Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial
<p>Abstract</p> <p>Background</p> <p>Medical management of thyroid eye disease remains controversial due to a paucity of high quality evidence on long-term treatment outcomes. Glucocorticoids are known to be effective initially but have significant side-effects with lon...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2008-01-01
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| Series: | Trials |
| Online Access: | http://www.trialsjournal.com/content/9/1/6 |
| _version_ | 1811275919444148224 |
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| author | Kingston Laura Hollinghurst Sandra P Bunce Catey Plowman Nicholas Tomlinson Marjorie Gattamaneni Rao Cook Anne Hurel Steven Bremner Fion Jain Rajni Olver Jane M Rose Geoff E Potts Mike J Lee Richard WJ Rajendram Rathie Jackson Sue Dick Andrew D Rumsey Nichola Morris Olivia C Dayan Colin M Uddin Jimmy M |
| author_facet | Kingston Laura Hollinghurst Sandra P Bunce Catey Plowman Nicholas Tomlinson Marjorie Gattamaneni Rao Cook Anne Hurel Steven Bremner Fion Jain Rajni Olver Jane M Rose Geoff E Potts Mike J Lee Richard WJ Rajendram Rathie Jackson Sue Dick Andrew D Rumsey Nichola Morris Olivia C Dayan Colin M Uddin Jimmy M |
| author_sort | Kingston Laura |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Medical management of thyroid eye disease remains controversial due to a paucity of high quality evidence on long-term treatment outcomes. Glucocorticoids are known to be effective initially but have significant side-effects with long-term use and recrudescence can occur on cessation. Current evidence is conflicting on the efficacy of radiotherapy and non-steroid systemic immunosuppression, and the majority of previous studies have been retrospective, uncontrolled, small or poorly designed.</p> <p>The Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease (CIRTED) trial was designed to investigate the efficacy of radiotherapy and azathioprine in <it>combination </it>with a standard course of oral prednisolone in patients with <it>active </it>thyroid eye disease.</p> <p>Methods/design</p> <p>Patients with active thyroid eye disease will be randomised to receive (i) azathioprine <it>or </it>oral placebo and (ii) radiotherapy <it>or </it>sham-radiotherapy in this multi-centre, factorial randomised control trial. The primary outcome is improvement in disease severity (assessed using a composite binary measure) at 12 months and secondary end-points include quality of life scores and health economic measures.</p> <p>Discussion</p> <p>The CIRTED trial is the first study to evaluate the role of radiotherapy and azathioprine as part of a long-term, combination immunosuppressive treatment regime for Thyroid Eye Disease. It will provide evidence for the role of radiotherapy and prolonged immunosuppression in the management of this condition, as well as pilot data on their use in combination. We have paid particular attention in the trial design to establishing (a) robust placebo controls and masking protocols which are effective and safe for both radiotherapy and the systemic administration of an antiproliferative drug; (b) constructing effective inclusion and exclusion criteria to select for active disease; and (c) selecting pragmatic outcome measures.</p> <p>Trial registration</p> <p>Current controlled trials ISRCTN22471573</p> |
| first_indexed | 2024-04-12T23:46:05Z |
| format | Article |
| id | doaj.art-afc88f9344b24b7db38c31ddd325d536 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T23:46:05Z |
| publishDate | 2008-01-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj.art-afc88f9344b24b7db38c31ddd325d5362022-12-22T03:11:51ZengBMCTrials1745-62152008-01-0191610.1186/1745-6215-9-6Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trialKingston LauraHollinghurst Sandra PBunce CateyPlowman NicholasTomlinson MarjorieGattamaneni RaoCook AnneHurel StevenBremner FionJain RajniOlver Jane MRose Geoff EPotts Mike JLee Richard WJRajendram RathieJackson SueDick Andrew DRumsey NicholaMorris Olivia CDayan Colin MUddin Jimmy M<p>Abstract</p> <p>Background</p> <p>Medical management of thyroid eye disease remains controversial due to a paucity of high quality evidence on long-term treatment outcomes. Glucocorticoids are known to be effective initially but have significant side-effects with long-term use and recrudescence can occur on cessation. Current evidence is conflicting on the efficacy of radiotherapy and non-steroid systemic immunosuppression, and the majority of previous studies have been retrospective, uncontrolled, small or poorly designed.</p> <p>The Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease (CIRTED) trial was designed to investigate the efficacy of radiotherapy and azathioprine in <it>combination </it>with a standard course of oral prednisolone in patients with <it>active </it>thyroid eye disease.</p> <p>Methods/design</p> <p>Patients with active thyroid eye disease will be randomised to receive (i) azathioprine <it>or </it>oral placebo and (ii) radiotherapy <it>or </it>sham-radiotherapy in this multi-centre, factorial randomised control trial. The primary outcome is improvement in disease severity (assessed using a composite binary measure) at 12 months and secondary end-points include quality of life scores and health economic measures.</p> <p>Discussion</p> <p>The CIRTED trial is the first study to evaluate the role of radiotherapy and azathioprine as part of a long-term, combination immunosuppressive treatment regime for Thyroid Eye Disease. It will provide evidence for the role of radiotherapy and prolonged immunosuppression in the management of this condition, as well as pilot data on their use in combination. We have paid particular attention in the trial design to establishing (a) robust placebo controls and masking protocols which are effective and safe for both radiotherapy and the systemic administration of an antiproliferative drug; (b) constructing effective inclusion and exclusion criteria to select for active disease; and (c) selecting pragmatic outcome measures.</p> <p>Trial registration</p> <p>Current controlled trials ISRCTN22471573</p>http://www.trialsjournal.com/content/9/1/6 |
| spellingShingle | Kingston Laura Hollinghurst Sandra P Bunce Catey Plowman Nicholas Tomlinson Marjorie Gattamaneni Rao Cook Anne Hurel Steven Bremner Fion Jain Rajni Olver Jane M Rose Geoff E Potts Mike J Lee Richard WJ Rajendram Rathie Jackson Sue Dick Andrew D Rumsey Nichola Morris Olivia C Dayan Colin M Uddin Jimmy M Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial Trials |
| title | Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial |
| title_full | Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial |
| title_fullStr | Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial |
| title_full_unstemmed | Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial |
| title_short | Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial |
| title_sort | protocol for the combined immunosuppression radiotherapy in thyroid eye disease cirted trial a multi centre double masked factorial randomised controlled trial |
| url | http://www.trialsjournal.com/content/9/1/6 |
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