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Mycophenolate Sodium (Myfortic®) in the Treatment of Corticosteroid-refractory Autoimmune Uveitis:Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01261169
Recruitment Status : Unknown
Verified December 2010 by Genovate Biotechnology Co., Ltd.,.
Recruitment status was:  Recruiting
First Posted : December 16, 2010
Last Update Posted : December 16, 2010
Information provided by:
Genovate Biotechnology Co., Ltd.,

Brief Summary:
This study is designed to explore the use of Myfortic® in patients with steroid-refractory uveitis. The aim of the study will be to show the therapeutic effect of Myfortic® in managing uveitis patients.

Condition or disease Intervention/treatment
Uveitis Drug: Myfortic

Detailed Description:

This study is a single arm prospective evaluation in which patients with uveitis are treated with Myfortic® in a dose of 360 mg bid for six months. From day 0, Myfortic will be combined with 1 mg/kg prednisone. Prednisone will be tapered from week 1 based on the clinical findings of the ophthalmologist.

There will be no other stratification of patients. After the screening, patients will be treated with Myfortic® for 6 months. Patients will be seen at month 1, 3, and 6. Thereafter patients will be followed up at month 12. Efficacy and safety assessments will be performed at each visit.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mycophenolate Sodium (Myfortic®) in the Treatment of Corticosteroid-refractory Autoimmune Uveitis:Pilot Study
Study Start Date : January 2009
Estimated Study Completion Date : December 2011

Group/Cohort Intervention/treatment
Myfortic Drug: Myfortic
Myfortic in uveitis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
About 40 patients with uveitis

Inclusion Criteria:

  1. Men or women ≥ 18 years of age with corticosteroid-refractory uveitis due to one of the inflammatory conditions listed below:

    1. Ocular sarcoidosis: a granulomatous uveitis with posterior inflammation in a patient in which sarcoidosis has been established by means of a biopsy, cytology, or a positive scan.
    2. Intermediate uveitis: patients with clinical features as defined by the IUSG23. However, it is important that the patient has no evidence of a systemic infection such as Lyme Borreliosis and that there is no history of neurological symptoms likely to be associated with multiple sclerosis. All patients with intermediate uveitis should have a negative MRI with gadolinium contrast, prior to being enrolled.
    3. Behçet's syndrome: the international classification criteria of the International Society for Behçet's Disease (ISBD) will be used to define these patients.
    4. Idiopathic Retinal Vasculitis where systemic or infectious causes have been eliminated. In particular patients will not have evidence of Wegener's granulomatosis, SLE, PAN, polymyositis, dermatomyositis or other systemic vasculitic disorders. Patients must also lack evidence for a systemic infection, and have been adequately screened. For the purpose of this study, Eale's disease will be excluded from the idiopathic retinal vasculitis group. However, both non-occlusive and occlusive types of retinal vasculitis can be included in the study.
    5. Vogt-Koyanagi-Harada disease (VKH) as defined according to the international Workgroup definition of VKH.
    6. Sympathetic ophthalmia: a granulomatous uveitis involving the choroid and retina, characterized by multiple white-yellow lesions often in the periphery, which can coalesce particularly in the circumpapillary region. It is associated with trauma or multiple prior surgeries.
    7. Idiopathic panuveitis: all non-infectious panuveititides that can not be related to the diseases mentioned above.
    8. Corticosteroid-refractory uveitis patient is defined as the patient who receive steroid treatment and cannot lower the dosage of steroid to less than 10mg per day in 3 months due to the clinical condition.
  2. Disease that is 5 years or less in duration, with a significant flare in the past 24 months requiring intensification of anti-inflammatory therapy (predsinolone). A significant flare is defined as a drop of 2 lines of vision on an ETDRS chart or equivalent, or increase in vitreous flare by 2 grades.
  3. Visual acuity of 0.1 or better in at least one eye.
  4. Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicidal cream, or surgical sterilization) for the duration of the study and should continue such precautions for 6 weeks after receiving the last administration.
  5. The screening laboratory test results must meet the following criteria:

    1. Hemoglobin ≥ 10.5 g/dL
    2. WBC ≥ 3.0 x 103/μL
    3. Neutrophils ≥ 1.5 x 103/μL
    4. Platelets ≥ 1 x 103/μL
    5. SGOT (AST) and alkaline phosphatase levels must be within 3 times the upper limit of normal range for the laboratory conducting the test (3xULN).
    6. Creatinine clearance > 25 ml/min
  6. Must have a normal chest radiograph within 3 months prior to first therapy with no evidence of malignancy, infection or TB.
  7. Patient must be able to adhere to the study visit schedule and other protocol requirements.
  8. The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures.

Exclusion Criteria:

  1. Inability to visualize the fundus due to corneal or lenticular opacities.
  2. Patients requiring ocular surgery within the initial 3 months of treatment, or who have had surgery in the prior 3 months.
  3. Women who are pregnant, nursing, or planning pregnancy within 6 months after screening (i.e., approximately 6 weeks following last treatment).
  4. Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
  5. Recent history of systemic immunosuppressive therapy, other than steroids for ocular disease within 2 months.
  6. Creatinine clearance of < 25ml/min or serum creatinine level higher than 1.5 mg/dl
  7. Patients with known hypersensitivity to prednisone, Myfortic® or drugs with similar chemical structures.
  8. Patients with any clinically significant infection.
  9. Documented HIV infection.
  10. Patients with active TB or evidence of latent TB.
  11. Patients with positive Lues serology and or significant Lues infection.
  12. Patients with opportunistic infections, including but not limited to evidence of active cytomegalovirus, active Pneumocystis carinii, Aspergillosis, Histoplasmosis or atypical mycobacterium infection, etc, within the previous 6 months.
  13. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic,hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
  14. Presence of a transplanted organ (with the exception of a corneal transplant 3 months prior to screening).
  15. Malignancy within the past 5 years (except for treated squamous or basal cell carcinoma of the skin without evidence of recurrence).
  16. History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.
  17. Known recent substance abuse (drugs or alcohol).
  18. Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.
  19. Recent live vaccinations

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 identifier (NCT number): NCT01261169

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Contact: Hwang Yih Shiou, MD 886-3-3281200 ext 8666

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CGMH Recruiting
Taoyuan County, Taiwan, 333
Contact: Hwang Yih Shiou, MD    886-3-3281200 ext 8666   
Sponsors and Collaborators
Genovate Biotechnology Co., Ltd.,
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Principal Investigator: Hwang Yih Shiou, MD CGMH
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Responsible Party: Yih-Shiou Hwang Identifier: NCT01261169    
Other Study ID Numbers: CERL080ATW06T
First Posted: December 16, 2010    Key Record Dates
Last Update Posted: December 16, 2010
Last Verified: December 2010
Keywords provided by Genovate Biotechnology Co., Ltd.,:
Mycophenolate sodium (Myfortic®)
Corticosteroid-refractory autoimmune Uveitis
Additional relevant MeSH terms:
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Uveal Diseases
Eye Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action