This study is designed to demonstrate equal therapeutic effect of Myfortic® as compared to MMF in this patient group, thus improving therapeutic efficacy.
ID
Source
Brief title
Condition
- Ocular infections, irritations and inflammations
- Immune disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Therapeutic equality between Myfortic® and cyclosporine:
§ Decrease of inflammatory response.
§ Improvement of BVCA
Secondary outcome
Secondary endpoints
§ Cystoid macular edema.
§ A possible relation with Inflammatory markers with therapeutic efficacy
§ Adverse effects.
§ Total amount of steroids.
§ Time to relapse
Background summary
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.
Study objective
This study is designed to demonstrate equal therapeutic effect of Myfortic® as
compared to MMF in this patient group, thus improving therapeutic efficacy.
Study design
Single blinded randomized phase 3 trial
Intervention
One group treated with Myfortic 720mg bid will be compared with ciclosporin 5
mg/kg/d in two doses.
Study burden and risks
No additional risk or burden will be caused by participation with this study.
Medicines are registered for refractory autoimmune diseases and have been
extensively used in the past.
Additionally 3 small vials of blood will be taken when blood tests are done
during routine outpatient controles. There will not be any additional
outpatinets controles
DR MOLEWATERPLEIN 40
3055 RH ROTTERDAM
NL
DR MOLEWATERPLEIN 40
3055 RH ROTTERDAM
NL
Listed location countries
Age
Inclusion criteria
patients with steroid refractory non-infectious uveitis
Exclusion criteria
1. fundus not visualizable opacities.
2. requiring ocular surgery < 3 months of treatment, or surgery in the prior 3 months.
3. pregnancy , 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. History of systemic immunosuppressive therapy, other than steroids for ocular disease.
6. Creatinine clearance of < 20ml/min.
7. Patients with known hypersensitivity to prednisone, cyclosporine, Myfortic® or to 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 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.
12. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
13. Presence of a transplanted organ (with the exception of a corneal transplant 3 months prior to screening).
14. Malignancy within the past 5 years (except for treated squamous or basal cell carcinoma of the skin without evidence of recurrence).
15. 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.
16. Known recent substance abuse (drugs or alcohol).
17. Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.
18. Recent live vaccinations
19. Lues infection or serology
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-004709-24-NL |
| CCMO | NL14260.078.06 |