Sjogren's SyndromePhase 2NCT02691949
Efficacy and Safety of Mycophenolate Mofetil in subjectswithSjogren's Syndrome
A Phase 2 study testing Mycophenolate mofetil in people with Sjogren's Syndrome, run by Kaohsiung Medical University.
Trial summary
Past literature showed encouraging effects of mycophenolate on dryness symptoms and quality of life in patients with Sjogren's syndrome. Mycophenolate also has excellent immunomodulation effects in lupus nephritis. Currently Mycophenolate is only used in lupus nephritis and organ transplant. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Mycophenolate mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Apr 2018
- Phase
- Phase 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary Sjogren's syndrome based on the 2002 American-European Consensus criteria
- Aged 20 to 75 years
- Stable doses of oral corticosteroids(≦5mg/d) for at least 4 weeks before enrollment
- Intolerance or inadequate response to hydroxychloroquine and (pilocarpine or cevimeline), defined as less than 50mm on at least 2 of VAS including:
- global assessment : 0mm (very bad) to 100mm (very good)
- pain: 0mm (very bad) to 100mm (very good)
Show all 9Show fewer
- fatigue: 0mm (very bad) to 100mm (very good)
- xerostomia: 0mm (very bad) to 100mm (very good)
- Adequate contraception for patients of childbearing potential
Who cannot join
- Receiving biologics during the 6 previous months or any other immunosuppressant (methotrexate, cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil (MMF), mycophenolate sodium, leflunomide, penicillamine) during the previous month
- Any one of laboratory abnormalities:
- Serum creatinine ≥2 mg/dl
- aspartate aminotransferase (AST) or alanine transaminase (ALT) more than 1.5 x upper normal range of the laboratory
- Leukopenia (WBC<4000/μl)
- Hb ≤ 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females
Show all 23Show fewer
- Neutrophil less than 1.5 x 109/l
- Platelet count less than 150 x 109/l
- History of other autoimmune diseases
- Use topical cyclosporine eyedrops, antihistamine, anticholinergic, antidepressant, or antipsychotic drug with possible effects on ocular dryness or oral dryness within 1 month
- Pregnant or lactating women
- Previous or current malignancies adequately controlled less than 5 years, hepatitis B, hepatitis C, HIV infection, tuberculosis, or diabetes
- Subjects with serious infections requiring hospitalization within the last 12 months
- Subjects with herpes zoster or cytomegalovirus that resolved less than 2 months before enrollment
- Subjects who have received any live vaccines within 3 months
- Underlying cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal, haematological or neurological conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in the study
- History of recurring or chronic infections or underlying conditions which may further predispose patients to serious infection
- Subjects who are impaired, incapacitated, or incapable of completing study-related assessments
- History of allergy to mycophenolate sodium
- Nausea, vomiting, diarrhea within 1 week before enrollment
- History of psychosis, seizure, retinopathy
- Infection 2 weeks before enrollment
- Heart rate < 60/min at rest
About this study
Past literature showed encouraging effects of mycophenolate on dryness symptoms and quality of life in patients with Sjogren's syndrome. Mycophenolate also has excellent immunomodulation effects in lupus nephritis. Currently Mycophenolate is only used in lupus nephritis and organ transplant. It is unknown whether low dosage of mycophenolate mofetil could be used to improve ocular dryness and oral dryness in patients with Sjogren's syndrome.
Read the detailed description
Sjogren's syndrome is one of the most common autoimmune diseases in Taiwan. It is characterized by keratoconjunctivitis sicca and xerostomia. Although it is well established that Sjogren's syndrome is caused by infiltration and destruction of lacrimal gland and salivary gland by lymphocytic cells, effective treatment of patients' symptoms is lacking. Hydroxychloroquine is the most well-studied medication in Sjogren's syndrome. However, recent clinical trials showed disappointing effects of hydroxychloroquine in Sjogren's syndrome. Thus there is an unmet need to find effective treatment for patient's bothering symptoms.
