|- candidate number||2857|
|- NTR Number||NTR1126|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-nov-2007|
|- Secondary IDs||METC: 2006-262 ABR: 14260 EUDRACT:2006-004709-24 ErasmusMC|
|- Public Title||Myfortic in uveitis.|
|- Scientific Title||Mycophenolate sodium (Myfortic®) in the Treatment of Uveitis: a Pilot Study.|
|- ACRONYM||Myforic in Uveitis|
|- hypothesis||At least comparable therapeutic efficacy of Myfortic as compared to ciclosporin in therapy refractory uveitis.|
|- Healt Condition(s) or Problem(s) studied||Uveitis|
|- Inclusion criteria||1. Eligible patients with uveitis not responding to steroids due to:|
a. Ocular sarcoidosis;
b. Intermediate uveitis;
c. Behçet’s syndrome;
d. Idiopathic Retinal Vasculitis;
f. Vogt-Koyanagi-Harada disease;
g. Sympathetic ophthalmia;
h. Idiopathic panuveitis;
2. No systemic immunomodulatory agents other than steroids;
3. Significant flare requiring intensification of therapy (prednisone);
4. Visual acuity of 0.1 or better in at least one eye;
5. Adequate birth control measures;
6. The screening laboratory:
● Hemoglobin ≥ 6.5 mmol/L;
● WBC ≥ 3.0 x 109/L;
● Neutrophils ≥ 1.5 x 109/L;
● Platelets ≥ 100 x 109/L;
● SGOT and AF < 3 x ULN;
● Creatinine clearance > 20 ml/min;
7. Normal chest X-ray < 3 months;
8. Ability to adhere to the study visit schedule andprotocol requirements;
9. Capability of giving informed consent.
|- Exclusion criteria||1. Inability to visualize the fundus;|
2. Ocular surgery < 3 months of treatment;
3. Women who are pregnant, nursing, or planning pregnancy < 6 months;
4. Investigational drugs < 1 month or < 5 x T½;
5. Systemic immunosuppressive therapy, other than steroids for ocular disease;
6. Creatinine clearance of < 20ml/min;
7. Hypersensitivity to prednisone, cyclosporine, or Myfortic®;
8. Clinically significant infection;
9. Documented HIV infection;
10. Patients with active TB or evidence of latent TB;
11. Positive Lues serology and or significant Lues infection;
12. Oportunistic infections < 6 months;
13. Current signs or symptoms of severe organic disease;
14. Transplanted organ (except corneal transplant);
15. Malignancy < 5 years (except squamous or basal cell carcinoma of the skin);
16. Lymphoproliferative disease;
17. Substance abuse (drugs or alcohol);
18. Poor tolerability of venipuncture or lack of adequate venous access;
19. Recent live vaccinations.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||20-sep-2007|
|- planned closingdate||31-dec-2008|
|- Target number of participants||24|
|- Interventions||Treament with registered medication:|
3 months of 1 mg/kg/d prednisone in tapering schedule + ciclosporine twice daily total 5mg/kg/d compared with same amount of prednisone + 720mg mycophenolaat sodium (Myfortic) twice daily. Hereafter 9 months of follow-up.
|- Primary outcome||Total dose of prednisone.|
|- Secondary outcome||Inflammatoir response (cells and haze):|
● Cystoid macular oedeem;
● Inflammatoire markers;
● Adverse effects;
● Tijd tot relapse.
|- Timepoints||Week 0, 2, 4, 8, 12, 16, 28, 40, 52.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| J.A.M. Laar van|
|- CONTACT for SCIENTIFIC QUERIES|| J.A.M. Laar van|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Title of the study:|
Mycophenolate sodium (Myfortic) in the Treatment of Uveitis: a Pilot Study.
Background of the study:
Uveitis is a potentially sight threatening intraocular inflammation and responsible for 10 to 15% of patients with blindness. Non-infectious posterior uveitis is a presumed antigen-specific CD4+ T-lymphocyte–mediated autoimmune disease characterized by T-lymphocyte –and macrophage-induced and TNF-alpha mediated eye damage. Other cytokines involved in uveitis include IFN-γ, IL-1, 2, 5, 6, 10, 15, and TGF-β.
The T-cell inhibiting corticosteroids form the mainstay of immunoregulatory treatment in non-infectious uveitis. The second line drug of choice is cyclosporine, which exerts T-cell inhibitory actions. Its use may be limited by side effects such as impairment of the renal function, gastrointestinal complaints and hypertension.
Mycophenolate mofetil (MMF) inhibits the replication of T- and B-cells and also inhibits the local IL-15 dependent TNF formation. It is proven effective in patients with renal transplants, autoimmune diseases and uveitis. Side effects are relatively mild and seen in 10-30%. The enteric-coated formulation of mycophenolate sodium (EC-MPS, Myfortic®) is developed to overcome these side effects and is also proven effective in renal transplant recipients.
Objective of the study:
This study is designed to demonstrate equal therapeutic effect of Myfortic® as compared to MMF in this patient group, thus improving therapeutic efficacy.
Single blinded randomized phase 4 trial.
Steroid refractory patients with non-infetious uveitis older than 18 years.
Intervention (if applicable):
One group treated with Myfortic 720mg bid will be compared with ciclosporin 5 mg/kg/d in two doses.
Primary study parameters/outcome of the study:
Therapeutic equality between Myfortic® and cyclosporine:
1. Decrease of inflammatory response;
2. Improvement of BVCA;
Secundary study parameters/outcome of the study (if applicable):
1. Cystoid macular edema;
2. A possible relation with Inflammatory markers with therapeutic efficacy;
3. Adverse effects;
4. Total amount of steroids;
5. Time to relapse.
|- Main changes (audit trail)|
|- RECORD||2-nov-2007 - 3-apr-2008|