Can simvastatin significantly reduce the amount of immunosuppressive medication required by patients with sight threatening uveitis?

Phase 1

• Conditions: veitis; MedDRA version: 19.1 Level: PT Classification code 10062016 Term: Immunosuppression System Organ Class: 10021428 - Immune system disorders; MedDRA version: 19.1 Level: PT Classification code 10046851 Term: Uveitis System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-003119-13-GB
• Lead Sponsor: Joint Research Office- UC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-09
• Study Completion: 2018-07-20
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

1.Patients must be >18 years and under 80 years.
2.Both sexes may participate, but, because of possible teratogenicity of simvastatin women may do so only following counselling about the need for adequate contraception.
3.Women of child bearing potential will have to have a negative pregnancy test prior to enrolment.
4.Patients must have been previously diagnosed with intermediate, posterior or panuveitis (as defined by the standardization of uveitis nomenclature group).
5.Patients must be taking systemic prednisolone 10mg once daily or more.
6. Patients may be treated with or without a second line agent.
7.Patients must be willing and able to provide informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Females who are pregnant, planning pregnancy or breastfeeding.
2.Patients concomitantly taking ciclosporin, fibrates, amiodarone, amlodipine, verapamil, CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, voriconazole), HIV protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin, nefazodone, gemfibrozil, danazol, fusidic acid, niacin, colchicine, rifampicin, diltiazem, statins or anti-coagulants.
3.Patients drinking grapefruit juice during the study.
4.Family history of hereditary muscle disorders.
5.Active Liver disease
6.Severe renal insufficiency.
7.Documented persistently elevated serum transaminases.
8.Allergies to excipients of IMP and placebo
9.Lactose intolerance
10.Active involvement in other clinical trials

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified