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IgG4-related DiseasePhase 2/3NCT01758393

Glucocorticoids in Patients With IgG4-RD

A Phase 2/3 study testing Prednisone in people with IgG4-related Disease, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized, open-label, single-center clinical trial to compare the efficacy and safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related Disease. Patients will be followed for three months to measure the primary outcome and secondary outcomes. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
IgG4-related Disease
What is being tested?
Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
Dec 2012to Apr 2014
Phase
Phase 2/3
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females
  • Age 18-70 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

  • Previously or currently received glucocorticoid and(or) immunomodulator
  • Pregnancy or lactating
  • Concurrent severe and/or uncontrolled and/or unstable diseases
  • Patient with malignancy

Trial locations and contacts

1 site in 1 country.

Hua Chen, MD contact

+86-10-69158797

chenhua@pumch.cn

China1 site, 1 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, chenhua@pumch.cn

    Recruiting

Other trials in China

About this study

Official title: A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease

This is a randomized, open-label, single-center clinical trial to compare the efficacy and safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related Disease. Patients will be followed for three months to measure the primary outcome and secondary outcomes.

Being tested
Prednisone
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 groups in NCT01758393
Study groupRoleWhat they receive
Medium DoseExperimentalPatients are treated with prednisone or equivlent at doseage of 0.5-0.6 mg/kg/d (max 40mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.
Receives: Drug: Prednisone
High DoseExperimentalPatients are treated with prednisone or equivlent at doseage of 0.8-1.0 mg/kg/d (max 60mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.
Receives: Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response

    Complete Response(CR) is defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies.

    Measured: 3 months

Secondary outcomes (2)

  1. Disease Response

    Disease Response is measured by IgG4-RD Responder Index(IgG4-RD RI) and defined as:

    • Improvement of > 2 points in the IgG4-RD RI over baseline
    • No disease flares, as assessed by the IgG4-RD RI.

    Measured: 3 months

  2. Adverse Effect

    Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionJan 2014 (estimated)
  4. Study completionApr 2014 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01758393
Sponsor's protocol ID
PUMCH-GC-IgG4RD
Status last verified
Dec 2012
First submitted
24 Dec 2012
Last updated
1 Jan 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Prednisone in people with 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 4 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 1 Jan 2013. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Hua Chen, MD (+86-10-69158797, chenhua@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response (time frame: 3 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 NCT01758393.

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 1 Jan 2013.

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