus erythematosus. Clinics (Sao Paulo). 2010 Mar;65(3):327-33. doi: 10.1590/S1807-59322010000300014.
PubMed 20360925Orbai AM, Truedsson L, Sturfelt G, Nived O, Fang H, Alarcon GS, Gordon C, Merrill J, Fortin PR, Bruce IN, Isenberg DA, Wallace DJ, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke AE, Aranow CB, Manzi S, Urowitz MB, Gladman DD, Kalunian KC, Costner MI, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, Van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS, Petri M. Anti-C1q antibodies in systemic lupus erythematosus. Lupus. 2015 Jan;24(1):42-9. doi: 10.1177/0961203314547791. Epub 2014 Aug 14.
PubMed 25124676Sato N, Ohsawa I, Nagamachi S, Ishii M, Kusaba G, Inoshita H, Toki A, Horikoshi S, Ohi H, Matsushita M, Tomino Y. Significance of glomerular activation of the alternative pathway and lectin pathway in lupus nephritis. Lupus. 2011 Nov;20(13):1378-86. doi: 10.1177/0961203311415561. Epub 2011 Sep 5.
PubMed 21893562Lacroix M, Dumestre-Perard C, Schoehn G, Houen G, Cesbron JY, Arlaud GJ, Thielens NM. Residue Lys57 in the collagen-like region of human L-ficolin and its counterpart Lys47 in H-ficolin play a key role in the interaction with the mannan-binding lectin-associated serine proteases and the collectin receptor calreticulin. J Immunol. 2009 Jan 1;182(1):456-65. doi: 10.4049/jimmunol.182.1.456.
PubMed 19109177Plawecki M, Lheritier E, Clavarino G, Jourde-Chiche N, Ouili S, Paul S, Gout E, Sarrot-Reynauld F, Bardin N, Boelle PY, Chiche L, Bouillet L, Thielens NM, Cesbron JY, Dumestre-Perard C. Association between the Presence of Autoantibodies Targeting Ficolin-3 and Active Nephritis in Patients with Systemic Lupus Erythematosus. PLoS One. 2016 Sep 15;11(9):e0160879. doi: 10.1371/journal.pone.0160879. eCollection 2016.
PubMed 27631981Tanha N, Pilely K, Faurschou M, Garred P, Jacobsen S. Plasma ficolin levels and risk of nephritis in Danish patients with systemic lupus erythematosus. Clin Rheumatol. 2017 Feb;36(2):335-341. doi: 10.1007/s10067-016-3508-2. Epub 2016 Dec 15.
PubMed 27981461Watanabe H, Saito R, Asano T, Sato S, Iwadate H, Kobayashi H, Ohira H. Serum L-ficolin levels in patients with systemic lupus erythematosus. Mod Rheumatol. 2012 Nov;22(6):899-902. doi: 10.1007/s10165-012-0616-y. Epub 2012 Feb 21.
PubMed 22350641Colliard S, Jourde-Chiche N, Clavarino G, Sarrot-Reynauld F, Gout E, Deroux A, Fougere M, Bardin N, Bouillet L, Cesbron JY, Thielens NM, Dumestre-Perard C. Autoantibodies Targeting Ficolin-2 in Systemic Lupus Erythematosus Patients With Active Nephritis. Arthritis Care Res (Hoboken). 2018 Aug;70(8):1263-1268. doi: 10.1002/acr.23449. Epub 2018 Jun 21.
PubMed 29045037
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between the Presence of Autoantibodies Targeting Ficolin-2 and Active Nephritis in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT03063281
- Acronym / sponsor ID
- Ficolupus2 / 2030950v0
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- ficolin-2, anti-ficolin-2 antibodies, lupus nephritis, Lupus Erythematosus, Systemic, biomarker, ficolin-3, anti-ficolin-3 antibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Hospital, Marseille
- Study start
- Nov 2012 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Feb 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.
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies. The prevalence and significance of antibodies against Ficolin-2 have not been yet investigated. The aims of this study were to determine the prevalence of anti-ficolin-2 antibodies among SLE patients and to investigate their potential as diagnostic and/or prognostic biomarkers in SLE.