Mycophenolate is a selective inhibitor of inosinemonophosphate dehydrogenase which leads to inhibition of the de novo pathway of nucleotide synthesis. The antiproliferative effect of mycophenolate mainly affects activated T and B lymphocytes because the proliferation of these cells is critically dependent on the de novo purine synthesis compared with other eukaryotic cells. Since these lymphocytes have been suggested to play a pivotal role in the inflammation and immunopathogenesis of Sjogren's syndrome, mycophenolate might be a promising agent in the treatment of Sjogren's syndrome.
Past literature showed encouraging effects of mycophenolate on dryness symptoms and quality of life in patients with Sjogren's syndrome. Mycophenolate also has excellent immunomodulation effects in lupus nephritis. Currently mycophenolate is only used in lupus nephritis and organ transplant. It is unknown whether low dosage of mycophenolate could be used to improve ocular dryness and oral dryness in patients with Sjogren's syndrome.
- Conditions
- Sjogren's Syndrome
- Being tested
- Mycophenolate mofetil
- 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.
mycophenolate mofetil 1# BID-2# BID
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate mofetil standard | Experimental | mycophenolate mofetil 250mg 2# twice per day (BID) Receives: Drug: Mycophenolate mofetil |
| Mycophenolate sodium low | Experimental | mycophenolate mofetil 250mg 1# twice per day (BID) Receives: Drug: Mycophenolate mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Composite Index of Sjogren's syndrome
Measured: baseline, 28 week
Secondary outcomes (9)
ocular dryness
We will calculate the change of ocular dryness from baseline to week 28 (0mm [very bad] to 100mm [very good])
Measured: baseline, 28 week
physician visual analog scale (VAS)
We will calculate the change of physician VAS from baseline to week 28 (0mm [very bad] to 100mm [very good])
Measured: baseline, 28 week
Schirmer's test
We will calculate the change of Schirmer's test results from baseline to week 28
Measured: baseline, 28 week
Saxon's test
We will calculate the change of Saxon's test results from baseline to week 28
Measured: baseline, 28 week
heart rate
resting heart rate
Measured: baseline, 28 week
blood pressure
resting blood pressure
Measured: baseline, 28 week
leukocyte count
WBC count
Measured: baseline, 28 week
Hb level
Hb level
Measured: baseline, 28 week
platelet count
platelet count
Measured: baseline, 28 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeng-Hsien Yen, Kaohsiung Medical University
- Investigators
- Jeng-Hsien Yen, Principal investigator, Kaohsiung Medical UniversityWen-Chan Tsai, Study director, Kaohsiung Medical UniversityTsan-Teng Ou, MD, Study director, Kaohsiung Medical UniversityCheng-Chin Wu, MD, Study director, Kaohsiung Medical UniversityWan-Yu Sung, MD, Study director, Kaohsiung Medical UniversityChia-Chun Tseng, MD, Study director, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691949
- Sponsor's protocol ID
- S10418-4
- Status last verified
- Sep 2016
- First submitted
- 16 Feb 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We won't share our data
Publications
Willeke P, Schluter B, Becker H, Schotte H, Domschke W, Gaubitz M. Mycophenolate sodium treatment in patients with primary Sjogren syndrome: a pilot trial. Arthritis Res Ther. 2007;9(6):R115. doi: 10.1186/ar2322.
PubMed 17986340
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Mycophenolate Mofetil in subjectswithSjogren's Syndrome
- ClinicalTrials.gov ID
- NCT02691949
- Acronym / sponsor ID
- S10418-4
- Conditions
- Sjogren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 25 Feb 2016 (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.
Past literature showed encouraging effects of mycophenolate on dryness symptoms and quality of life in patients with Sjogren's syndrome. Mycophenolate also has excellent immunomodulation effects in lupus nephritis. Currently Mycophenolate is only used in lupus nephritis and organ transplant. It is unknown whether low dosage of mycophenolate mofetil could be used to improve ocular dryness and oral dryness in patients with Sjogren's syndrome.
