IgG4-related DiseaseG4-FHNCT02899039
Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease
A study testing extra blood draw samples in people with IgG4-related Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
IgG4-related disease is a rare and very recently identified pathology, whose frequency is certainly underestimated. The clinical presentation varies among affected organs, and most often, patients have at least three organ damage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IgG4-related Disease
- What is being tested?
- extra blood draw samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2012to 7 May 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- IgG4-related disease patients or
- Sjogren syndrome patients or
- Healthy subjects
Who cannot join
- Presence of autoimmune or inflammatory associated disease
- Age less than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
IgG4-related disease is a rare and very recently identified pathology, whose frequency is certainly underestimated.
The clinical presentation varies among affected organs, and most often, patients have at least three organ damage.
Read more
These organs exhibit tissue infiltration mononuclear polymorphic cells with often severe fibrosis progression resulting in a loss of function.
The biomarker, though not specific, is a polyclonal elevated serum IgG4, and histological marker, currently held by several teams, is the presence within the inflammatory infiltrate, of a predominance of IgG4-expressing plasma-cells with a relative plasma-cells IgG4 + / IgG +> 50% on tissue immunostaining.
The investigators project provides a global assessment of T lymphocyte abnormalities and specifically the TFH (Follicular Helper) during this IgG4-related disease compared to so-called groups "control" subjects suffering from Sjogren syndrome or healthy subjects.
- Conditions
- IgG4-related Disease
- Being tested
- extra blood draw samples
- Medical subject headings
- Immunoglobulin G4-Related Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extra blood draw samplesBiological
| Study group | Role | What they receive |
|---|---|---|
| IgG4-related disease | Experimental | Subjects suffering from IgG4-related disease Receives: Biological: extra blood draw samples |
| Sjögren syndrome | Active comparator | Subjects suffering from Sjôgren syndrome Receives: Biological: extra blood draw samples |
| Healthy controls | Active comparator | Healthy subjects Receives: Biological: extra blood draw samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start17 Jul 2012
- Primary completion4 May 2015
- Study completion7 May 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 IgG4-related DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle Desalbres, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899039
- Sponsor's protocol ID
- 2011-31
- Other IDs
- RC12_3608
- Acronym
- G4-FH
- Status last verified
- Sep 2016
- First submitted
- 2 Sep 2016
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
De Sainte Marie B, Urban ML, Vely F, Seguier J, Grados A, Daniel L, Ebbo M, Schleinitz N. Pathophysiology of IgG4-related disease: A T follicular helper cells disease? Presse Med. 2020 Apr;49(1):104013. doi: 10.1016/j.lpm.2020.104013. Epub 2020 Mar 29.
PubMed 32234383
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular Helper T Cells: Biological Marker and Involvement in the Physiopathology of the IgG4-related Disease
- ClinicalTrials.gov ID
- NCT02899039
- Acronym / sponsor ID
- G4-FH / 2011-31
- Conditions
- IgG4-related Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 17 Jul 2012
- Primary completion
- 4 May 2015 (actual)
- Study completion
- 7 May 2016 (actual)
- First posted
- 13 Sep 2016 (estimated)
- 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.
IgG4-related disease is a rare and very recently identified pathology, whose frequency is certainly underestimated.
The clinical presentation varies among affected organs, and most often, patients have at least three organ damage.
These organs exhibit tissue infiltration mononuclear polymorphic cells with often severe fibrosis progression resulting in a loss of function.
The biomarker, though not specific, is a polyclonal elevated serum IgG4, and histological marker, currently held by several teams, is the presence within the inflammatory infiltrate, of a predominance of IgG4-expressing plasma-cells with a relative plasma-cells IgG4 + / IgG +> 50% on tissue immunostaining.
The investigators project provides a global assessment of T lymphocyte abnormalities and specifically the TFH (Follicular Helper) during this IgG4-related disease compared to so-called groups "control" subjects suffering from Sjogren syndrome or healthy subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IgG4-related disease | Experimental | Biological: extra blood draw samplesSubjects suffering from IgG4-related disease |
| Sjögren syndrome | Active comparator | Biological: extra blood draw samplesSubjects suffering from Sjôgren syndrome |
| Healthy controls | Active comparator | Biological: extra blood draw samplesHealthy subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IgG4-related disease patients or
- Sjogren syndrome patients or
- Healthy subjects
Key exclusion criteria (2 listed)
- Presence of autoimmune or inflammatory associated disease
- Age less than 18 years
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 |
|---|---|---|
| extra blood draw samples | Biological | Healthy controls, IgG4-related disease, Sjögren syndrome |
Primary outcome
Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood
Time frame: 36 months
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 8 May 2026.
- Results publication: PubMed 32234383De Sainte Marie B, Urban ML, Vely F, Seguier J, Grados A, Daniel L, Ebbo M, Schleinitz N. Pathophysiology of IgG4-related disease: A T follicular helper cells disease? Presse Med. 2020 Apr;49(1):104013. doi: 10.1016/j.lpm.2020.104013. Epub 2020 Mar 29.
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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.
Urielle Desalbres study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extra blood draw samples in people with IgG4-related Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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: finished, as of the sponsor's last update on 8 May 2026. 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 France. 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?
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?
Proportion of Follicular Helper T cells (CD4 + CXCR5 + ICOShigh) in the blood (time frame: 36 months). 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 NCT02899039, 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 8 May 2026.