This study is a secondary phase of a serum sample analysis done in early 2015 in order to determine the prevalence of anti-ficolin-2 antibodies among the same cohort as the previously declared study (ClinicalTrials.gov ID: NCT02625831; Unique Protocol ID: 1841851v0).
In this retrospective study, clinical data were obtained from medical files and blood samples were selected from preexisting biological collection. SLE patients (n=165) were informed and did not objected, they were matched to healthy controls (n=48). Disease activity was determined according to the SLEDAI score. Anti-ficolin-2 antibodies levels were measured in sera by ELISA and correlated to previously obtained Anti-ficolin-3, Anti-ficolin-2, anti-dsDNA and anti-C1q antibodies levels.
The titer of anti-ficolin-2 antibodies was correlated with the SLEDAI score (p<0.0001). The presence of anti-ficolin-2 antibodies was associated with anti-ficolin-3 antibodies, anti-C1q and anti-dsDNA antibodies.
Interestingly, the combination of anti-ficolin-3, anti-ficolin-2 and anti-C1q antibodies demonstrated higher specificity than any other traditional biomarker.
These results suggest that anti-ficolin-3 and anti-ficolin-2 antibodies could be useful for the diagnosis of active nephritis in SLE patients.
Detailed description
For this retrospective study, the well written brief summary should be sufficient.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLE patient | – | Other: BIological analysis165 SLE patients. Subgroup : 77 with active lupus and 88 in disease remission. in the active subgroup : 36 with lupus nephritis and 41 without. Biological analysis were performed. |
| healthy patients | – | Other: BIological analysis48 healthy patients. Biological analysis were performed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- SLE patients were studied from medical data files of the Departments of Internal Medicine (Grenoble University Hospital, France) and Nephrology (Conception University Hospital, Marseille, France). For SLE patients, clinical and biological manifestations as well as treatments received and disease activity evaluated using the SLE Disease Activity Index (SLEDAI) at the time of sampling were recorded. SLE patients were divided into subgroups as described in group section.
Key inclusion criteria (2 listed)
- Age: ≥ 18 years old
- Patients with lupus diagnostic criteria (ACR1997)
Key exclusion criteria (3 listed)
- Pregnant women
- Patient with known evolutive cancer
- 48 healthy patients matched in age and sex with one or several SLE patients
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 |
|---|---|---|
| BIological analysisAlso: Biological analysis on preexistingBiological analysis : ficolin-2 et anti-ficolin-2 antibodies | Other | SLE patient, healthy patients |
Primary outcome
Anti-ficolin-2 antibodies presence in SLE patients
Time frame: measured at day of inclusion = T0
Anti-ficolin-2 antibodies in SLE patients, considered positive if superior than 95 arbitrary units. This study have a single visit approach with serum collection so every outcome is measured at T0, which is the only visit for the patient.
4 secondary outcomes
Correlation of anti-ficolin-2 antibodies with anti-DNA antibodies in SLE patients
Time frame: measured at day of inclusion = T0
Correlation of anti-ficolin-2 antibodies with anti-C1q antibodies in SLE patients
Time frame: measured at day of inclusion = T0
Correlation of anti-ficolin-2 antibodies with lupus activity (SLEDAI score) in SLE
Time frame: measured at day of inclusion = T0
Correlation of anti-ficolin-2 antibodies presence with active nephritis in SLE patients
Time frame: measured at day of inclusion = T0
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 24 Feb 2017.
- Background: PubMed 15804047Kuraya M, Ming Z, Liu X, Matsushita M, Fujita T. Specific binding of L-ficolin and H-ficolin to apoptotic cells leads to complement activation. Immunobiology. 2005;209(9):689-97. doi: 10.1016/j.imbio.2004.11.001.
- Background: PubMed 9663482Herrmann M, Voll RE, Zoller OM, Hagenhofer M, Ponner BB, Kalden JR. Impaired phagocytosis of apoptotic cell material by monocyte-derived macrophages from patients with systemic lupus erythematosus. Arthritis Rheum. 1998 Jul;41(7):1241-50. doi: 10.1002/1529-0131(199807)41:73.0.CO;2-H.
- Background: PubMed 20360925Liphaus BL, Kiss MH. The role of apoptosis proteins and complement components in the etiopathogenesis of systemic lupus erythematosus. Clinics (Sao Paulo). 2010 Mar;65(3):327-33. doi: 10.1590/S1807-59322010000300014.
- Background: PubMed 25124676Orbai AM, Truedsson L, Sturfelt G, Nived O, Fang H, Alarcon GS, Gordon C, Merrill J, Fortin PR, Bruce IN, Isenberg DA, Wallace DJ, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke AE, Aranow CB, Manzi S, Urowitz MB, Gladman DD, Kalunian KC, Costner MI, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, Van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS, Petri M. Anti-C1q antibodies in systemic lupus erythematosus. Lupus. 2015 Jan;24(1):42-9. doi: 10.1177/0961203314547791. Epub 2014 Aug 14.
- Background: PubMed 21893562Sato N, Ohsawa I, Nagamachi S, Ishii M, Kusaba G, Inoshita H, Toki A, Horikoshi S, Ohi H, Matsushita M, Tomino Y. Significance of glomerular activation of the alternative pathway and lectin pathway in lupus nephritis. Lupus. 2011 Nov;20(13):1378-86. doi: 10.1177/0961203311415561. Epub 2011 Sep 5.
- Background: PubMed 19109177Lacroix M, Dumestre-Perard C, Schoehn G, Houen G, Cesbron JY, Arlaud GJ, Thielens NM. Residue Lys57 in the collagen-like region of human L-ficolin and its counterpart Lys47 in H-ficolin play a key role in the interaction with the mannan-binding lectin-associated serine proteases and the collectin receptor calreticulin. J Immunol. 2009 Jan 1;182(1):456-65. doi: 10.4049/jimmunol.182.1.456.
- Background: PubMed 27631981Plawecki M, Lheritier E, Clavarino G, Jourde-Chiche N, Ouili S, Paul S, Gout E, Sarrot-Reynauld F, Bardin N, Boelle PY, Chiche L, Bouillet L, Thielens NM, Cesbron JY, Dumestre-Perard C. Association between the Presence of Autoantibodies Targeting Ficolin-3 and Active Nephritis in Patients with Systemic Lupus Erythematosus. PLoS One. 2016 Sep 15;11(9):e0160879. doi: 10.1371/journal.pone.0160879. eCollection 2016.
- Background: PubMed 27981461Tanha N, Pilely K, Faurschou M, Garred P, Jacobsen S. Plasma ficolin levels and risk of nephritis in Danish patients with systemic lupus erythematosus. Clin Rheumatol. 2017 Feb;36(2):335-341. doi: 10.1007/s10067-016-3508-2. Epub 2016 Dec 15.
- Background: PubMed 22350641Watanabe H, Saito R, Asano T, Sato S, Iwadate H, Kobayashi H, Ohira H. Serum L-ficolin levels in patients with systemic lupus erythematosus. Mod Rheumatol. 2012 Nov;22(6):899-902. doi: 10.1007/s10165-012-0616-y. Epub 2012 Feb 21.
- Derived from this study: PubMed 29045037Colliard S, Jourde-Chiche N, Clavarino G, Sarrot-Reynauld F, Gout E, Deroux A, Fougere M, Bardin N, Bouillet L, Cesbron JY, Thielens NM, Dumestre-Perard C. Autoantibodies Targeting Ficolin-2 in Systemic Lupus Erythematosus Patients With Active Nephritis. Arthritis Care Res (Hoboken). 2018 Aug;70(8):1263-1268. doi: 10.1002/acr.23449. Epub 2018 Jun 21.
- Individual participant dataSharing planned: Undecided. Further analysis of serum collection is ongoing. IPD availability will be decided by the sponsor at completion and publication.
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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 Lupus Erythematosus, Systemic, run by University Hospital, Grenoble.
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 2 inclusion and 3 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 24 Feb 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?
Anti-ficolin-2 antibodies presence in SLE patients (time frame: measured at day of inclusion = T0). 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 NCT03063281, which also lists 10 linked publications.
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 24 Feb 2017.