A Prospective Cohort Study of IgG4RD in China

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital

About this trial

This is an cohort study to investigate the disease course and treatment response of patients with IgG4-related disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females

Age 18-75 years old with informed consent

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)

Disqualifiers

Females planning to bear a child recently or with childbearing potential

Concurrent severe and/or uncontrolled and/or unstable diseases

Patient with malignancy

Trial population

Adult patients with newly diagnosed IgG4-related disease.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: IgG4-RD

Trial outcomes

Primary outcomes

1

Clinical Response

Clinical Response is measured by IgG4-RD Responder Index, including organ/site score and serum IgG4 level.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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