Sjogren Syndrome With Other Organ InvolvementPhase 2/3NCT05694130
Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS
A Phase 2/3 study testing Prednisolone and Tacrolimus in people with Sjogren Syndrome With Other Organ Involvement, run by Peking Union Medical College Hospital.
Trial summary
This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for Sjogren's syndrome patients with severe thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sjogren Syndrome With Other Organ Involvement
- What is being tested?
- Prednisolone and Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Dec 2024
- 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
- Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria.
- Baseline platelet counts less than 30×109/L.
Who cannot join
- Concomitant other systemic autoimmune diseases.
- Other severe complications of Sjogren's syndrome.
- Abnormal laboratory tests such as: white blood cell count <2.5x10^9/L, hemoglobin <80 g/L, AST/ALT >1.5 ULN, serum creatine > 1.5 mg/dL.
- Received glucocorticoids, immunosuppressants, or biological agents within 3 months.
- Active acute or chronic infections.
- History of malignancy.
- Pregnancy or breastfeeding.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in Sjogren's Syndrome
This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for Sjogren's syndrome patients with severe thrombocytopenia.
Read the detailed description
This study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for the treatment of severe thrombocytopenia in Sjogren's syndrome patients.
- Being tested
- Prednisolone, Tacrolimus
- Keywords
- Sjogren's syndrome, Thrombocytopenia, Tacrolimus
- Medical subject headings
- Sjogren's Syndrome, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.
TacrolimusDrug
Oral Tacrolimus 1-2mg twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone monotherapy | Placebo comparator | Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks. Receives: Drug: Prednisolone |
| Prednisolone plus Tacrolimus | Experimental | Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks. Oral tacrolimus 1-2mg twice daily for 12 weeks. Receives: Drug: Prednisolone; Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Complete response (platelet counts > 100×10^9/L) rates at week 12.
Measured: week 12
Secondary outcomes (4)
Complete response rate
Complete response (platelet counts > 100×10^9/L) rates at week 4 and week 8.
Measured: week 4 and week 8
Partial response rate
Partial response (platelet counts 50-100×10^9/L) rates at week 4, week 8 and week 12
Measured: week 4, week 8 and week 12
ESSDAI improvement
Change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score (0-123, higher is worse) at week 12.
Measured: week 12
ESSPRI improvement
Change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score (0-10, higher is worse) at week 12.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren Syndrome With Other Organ InvolvementStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 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
- NCT05694130
- Sponsor's protocol ID
- I-22PJ1065b
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT05694130
- Acronym / sponsor ID
- I-22PJ1065b
- Keywords
- Sjogren's syndrome, Thrombocytopenia, Tacrolimus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Jan 2023 (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 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for Sjogren's syndrome patients with severe thrombocytopenia.
Detailed description
This study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for the treatment of severe thrombocytopenia in Sjogren's syndrome patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone monotherapy | Placebo comparator | Drug: PrednisoloneOral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks. |
| Prednisolone plus Tacrolimus | Experimental | Drug: Prednisolone, Drug: TacrolimusOral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks. Oral tacrolimus 1-2mg twice daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria.
- Baseline platelet counts less than 30×109/L.
Key exclusion criteria (7 listed)
- Concomitant other systemic autoimmune diseases.
- Other severe complications of Sjogren's syndrome.
- Abnormal laboratory tests such as: white blood cell count <2.5x10^9/L, hemoglobin <80 g/L, AST/ALT >1.5 ULN, serum creatine > 1.5 mg/dL.
- Received glucocorticoids, immunosuppressants, or biological agents within 3 months.
- Active acute or chronic infections.
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 |
|---|---|---|
| PrednisoloneOral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks. | Drug | Prednisolone monotherapy, Prednisolone plus Tacrolimus |
| TacrolimusOral Tacrolimus 1-2mg twice daily for 12 weeks. | Drug | Prednisolone plus Tacrolimus |
Primary outcome
Complete response rate
Time frame: week 12
Complete response (platelet counts > 100×10^9/L) rates at week 12.
4 secondary outcomes
Complete response rate
Time frame: week 4 and week 8
Partial response rate
Time frame: week 4, week 8 and week 12
ESSDAI improvement
Time frame: week 12
ESSPRI improvement
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Prednisolone and Tacrolimus in people with Sjogren Syndrome With Other Organ Involvement, run by Peking Union Medical College Hospital.
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 2 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 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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, Dr. (861069159962, 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 rate (time frame: week 12). 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 Jan 2023.