Use of Simvastatin as a Steroid Sparing Agent for Uveitis Patients

NCT02252328 | Unknown Phase 2 DMC

• 2 other identifiers: 14/01722014-003119-13
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uveitis

Keywords

Uveitis; Simvastatin; Visual acuity; Corticosteroids; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

  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

Study Arms (2)

Simvastatine

EXPERIMENTAL

Group of patients receiving simvastatin 80mg once daily in addition to standard care

Drug: Simvastatin

Placebo

PLACEBO COMPARATOR

Group of patients receiving placebo once daily in addition to standard care

Drug: Placebo

Interventions

Simvastatin DRUG

Simvastatin 80mg once daily

Simvastatine

Placebo DRUG

Placebo tablets once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be \>18 years and under 80 years.
• Both sexes may participate, but, because of possible teratogenicity of simvastatin women may do so only following counselling about the need for adequate contraception.
• Women of child bearing potential will have to have a negative pregnancy test prior to enrolment.
• Patients must have been previously diagnosed with intermediate, posterior or panuveitis (as defined by the standardization of uveitis nomenclature group).14
• Patients must be taking systemic prednisolone 10mg once daily or more.
• Patients may be treated with or without a second line agent.
• Patients must be willing and able to provide informed consent

You may not qualify if:

• No associated underlying systemic disease causing the uveitis.
• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment.
• Females must not be breastfeeding.
• Patients concomitantly taking ciclosporin, fibrates, amiodarone, amlodipine, verapamil, cytochrome P450 3A4 inhibitors (e.g. itraconazole, ketoconazole, posaconazole, voriconazole), HIV protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin, nefazodone, gemfibrozil, danazol, fusidic acid, diltiazem or anti-coagulants.
• Patients will be advised not to drink grapefruit juice during the study.
• Family history of hereditary muscle disorders.
• Active Liver disease
• Severe renal insufficiency.
• Persistently elevated serum transaminases.
• Allergies to excipients of simvastatin and placebo
• Lactose intolerance
• Involvement in other clinical trials

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24655729 BACKGROUND

MeSH Terms

Conditions

Uveitis

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Oren Tomkins-Netzer, MD, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

• Sue Lightman, PhD,FRCOphth

  University College, London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 30, 2014
• Study Start: September 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2019
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)