UveitisPhase 2/3NCT02252328
Use of Simvastatin as a Steroid Sparing Agent for Uveitis Patients
A Phase 2/3 study testing Simvastatin in people with Uveitis, run by University College, London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uveitis
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Aug 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Simvastatin Significantly Reduce the Amount of Immunosuppressive Medication Required by Patients With Sight Threatening Uveitis? A Phase 2b, Single Site, Randomized, Placebo Controlled, Double Blinded Trial.
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.
Read the detailed description
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.
- Conditions
- Uveitis
- Being tested
- Simvastatin, Placebo
- Keywords
- Uveitis, Simvastatin, Visual acuity, Corticosteroids, Immunosuppression
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Simvastatin 80mg once daily
PlaceboDrug
Placebo tablets once daily
| Study group | Role | What they receive |
|---|---|---|
| Simvastatine | Experimental | Group of patients receiving simvastatin 80mg once daily in addition to standard care Receives: Drug: Simvastatin |
| Placebo | Placebo comparator | Group of patients receiving placebo once daily in addition to standard care Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 12 months
Secondary outcomes (8)
The mean reduction in prednisolone achieved at 24 months.
Measured: 24 months
The chnage in the number of 2nd-line immunosuppressive drugs at 24 months
Measured: 24 months
The number of disease relapses by 24 months
Measured: 24 months
Blood cholesterol and lipid levels at 24 months as compared to baseline
Measured: 24 months
Change in visual acuity at 12 and 24 months as compared to baseline
Measured: 12 and 24 months
Treg and Th17 levels at 12 and 24 months as compared to baseline
Measured: 12 and 24 months
Number of patients with adverse events.
Measured: 24 months
The change in dose (mg) of 2nd-line immunosuppressive drugs at 24months
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startSep 2015
- Primary completionAug 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oren Tomkins-Netzer, MD, PhD, Principal investigator, University College, LondonSue Lightman, PhD,FRCOphth, Study chair, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252328
- Sponsor's protocol ID
- 14/0172
- Other IDs
- 2014-003119-13, 14/0172, 2014
- Status last verified
- Oct 2017
- First submitted
- 8 Sep 2014
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24655729
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Simvastatin Significantly Reduce the Amount of Immunosuppressive Medication Required by Patients With Sight Threatening Uveitis? A Phase 2b, Single Site, Randomized, Placebo Controlled, Double Blinded Trial.
- ClinicalTrials.gov ID
- NCT02252328
- Acronym / sponsor ID
- 14/0172
- Conditions
- Uveitis
- Keywords
- Uveitis, Simvastatin, Visual acuity, Corticosteroids, Immunosuppression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatine | Experimental | Drug: SimvastatinGroup of patients receiving simvastatin 80mg once daily in addition to standard care |
| Placebo | Placebo comparator | Drug: PlaceboGroup of patients receiving placebo once daily in addition to standard care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimvastatinSimvastatin 80mg once daily | Drug | Simvastatine |
| PlaceboPlacebo tablets once daily | Drug | Placebo |
Primary outcome
1. Change in dose (mg) of prednisolone after 12 months of treatment
Time frame: 12 months
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?
8 secondary outcomes
The mean reduction in prednisolone achieved at 24 months.
Time frame: 24 months
The chnage in the number of 2nd-line immunosuppressive drugs at 24 months
Time frame: 24 months
The number of disease relapses by 24 months
Time frame: 24 months
Blood cholesterol and lipid levels at 24 months as compared to baseline
Time frame: 24 months
Change in visual acuity at 12 and 24 months as compared to baseline
Time frame: 12 and 24 months
Treg and Th17 levels at 12 and 24 months as compared to baseline
Time frame: 12 and 24 months
Number of patients with adverse events.
Time frame: 24 months
The change in dose (mg) of 2nd-line immunosuppressive drugs at 24months
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Background: PubMed 24655729Chataway 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oren Tomkins-Netzer, MD, PhD principal investigator
University College, London
Sue Lightman, PhD,FRCOphth study chair
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Simvastatin in people with Uveitis, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Change in dose (mg) of prednisolone after 12 months of treatment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02252328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.