Detailed description
Sjogren's syndrome is one of the most common autoimmune diseases in Taiwan. It is characterized by keratoconjunctivitis sicca and xerostomia. Although it is well established that Sjogren's syndrome is caused by infiltration and destruction of lacrimal gland and salivary gland by lymphocytic cells, effective treatment of patients' symptoms is lacking. Hydroxychloroquine is the most well-studied medication in Sjogren's syndrome. However, recent clinical trials showed disappointing effects of hydroxychloroquine in Sjogren's syndrome. Thus there is an unmet need to find effective treatment for patient's bothering symptoms.
Mycophenolate is a selective inhibitor of inosinemonophosphate dehydrogenase which leads to inhibition of the de novo pathway of nucleotide synthesis. The antiproliferative effect of mycophenolate mainly affects activated T and B lymphocytes because the proliferation of these cells is critically dependent on the de novo purine synthesis compared with other eukaryotic cells. Since these lymphocytes have been suggested to play a pivotal role in the inflammation and immunopathogenesis of Sjogren's syndrome, mycophenolate might be a promising agent in the treatment of Sjogren's syndrome.
Past literature showed encouraging effects of mycophenolate on dryness symptoms and quality of life in patients with Sjogren's syndrome. Mycophenolate also has excellent immunomodulation effects in lupus nephritis. Currently mycophenolate is only used in lupus nephritis and organ transplant. It is unknown whether low dosage of mycophenolate could be used to improve ocular dryness and oral dryness in patients with Sjogren's syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate mofetil standard | Experimental | Drug: Mycophenolate mofetilmycophenolate mofetil 250mg 2# twice per day (BID) |
| Mycophenolate sodium low | Experimental | Drug: Mycophenolate mofetilmycophenolate mofetil 250mg 1# twice per day (BID) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of primary Sjogren's syndrome based on the 2002 American-European Consensus criteria
- Aged 20 to 75 years
- Stable doses of oral corticosteroids(≦5mg/d) for at least 4 weeks before enrollment
- Intolerance or inadequate response to hydroxychloroquine and (pilocarpine or cevimeline), defined as less than 50mm on at least 2 of VAS including:
- Adequate contraception for patients of childbearing potential
Key exclusion criteria (23 listed)
- Receiving biologics during the 6 previous months or any other immunosuppressant (methotrexate, cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil (MMF), mycophenolate sodium, leflunomide, penicillamine) during the previous month
- Any one of laboratory abnormalities:
- History of other autoimmune diseases
- Use topical cyclosporine eyedrops, antihistamine, anticholinergic, antidepressant, or antipsychotic drug with possible effects on ocular dryness or oral dryness within 1 month
- Pregnant or lactating women
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 |
|---|---|---|
| Mycophenolate mofetilmycophenolate mofetil 1# BID-2# BID | Drug | Mycophenolate mofetil standard, Mycophenolate sodium low |
Primary outcome
Change of Composite Index of Sjogren's syndrome
Time frame: baseline, 28 week
9 secondary outcomes
ocular dryness
Time frame: baseline, 28 week
physician visual analog scale (VAS)
Time frame: baseline, 28 week
Schirmer's test
Time frame: baseline, 28 week
Saxon's test
Time frame: baseline, 28 week
heart rate
Time frame: baseline, 28 week
blood pressure
Time frame: baseline, 28 week
leukocyte count
Time frame: baseline, 28 week
Hb level
Time frame: baseline, 28 week
platelet count
Time frame: baseline, 28 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Results publication: PubMed 17986340Willeke P, Schluter B, Becker H, Schotte H, Domschke W, Gaubitz M. Mycophenolate sodium treatment in patients with primary Sjogren syndrome: a pilot trial. Arthritis Res Ther. 2007;9(6):R115. doi: 10.1186/ar2322.
- Individual participant dataSharing planned: No. We won't share our data
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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.
Jeng-Hsien Yen principal investigator
Kaohsiung Medical University
Wen-Chan Tsai study director
Kaohsiung Medical University
Tsan-Teng Ou, MD study director
Kaohsiung Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mycophenolate mofetil in people with Sjogren's Syndrome, run by Kaohsiung Medical University.
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 9 inclusion and 23 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 Sep 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Composite Index of Sjogren's syndrome (time frame: baseline, 28 week). 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 NCT02691949, which also lists 1 linked publication.
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 Sep 2016.