Sjogren's SyndromePhase 1/2NCT03023592
Study of Iguratimod in Sjögren's Syndrome
A Phase 1/2 study testing Iguratimod in people with Sjogren's Syndrome, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
A single-center, self-control, open-label study of efficacy and safety of Iguratimod in patients with Sjögren's Syndrome Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Iguratimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Feb 2017to Apr 2018
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
- Positive dry eyes and (or) dry mouth symptoms
- Hyperglobulinemia
Who cannot join
- Complicated with other systemic autoimmune diseases
- Severe complications of Sjogren's syndrome
- Glucocorticosteroid therapy, systemic immunosuppressant therapy, or biological agents therapy within 3 months prior to the screening visit
- Active infections or chronic infectious diseases
- A history of malignancies
- Pregnancy or breathfeeding
- Inability to comply with the study protocol for any other reason
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Hua Chen, Dr., 86-10-69158797, chenhua@pumch.cn
Yan Zhao, Dr.
About this study
Official title: A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome
A single-center, self-control, open-label study of efficacy and safety of Iguratimod in patients with Sjögren's Syndrome
Read the detailed description
In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score, unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's Syndrome.
- Conditions
- Sjogren's Syndrome
- Being tested
- Iguratimod
- Keywords
- Sjogren's Syndrome, Iguratimod
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IguratimodDrug
Also called T-614
Iguratimod 25 mg orally twice a day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Iguratimod | Experimental | Patients are treated with Iguratimod 25 mg Twice a day for 24 weeks. Receives: Drug: Iguratimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
ESSDAI improvement
The change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 24 weeks.
Measured: week 24
ESSPRI improvement
The change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at 24 weeks.
Measured: week 24
Secondary outcomes (6)
Unstimulated salivary flow rate
The change from baseline in unstimulated salivary flow rate at 24 weeks.
Measured: week 24
Schimer's test
The change from baseline in Schimer's test at 24 weeks.
Measured: week 24
SF-36
The change from baseline in SF-36 score at 24 weeks.
Measured: week 24
HAQ
The change from baseline in HAQ score at 24 weeks.
Measured: week 24
Immunoglobulins
The change from baseline in IgG, IgM and IgA levels at 24 weeks.
Measured: week 24
Rheumatoid Factors
The change from baseline in titer of rheumatoid factors at 24 weeks.
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startFeb 2017
- Primary completionFeb 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Zhao, Dr., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023592
- Sponsor's protocol ID
- PUMCH170115
- Status last verified
- Jan 2017
- First submitted
- 15 Jan 2017
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT03023592
- Acronym / sponsor ID
- PUMCH170115
- Conditions
- Sjogren's Syndrome
- Keywords
- Sjogren's Syndrome, Iguratimod
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 18 Jan 2017 (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.
A single-center, self-control, open-label study of efficacy and safety of Iguratimod in patients with Sjögren's Syndrome
Detailed description
In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score, unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iguratimod | Experimental | Drug: IguratimodPatients are treated with Iguratimod 25 mg Twice a day for 24 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
- Positive dry eyes and (or) dry mouth symptoms
- Hyperglobulinemia
Key exclusion criteria (7 listed)
- Complicated with other systemic autoimmune diseases
- Severe complications of Sjogren's syndrome
- Glucocorticosteroid therapy, systemic immunosuppressant therapy, or biological agents therapy within 3 months prior to the screening visit
- Active infections or chronic infectious diseases
- A history of malignancies
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 |
|---|---|---|
| IguratimodAlso: T-614Iguratimod 25 mg orally twice a day for 24 weeks | Drug | Iguratimod |
Primary outcome
ESSDAI improvement
Time frame: week 24
The change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 24 weeks.
ESSPRI improvement
Time frame: week 24
The change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at 24 weeks.
6 secondary outcomes
Unstimulated salivary flow rate
Time frame: week 24
Schimer's test
Time frame: week 24
SF-36
Time frame: week 24
HAQ
Time frame: week 24
Immunoglobulins
Time frame: week 24
Rheumatoid Factors
Time frame: week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Yan Zhao, Dr. principal investigator
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?
A Phase 1/2 study testing Iguratimod in people with Sjogren's Syndrome, 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 3 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 18 Jan 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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, Dr. (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?
ESSDAI improvement (time frame: week 24). The study lists 2 primary outcomes in all. 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 18 Jan 2017.