UveitisNCT01261169
Mycophenolate Sodium (Myfortic®) in the Treatment of Corticosteroid-refractory Autoimmune Uveitis:Pilot Study
An observational study of Uveitis, run by Genovate Biotechnology Co., Ltd., at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- What is being tested?
- Myfortic
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Dec 2011
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: About 40 patients with uveitis
Who may be able to join
- Men or women ≥ 18 years of age with corticosteroid-refractory uveitis due to one of the inflammatory conditions listed below:
- 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.
- 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.
- Behçet's syndrome: the international classification criteria of the International Society for Behçet's Disease (ISBD) will be used to define these patients.
- 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.
- Vogt-Koyanagi-Harada disease (VKH) as defined according to the international Workgroup definition of VKH.
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- 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.
- Idiopathic panuveitis: all non-infectious panuveititides that can not be related to the diseases mentioned above.
- 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.
- 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.
- Visual acuity of 0.1 or better in at least one eye.
- 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.
- The screening laboratory test results must meet the following criteria:
- Hemoglobin ≥ 10.5 g/dL
- WBC ≥ 3.0 x 103/μL
- Neutrophils ≥ 1.5 x 103/μL
- Platelets ≥ 1 x 103/μL
- SGOT (AST) and alkaline phosphatase levels must be within 3 times the upper limit of normal range for the laboratory conducting the test (3xULN).
- Creatinine clearance > 25 ml/min
- Must have a normal chest radiograph within 3 months prior to first therapy with no evidence of malignancy, infection or TB.
- Patient must be able to adhere to the study visit schedule and other protocol requirements.
- The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures.
Who cannot join
- Inability to visualize the fundus due to corneal or lenticular opacities.
- Patients requiring ocular surgery within the initial 3 months of treatment, or who have had surgery in the prior 3 months.
- Women who are pregnant, nursing, or planning pregnancy within 6 months after screening (i.e., approximately 6 weeks following last treatment).
- Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
- Recent history of systemic immunosuppressive therapy, other than steroids for ocular disease within 2 months.
- Creatinine clearance of < 25ml/min or serum creatinine level higher than 1.5 mg/dl
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- Patients with known hypersensitivity to prednisone, Myfortic® or drugs with similar chemical structures.
- Patients with any clinically significant infection.
- Documented HIV infection.
- Patients with active TB or evidence of latent TB.
- Patients with positive Lues serology and or significant Lues infection.
- 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.
- Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic,hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
- Presence of a transplanted organ (with the exception of a corneal transplant 3 months prior to screening).
- Malignancy within the past 5 years (except for treated squamous or basal cell carcinoma of the skin without evidence of recurrence).
- 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.
- Known recent substance abuse (drugs or alcohol).
- Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.
- Recent live vaccinations
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
CGMH
Taoyuan County, Taiwan, 333
Hwang Yih Shiou, MD, 886-3-3281200 ext. 8666, yihshiou.hwang@gmail.com
About this study
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.
Read the 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.
- Conditions
- Uveitis
- Being tested
- Myfortic
- Keywords
- Mycophenolate sodium (Myfortic®), Corticosteroid-refractory autoimmune Uveitis
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyforticDrug
Myfortic in uveitis
| Study group | Role | What they receive |
|---|---|---|
| Myfortic | Not described Receives: Drug: Myfortic |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startJan 2009
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Investigators
- Hwang Yih Shiou, MD, Principal investigator, CGMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261169
- Sponsor's protocol ID
- CERL080ATW06T
- Status last verified
- Dec 2010
- First submitted
- 14 Dec 2010
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycophenolate Sodium (Myfortic®) in the Treatment of Corticosteroid-refractory Autoimmune Uveitis:Pilot Study
- ClinicalTrials.gov ID
- NCT01261169
- Acronym / sponsor ID
- CERL080ATW06T
- Conditions
- Uveitis
- Keywords
- Mycophenolate sodium (Myfortic®), Corticosteroid-refractory autoimmune Uveitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- Jan 2009
- Study completion
- Dec 2011 (estimated)
- First posted
- 16 Dec 2010 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myfortic | – | Drug: Myfortic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- About 40 patients with uveitis
Key inclusion criteria (22 listed)
- Men or women ≥ 18 years of age with corticosteroid-refractory uveitis due to one of the inflammatory conditions listed below:
- 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.
- Visual acuity of 0.1 or better in at least one eye.
- 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.
- The screening laboratory test results must meet the following criteria:
Key exclusion criteria (19 listed)
- Inability to visualize the fundus due to corneal or lenticular opacities.
- Patients requiring ocular surgery within the initial 3 months of treatment, or who have had surgery in the prior 3 months.
- Women who are pregnant, nursing, or planning pregnancy within 6 months after screening (i.e., approximately 6 weeks following last treatment).
- Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
- Recent history of systemic immunosuppressive therapy, other than steroids for ocular disease within 2 months.
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 |
|---|---|---|
| MyforticMyfortic in uveitis | Drug | Myfortic |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2010.
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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.
Hwang Yih Shiou, MD principal investigator
CGMH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, run by Genovate Biotechnology Co., Ltd., at 1 site in Taiwan.
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 22 inclusion and 19 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 16 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Contact Hwang Yih Shiou, MD (886-3-3281200 ext. 8666, yihshiou.hwang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 16 Dec 2010.