Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial.

2.50
Hdl Handle:
http://hdl.handle.net/10541/58719
Title:
Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial.
Authors:
Rajendram, Rathie; Lee, Richard W J; Potts, Mike J; Rose, Geoff E; Jain, Rajni; Olver, Jane M; Bremner, Fion; Hurel, Steven; Cook, Anne; Gattamaneni, Rao; Tomlinson, Marjorie; Plowman, Nicholas; Bunce, Catey; Hollinghurst, Sandra P; Kingston, Laura; Jackson, Sue; Dick, Andrew D; Rumsey, Nichola; Morris, Olivia C; Dayan, Colin M; Uddin, Jimmy M
Abstract:
ABSTRACT: BACKGROUND: 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.The Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease (CIRTED) trial was designed to investigate the efficacy of radiotherapy and azathioprine in combination with a standard course of oral prednisolone in patients with active thyroid eye disease. METHODS/DESIGN: Patients with active thyroid eye disease will be randomised to receive (i) azathioprine or oral placebo and (ii) radiotherapy or 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. DISCUSSION: 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. TRIAL REGISTRATION: Current controlled trials ISRCTN22471573.
Affiliation:
Department of Clinical Science at South Bristol, University of Bristol, UK. richard.lee@bristol.ac.uk.
Citation:
Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial. 2008, 9:6 Trials
Journal:
Trials
Issue Date:
2008
URI:
http://hdl.handle.net/10541/58719
DOI:
10.1186/1745-6215-9-6
PubMed ID:
18237441
Type:
Article
Language:
en
ISSN:
1745-6215
Appears in Collections:
All Christie Publications ; Clinical Oncology

Full metadata record

DC FieldValue Language
dc.contributor.authorRajendram, Rathie-
dc.contributor.authorLee, Richard W J-
dc.contributor.authorPotts, Mike J-
dc.contributor.authorRose, Geoff E-
dc.contributor.authorJain, Rajni-
dc.contributor.authorOlver, Jane M-
dc.contributor.authorBremner, Fion-
dc.contributor.authorHurel, Steven-
dc.contributor.authorCook, Anne-
dc.contributor.authorGattamaneni, Rao-
dc.contributor.authorTomlinson, Marjorie-
dc.contributor.authorPlowman, Nicholas-
dc.contributor.authorBunce, Catey-
dc.contributor.authorHollinghurst, Sandra P-
dc.contributor.authorKingston, Laura-
dc.contributor.authorJackson, Sue-
dc.contributor.authorDick, Andrew D-
dc.contributor.authorRumsey, Nichola-
dc.contributor.authorMorris, Olivia C-
dc.contributor.authorDayan, Colin M-
dc.contributor.authorUddin, Jimmy M-
dc.date.accessioned2009-04-01T23:22:23Z-
dc.date.available2009-04-01T23:22:23Z-
dc.date.issued2008-
dc.identifier.citationProtocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial. 2008, 9:6 Trialsen
dc.identifier.issn1745-6215-
dc.identifier.pmid18237441-
dc.identifier.doi10.1186/1745-6215-9-6-
dc.identifier.urihttp://hdl.handle.net/10541/58719-
dc.description.abstractABSTRACT: BACKGROUND: 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.The Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease (CIRTED) trial was designed to investigate the efficacy of radiotherapy and azathioprine in combination with a standard course of oral prednisolone in patients with active thyroid eye disease. METHODS/DESIGN: Patients with active thyroid eye disease will be randomised to receive (i) azathioprine or oral placebo and (ii) radiotherapy or 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. DISCUSSION: 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. TRIAL REGISTRATION: Current controlled trials ISRCTN22471573.en
dc.language.isoenen
dc.subjectThyroid Eye Diseaseen
dc.subjectRandomized Controlled Trialen
dc.subjectRadiotherapyen
dc.titleProtocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial.en
dc.typeArticleen
dc.contributor.departmentDepartment of Clinical Science at South Bristol, University of Bristol, UK. richard.lee@bristol.ac.uk.en
dc.identifier.journalTrialsen

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