Efficacy and Safety of Mycophenolate Mofetil in subjectswithSjogren's Syndrome

NCT02691949 | Unknown Phase 2

• 1 other identifier: S10418-4
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Change of Composite Index of Sjogren's syndrome

  baseline, 28 week

Secondary Outcomes (9)

• ocular dryness

  baseline, 28 week

• physician visual analog scale (VAS)

  baseline, 28 week

• Schirmer's test

  baseline, 28 week

• Saxon's test

  baseline, 28 week

• heart rate

  baseline, 28 week

Study Arms (2)

Mycophenolate mofetil standard

EXPERIMENTAL

mycophenolate mofetil 250mg 2# twice per day (BID)

Drug: Mycophenolate mofetil

Mycophenolate sodium low

EXPERIMENTAL

mycophenolate mofetil 250mg 1# twice per day (BID)

Drug: Mycophenolate mofetil

Interventions

Mycophenolate mofetil DRUG

mycophenolate mofetil 1# BID-2# BID

Mycophenolate mofetil standard; Mycophenolate sodium low

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• fatigue: 0mm (very bad) to 100mm (very good)
• xerostomia: 0mm (very bad) to 100mm (very good)
• Adequate contraception for patients of childbearing potential

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kaohsiung Medical University: lead

Related Publications (1)

• 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.

  PMID: 17986340 RESULT

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Jeng-Hsien Yen

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 25, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: September 23, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share