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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003119-13 | EudraCT Number | ||
| 14/0172 | Other Grant/Funding Number | The Moulton Trust |
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The trial will compare the effect on disease control and immunosuppression treatment of adding simvastatin 80mg once daily, over a follow-up and treatment period of 2 years. Patients will be randomised in a 1:1 fashion to standard treatment with placebo or standard treatment with the addition of simvastatin (80mg daily). They will be followed at 3 months intervals for 2 years with a primary end point of mean reduction in corticosteroid dosage at the 12 month follow-up visit.
This is a non-commercial trial to explore the effect of simvastatin 80mg od on the dose of corticosteroids and immunosuppression in patients with sight-threatening uveitis.
In order to detect a clinical effect the study is designed as a double blinded, parallel group, placebo-controlled, randomised trial. Double blinding will be achieved through the use of a placebo as well as a masked clinical assessor.
Based on the reported effect of simvastatin on brain atrophy among multi[le sclerosis patients after 12 months treatment, patients will receive treatment or placebo and will be treated and followed up for 24 months.
Patients randomised to simvastatin will receive a dose of 80mg od. There will be no dose escalation.
Patients will be reviewed every 3 months and will undergo a complete ophthalmic examination with treatment adjustment accordingly.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simvastatine | Experimental | Group of patients receiving simvastatin 80mg once daily in addition to standard care |
|
| Placebo | Placebo Comparator | Group of patients receiving placebo once daily in addition to standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | Simvastatin 80mg once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Change in dose (mg) of prednisolone after 12 months of treatment | To determine whether the mean reduction in prednisolone dosage achieved at 12 months is greater in the simvastatin group compared to the placebo treated group? | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The mean reduction in prednisolone achieved at 24 months. | 24 months | |
| The chnage in the number of 2nd-line immunosuppressive drugs at 24 months | 24 months | |
| The number of disease relapses by 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oren Tomkins-Netzer, MD, PhD | University College, London | Principal Investigator |
| Sue Lightman, PhD,FRCOphth | University College, London | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moorfields Eye Hospital | London | EC1V 2PD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24655729 | Background | Chataway J, Schuerer N, Alsanousi A, Chan D, MacManus D, Hunter K, Anderson V, Bangham CR, Clegg S, Nielsen C, Fox NC, Wilkie D, Nicholas JM, Calder VL, Greenwood J, Frost C, Nicholas R. Effect of high-dose simvastatin on brain atrophy and disability in secondary progressive multiple sclerosis (MS-STAT): a randomised, placebo-controlled, phase 2 trial. Lancet. 2014 Jun 28;383(9936):2213-21. doi: 10.1016/S0140-6736(13)62242-4. Epub 2014 Mar 19. |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Drug |
Placebo tablets once daily |
|
| 24 months |
| Blood cholesterol and lipid levels at 24 months as compared to baseline | 24 months |
| Change in visual acuity at 12 and 24 months as compared to baseline | 12 and 24 months |
| Treg and Th17 levels at 12 and 24 months as compared to baseline | 12 and 24 months |
| Number of patients with adverse events. | 24 months |
| The change in dose (mg) of 2nd-line immunosuppressive drugs at 24months | 24 months |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |