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Trial record 47 of 1164 for:    MYCOPHENOLIC ACID

Efficacy and Safety of Mycophenolate Mofetil in subjectswithSjogren's Syndrome

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ClinicalTrials.gov Identifier: NCT02691949
Recruitment Status : Unknown
Verified September 2016 by Jeng-Hsien Yen, Kaohsiung Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : February 25, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Jeng-Hsien Yen, Kaohsiung Medical University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Sjogren's Syndrome Drug: Mycophenolate mofetil Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Mycophenolate Mofetil in subjectswithSjogren's Syndrome
Study Start Date : February 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018


Arm Intervention/treatment
Experimental: Mycophenolate mofetil standard
mycophenolate mofetil 250mg 2# twice per day (BID)
Drug: Mycophenolate mofetil
mycophenolate mofetil 1# BID-2# BID

Experimental: Mycophenolate sodium low
mycophenolate mofetil 250mg 1# twice per day (BID)
Drug: Mycophenolate mofetil
mycophenolate mofetil 1# BID-2# BID




Primary Outcome Measures :
  1. Change of Composite Index of Sjogren's syndrome [ Time Frame: baseline, 28 week ]

Secondary Outcome Measures :
  1. ocular dryness [ Time Frame: baseline, 28 week ]
    We will calculate the change of ocular dryness from baseline to week 28 (0mm [very bad] to 100mm [very good])

  2. physician visual analog scale (VAS) [ Time Frame: baseline, 28 week ]
    We will calculate the change of physician VAS from baseline to week 28 (0mm [very bad] to 100mm [very good])

  3. Schirmer's test [ Time Frame: baseline, 28 week ]
    We will calculate the change of Schirmer's test results from baseline to week 28

  4. Saxon's test [ Time Frame: baseline, 28 week ]
    We will calculate the change of Saxon's test results from baseline to week 28

  5. heart rate [ Time Frame: baseline, 28 week ]
    resting heart rate

  6. blood pressure [ Time Frame: baseline, 28 week ]
    resting blood pressure

  7. leukocyte count [ Time Frame: baseline, 28 week ]
    WBC count

  8. Hb level [ Time Frame: baseline, 28 week ]
    Hb level

  9. platelet count [ Time Frame: baseline, 28 week ]
    platelet count



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691949


Sponsors and Collaborators
Kaohsiung Medical University
Investigators
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Principal Investigator: Jeng-Hsien Yen Kaohsiung Medical University
Study Director: Wen-Chan Tsai Kaohsiung Medical University
Study Director: Tsan-Teng Ou, MD Kaohsiung Medical University
Study Director: Cheng-Chin Wu, MD Kaohsiung Medical University
Study Director: Wan-Yu Sung, MD Kaohsiung Medical University
Study Director: Chia-Chun Tseng, MD Kaohsiung Medical University

Publications of Results:
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Responsible Party: Jeng-Hsien Yen, Professor, Kaohsiung Medical University
ClinicalTrials.gov Identifier: NCT02691949     History of Changes
Other Study ID Numbers: S10418-4
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We won't share our data

Additional relevant MeSH terms:
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Mycophenolic Acid
Syndrome
Sjogren's Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action