Autoimmune DiseaseNCT03715699
Leflunomide Treatment for IgG4-RD
A study testing Prednisone and Prednisone and Leflunomide in people with Autoimmune Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of Leflunpomide plus glucocorticoid. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autoimmune Disease
- What is being tested?
- Prednisone and Prednisone and Leflunomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Dec 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females
- Aged 18 to 70 years old with informed consent
- All patients must meet the following diagnostic criteria of IgG4RD (2011):
- swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, 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). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD;
- exclusion of other diseases.
Who cannot join
- Patients will not be included if meets any of the following criteria:
- Patients who were diagnosed as other autoimmune diseases;
- Patients who were diagnosed as malignant diseases;
- Pregnant and lactating women；
- Active infection: HIV, HCV, HBV, TB；
- Serious organ function failure, expected life time less than 6 months.
- Presenting with Mikulicz disease without other manifestations.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yunyun Fei
Beijing, Beijing Municipality, 100032
Yunyun Fei, +8613681125226, feiyunyun2013@hotmail.com
About this study
This study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of Leflunpomide plus glucocorticoid.
- Conditions
- Autoimmune Disease
- Being tested
- Prednisone, Prednisone and Leflunomide
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 7.5mg to 10mg/d to 12 months.
Prednisone and LeflunomideDrug
Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months.
Leflunomide: 20mg qd for 6 months and 10mg qd for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients treated with single glucocorticoid Receives: Drug: Prednisone; Drug: Prednisone and Leflunomide |
| Group 2 | Experimental | Patients treated with Leflunomide and glucocorticoid Receives: Drug: Prednisone; Drug: Prednisone and Leflunomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of Leflunomide treatment for IgG4-RD
Complete response rate; Partial response rate; No response
Measured: 1 year
Secondary outcomes (1)
Relapse of Leflunomide treatment for IgG4-RD
Clinical relapse; Serological relapse
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Jul 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715699
- Sponsor's protocol ID
- Treatment for IgG4-RD
- Status last verified
- Oct 2018
- First submitted
- 25 Sep 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leflunomide Treatment for IgG4-RD
- ClinicalTrials.gov ID
- NCT03715699
- Acronym / sponsor ID
- Treatment for IgG4-RD
- Conditions
- Autoimmune Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 Oct 2018 (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.
This study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of Leflunpomide plus glucocorticoid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Prednisone, Drug: Prednisone and LeflunomidePatients treated with single glucocorticoid |
| Group 2 | Experimental | Drug: Prednisone, Drug: Prednisone and LeflunomidePatients treated with Leflunomide and glucocorticoid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females
- Aged 18 to 70 years old with informed consent
- All patients must meet the following diagnostic criteria of IgG4RD (2011):
Key exclusion criteria (7 listed)
- Patients will not be included if meets any of the following criteria:
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 |
|---|---|---|
| PrednisonePrednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 7.5mg to 10mg/d to 12 months. | Drug | Group 1, Group 2 |
| Prednisone and LeflunomidePrednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months. Leflunomide: 20mg qd for 6 months and 10mg qd for 6 months. | Drug | Group 1, Group 2 |
Primary outcome
Response of Leflunomide treatment for IgG4-RD
Time frame: 1 year
Complete response rate; Partial response rate; No response
1 secondary outcome
Relapse of Leflunomide treatment for IgG4-RD
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prednisone and Prednisone and Leflunomide in people with Autoimmune 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 7 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 23 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunyun FEI (+8613681125226, feiyunyun2013@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of Leflunomide treatment for IgG4-RD (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2018.