|
Welcome
|
|
10 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Tacrolimus monotherapy for uveitis |
| ISRCTN | ISRCTN46576063 |
| ClinicalTrials.gov identifier | |
| Public title | Tacrolimus monotherapy for uveitis |
| Scientific title | Dual steroid and tacrolimus therapy versus steroid withdrawal and tacrolimus therapy in the treatment of posterior segment intraocular inflammation (uveitis) |
| Acronym | N/A |
| Serial number at source | OP/2004/1733 |
| Study hypothesis | Tacrolimus monotherapy is not inferior to tacrolimus and prednisolone for the maintenance of uveitis remission. |
| Lay summary | |
| Ethics approval | Ethics approval received from North Somerset and South Bristol Research Ethics Committee on the 8th March 2004 (ref: E5862). |
| Study design | Dual-centre, randomised, non-inferiority, open-label trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Uveitis |
| Participants - inclusion criteria |
Patients with sight-threatening non-infectious posterior intraocular inflammation (PSII) who:
1. Are unable to reduce their prednisone dose to less than 10 mg daily without disease relapse 2. Require recurrent high dose steroid rescue for recurrent relapsing disease 3. Have severe sight-threatening disease warranting immediate institution of combination immunotherapy (high dose prednisone and a second line agent) 4. Are greater than or equal to 18 years old, either sex, and able to give informed consent |
| Participants - exclusion criteria |
1. Pregnancy or lactation
2. Female patients of child bearing age who are unwilling or unable to maintain effective birth control during the study 3. Diabetes mellitus (except steroid induced) 4. Significant and unstable renal disease (creatinine outside the local laboratories reference range on two consecutive occasions) 5. Participating in another clinical trial or has been taking an investigational drug in the past 28 days 6. Unlikely to comply with the visits scheduled in the protocol 7. Live vaccinations within three months of study entry 8. Previous adverse event associated with, or contra-indication to, either prednisolone or tacrolimus 9. Concurrent use of other immunosuppressive or cytotoxic agents 10. Previous tuberculosis 11. Shingles within the past three months 12. Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), including current or previous history of opportunistic infections such as cytomegalovirus (CMV), active Pneumocystis carinii, atypical mycobacterium 13. Recent history of substance abuse (drug or alcohol) 14. Use of cyclosporin A within the last three months 15. Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous three months |
| Anticipated start date | 01/05/2004 |
| Anticipated end date | 01/12/2008 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 40 |
| Interventions |
1. Oral tacrolimus (target trough serum level 8 - 12 ng/ml) only
2. Oral tacrolimus (target trough serum level 8 - 12 ng/ml) and oral prednisolone (7.5 - 10 mg daily) Frequency of oral tacrolimus administration is the same for both trial arms. It is administered twice daily, however the oral dose prescribed to achieve the target serum levels varies from patient to patient. Treatment duration and follow-up are until study completion (i.e., nine months post randomisation), or withdrawal. |
| Primary outcome measure(s) | Change in logarithm of the minimum angle of resolution (LogMAR) visual acuity (VA) between randomisation and study completion or withdrawal. |
| Secondary outcome measure(s) |
1. Rate of study withdrawal post-randomisation due to either treatment inefficacy (disease reactivation) or intolerance
2. Change in the following measures of disease severity between randomisation and study completion or withdrawal: 2.1. Binocular indirect ophthalmoscopy score 2.2. Anterior chamber cell grade 2.3. Retinal vasculitis score 2.4. Grade of optic disc swelling 2.5. Chorioretinal infiltrate 3. Change in the following assessments of treatment tolerance between randomisation and study completion or withdrawal: 3.1. Rate of onset of hypocholesterolemia, hypoglycaemia, hypertension, hypomagnesaemia and greater than or equal to 30% increase in serum creatinine concentration 3.2. Rate of onset of adverse events - overall by system (e.g. nervous system) and by description (e.g. tremor) 3.3. Rate of increase in intraocular pressure (IOP) to greater than 24 mmHg 4. Proportion of patients withdrawn post-enrolment and pre-randomisation for treatment inefficacy or intolerance 5. Change in quality of life in 3, 6 and 12 months after study enrolment, as assessed by the 36-item short form health survey (SF-36) and vision core module 1 (VCM1) scores |
| Sources of funding |
1. Fujisawa Pharma Co Ltd (UK)
2. NHS R&D support funding (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Richard Lee |
| Address |
Academic Unit of Ophthalmology
Bristol Eye Hospital Lower Maudlin Street |
| City/town | Bristol |
| Zip/Postcode | BS1 2LX |
| Country | United Kingdom |
| Tel | +44 (0)117 928 4949 |
| Fax | +44 (0)117 925 1421 |
| richard.lee@bristol.ac.uk | |
| Sponsor | United Bristol Healthcare Trust (UK) |
| Address |
Research and Effectiveness Department
UBHT Education Centre, Level 3 Upper Maudlin Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8AE |
| Country | United Kingdom |
| Sponsor website: | http://www.ubht.nhs.uk/ |
| Date applied | 15/04/2008 |
| Last edited | 16/04/2008 |
| Date ISRCTN assigned | 16/04/2008 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|