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Register:	ClinicalTrials.gov
Last refreshed on:	3 October 2016
Main ID:	NCT02691949
Date of registration:	16/02/2016
Prospective Registration:	No
Primary sponsor:	Kaohsiung Medical University
Public title:	Efficacy and Safety of Mycophenolate Mofetil in subjectswithSjogren's Syndrome
Scientific title:	Efficacy and Safety of Mycophenolate Mofetil in subjectswithSjogren's Syndrome
Date of first enrolment:	February 2016
Target sample size:	54
Recruitment status:	Enrolling by invitation
URL:	https://clinicaltrials.gov/show/NCT02691949
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase:	Phase 2

Countries of recruitment

Contacts

Name:	Wan-Yu Sung, MD
Address:
Telephone:
Email:
Affiliation:	Kaohsiung Medical University

Name:	Cheng-Chin Wu, MD
Address:
Telephone:
Email:
Affiliation:	Kaohsiung Medical University

Name:	Jeng-Hsien Yen
Address:
Telephone:
Email:
Affiliation:	Kaohsiung Medical University

Name:	Tsan-Teng Ou, MD
Address:
Telephone:
Email:
Affiliation:	Kaohsiung Medical University

Name:	Chia-Chun Tseng, MD
Address:
Telephone:
Email:
Affiliation:	Kaohsiung Medical University

Name:	Wen-Chan Tsai
Address:
Telephone:
Email:
Affiliation:	Kaohsiung Medical University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of primary Sjogren's syndrome based on the 2002 American-European Consensus
criteria

2. Aged 20 to 75 years

3. Stable doses of oral corticosteroids(?5mg/d) for at least 4 weeks before enrollment

4. Intolerance or inadequate response to hydroxychloroquine and (pilocarpine or
cevimeline), defined as less than 50mm on at least 2 of VAS including:

1. global assessment : 0mm (very bad) to 100mm (very good)

2. pain: 0mm (very bad) to 100mm (very good)

3. fatigue: 0mm (very bad) to 100mm (very good)

4. xerostomia: 0mm (very bad) to 100mm (very good)

5. Adequate contraception for patients of childbearing potential

Exclusion Criteria:

1. 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

2. Any one of laboratory abnormalities:

1. Serum creatinine =2 mg/dl

2. aspartate aminotransferase (AST) or alanine transaminase (ALT) more than 1.5 x
upper normal range of the laboratory

3. Leukopenia (WBC<4000/µl)

4. Hb = 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females

5. Neutrophil less than 1.5 x 109/l

6. Platelet count less than 150 x 109/l

3. History of other autoimmune diseases

4. Use topical cyclosporine eyedrops, antihistamine, anticholinergic, antidepressant, or
antipsychotic drug with possible effects on ocular dryness or oral dryness within 1
month

5. Pregnant or lactating women

6. Previous or current malignancies adequately controlled less than 5 years, hepatitis
B, hepatitis C, HIV infection, tuberculosis, or diabetes

7. Subjects with serious infections requiring hospitalization within the last 12 months

8. Subjects with herpes zoster or cytomegalovirus that resolved less than 2 months
before enrollment

9. Subjects who have received any live vaccines within 3 months

10. 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

11. History of recurring or chronic infections or underlying conditions which may further
predispose patients to serious infection

12. Subjects who are impaired, incapacitated, or incapable of completing study-related
assessments

13. History of allergy to mycophenolate sodium

14. Nausea, vomiting, diarrhea within 1 week before enrollment

15. History of psychosis, seizure, retinopathy

16. Infection 2 weeks before enrollment

17. Heart rate < 60/min at rest

Age minimum: 20 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Sjogren's Syndrome

Intervention(s)

Drug: Mycophenolate mofetil

Primary Outcome(s)

Change of Composite Index of Sjogren's syndrome [Time Frame: baseline, 28 week]

Secondary Outcome(s)

physician visual analog scale (VAS) [Time Frame: baseline, 28 week]

Saxon's test [Time Frame: baseline, 28 week]

leukocyte count [Time Frame: baseline, 28 week]

Schirmer's test [Time Frame: baseline, 28 week]

heart rate [Time Frame: baseline, 28 week]

ocular dryness [Time Frame: baseline, 28 week]

platelet count [Time Frame: baseline, 28 week]

blood pressure [Time Frame: baseline, 28 week]

Hb level [Time Frame: baseline, 28 week]

Secondary ID(s)

S10418-4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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