IgG4-related DiseaseNCT01670695
A Prospective Cohort Study of IgG4RD in China
An observational study of IgG4-related Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is an cohort study to investigate the disease course and treatment response of patients with IgG4-related disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IgG4-related Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with newly diagnosed IgG4-related disease.
Who may be able to join
- Males and females
- Age 18-75 years old with informed consent
- Patients with IgG4-RD:
- swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
- elevated serum IgG4 (>1.35 g/L)
- histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);
- exclusion of other diseases.
Who cannot join
- Females planning to bear a child recently or with childbearing potential
- Concurrent severe and/or uncontrolled and/or unstable diseases
- Patient with malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Deptment of Rheumatology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Wen Zhang, MD, 86-10-69158795, zhangwen91@sina.com
Hua Chen, MD, 86-10-69158797, chen77hua@gmail.com
About this study
Official title: Cohort Study of Patients With IgG4-Related Disease
This is an cohort study to investigate the disease course and treatment response of patients with IgG4-related disease.
Read the detailed description
Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and elevated serum IgG4 concentration.
In this study, patients with IgG4-RD will be investigated, including clinical presentation, laboratory findings and imaging study. All patients will be treated by standard care and follow-uped for at least 6 months.
- Conditions
- IgG4-related Disease
- Keywords
- IgG4-related disease, IgG4-RD
- 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.
| Study group | Role | What they receive |
|---|---|---|
| IgG4-RD | Patients with IgG4-RD, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis (Mikulicz disease and Küttner's tumor), inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response
Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2032 (estimated)
- Study completionJan 2032 (estimated)
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 Peking Union Medical College HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Zhang, Peking Union Medical College Hospital
- Investigators
- Wen Zhang, MD, Principal investigator, Deptment of Rheumatology, Peking Union Medical College HospitalFengchun Zhang, Study chair, Deptment of Rheumatology, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670695
- Sponsor's protocol ID
- IgG4RD-Cohort
- Status last verified
- Apr 2017
- First submitted
- 16 Aug 2012
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Luo X, Peng Y, Zhang P, Li J, Liu Z, Lu H, Zhang X, Zeng X, Zhang F, Fei Y, Zhang W. Comparison of the Effects of Cyclophosphamide and Mycophenolate Mofetil Treatment Against Immunoglobulin G4-Related Disease: A Retrospective Cohort Study. Front Med (Lausanne). 2020 Jul 7;7:253. doi: 10.3389/fmed.2020.00253. eCollection 2020.
PubMed 32733900
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Patients With IgG4-Related Disease
- ClinicalTrials.gov ID
- NCT01670695
- Acronym / sponsor ID
- IgG4RD-Cohort
- Conditions
- IgG4-related Disease
- Keywords
- IgG4-related disease, IgG4-RD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jan 2032 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 22 Aug 2012 (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.
This is an cohort study to investigate the disease course and treatment response of patients with IgG4-related disease.
Detailed description
Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and elevated serum IgG4 concentration.
In this study, patients with IgG4-RD will be investigated, including clinical presentation, laboratory findings and imaging study. All patients will be treated by standard care and follow-uped for at least 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IgG4-RD | – | –Patients with IgG4-RD, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis (Mikulicz disease and Küttner's tumor), inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with newly diagnosed IgG4-related disease.
Key inclusion criteria (7 listed)
- Males and females
- Age 18-75 years old with informed consent
- Patients with IgG4-RD:
Key exclusion criteria (3 listed)
- Females planning to bear a child recently or with childbearing potential
- Concurrent severe and/or uncontrolled and/or unstable diseases
- Patient with malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Response
Time frame: 6 months
Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Derived from this study: PubMed 32733900Luo X, Peng Y, Zhang P, Li J, Liu Z, Lu H, Zhang X, Zeng X, Zhang F, Fei Y, Zhang W. Comparison of the Effects of Cyclophosphamide and Mycophenolate Mofetil Treatment Against Immunoglobulin G4-Related Disease: A Retrospective Cohort Study. Front Med (Lausanne). 2020 Jul 7;7:253. doi: 10.3389/fmed.2020.00253. eCollection 2020.
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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.
Wen Zhang, MD principal investigator
Deptment of Rheumatology, Peking Union Medical College Hospital
Fengchun Zhang study chair
Deptment of Rheumatology, Peking Union Medical College Hospital
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 IgG4-related Disease, run by Peking Union Medical College Hospital at 1 site in China.
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 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: looking for participants now, as of the sponsor's last update on 11 Apr 2017. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hua Chen, MD (86-10-69158797, chen77hua@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response (time frame: 6 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 NCT01670695, 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 11 Apr 2017.