Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease
ISRCTN | ISRCTN22471573 |
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DOI | https://doi.org/10.1186/ISRCTN22471573 |
Secondary identifying numbers | N/A |
- Submission date
- 25/01/2006
- Registration date
- 01/02/2006
- Last edited
- 14/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Richard Lee
Scientific
Scientific
Department of Clinical Sciences
Bristol Eye Hospital
Lower Maudlin street
Bristol
BS1 2LX
United Kingdom
Study information
Study design | Factorial randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Participant information sheet | Patient information can be found at: http://www.cirted.org/patients.htm |
Scientific title | Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease |
Study acronym | CIRTED |
Study objectives | Primary hypotheses: To test the following hypotheses in patients being treated with prednisolone for active Thyroid Eye Disease (TED): 1. Radiotherapy (compared with placebo) induces early remission and reduces long-term disease severity 2. Combined systemic immunosuppression with oral azathioprine (compared with placebo) reduces long-term disease severity Secondary hypotheses: 1. To test the hypothesis that patients being treated with prednisolone for active TED, using radiotherapy and combined systemic immunosuppression with oral azathioprine, can improve patient-centred outcomes and quality of life scores 2. To validate the use of a new TED specific quality of life score in the UK population 3. To improve understanding of the extent and type of psychosocial distress experienced by TED patients 4. To conduct an economic evaluation of the cost of TED and its treatment to patients, the NHS and Society 5. To compare treatments using health-economic analysis 6. To report the safety and tolerability of combined systemic immunosuppression with oral azathioprine in TED patients |
Ethics approval(s) | Central & South Bristol Research Ethics Committe (reference: 05/Q2006/62), approval gained 5th May 2005 (amendment to inclusion and exclusion criteria approved on the 2nd June 2006). |
Health condition(s) or problem(s) studied | Thyroid Eye Disease (TED) |
Intervention | All the patients receive six months of oral prednisolone and then are randomly assigned to receive one of the following interventions: 1. Radiotherapy and azathioprine 2. Radiotherapy and placebo 3. Azathioprine and placebo 4. Control: placebo and placebo |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Azathioprine |
Primary outcome measure | Primary: 1. Binary composite clinical outcome measure 2. Ophthalmopathy index Co-primary outcome measure: 1. Clinical activity score |
Secondary outcome measures | 1. Total Eye Score (TES) 2. Hospital Anxiety and Depression Scale (HADS) score 3. Derriford Appearance scale-short form score 4. Graves Ophthalmopathy Quality of Life (GO-QoL) score 5. World Health Organisation Brief Quality of Life (WHOQoL) assessment score 6. Open-ended responses to interview questions 7. Health economic measures |
Overall study start date | 01/01/2006 |
Completion date | 01/12/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 100 |
Key inclusion criteria | 1. Mourits' Clinical Activity Score more than or equal to four (worst eye) or more than two (worst eye) with a history of proptosis (defined as either subjective unilateral proptosis confirmed by asymmetry in exophthalmometry of more than 2 mm or subjective bilateral proptosis) or motility restriction (defined as intermittent, inconstant or constant diplopia grade) which is less than six months long 2. Past or present history of abnormal Thyroid Gland Function (TGF) or a clinical diagnosis of TED made and confirmed by more than two muscle involvement on Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan plus a history of recent onset motility restriction and/or proptosis |
Key exclusion criteria | 1. Age less than 20 or greater than 75 years 2. Optic neuropathy 3. Mourits Clinical Activity Score more than four without proptosis or motility restriction 4. Pre-existing glaucoma with a characteristic optic disc appearance and associated visual field defect 5. Use of radioiodine within the last three months 6. Pre-existing diabetes mellitus (not simply steroid-induced disease from recent therapy) 7. Previous adverse event associated with, or contraindication to, either prednisolone or azathioprine 8. Within six months of pregnancy, women planning pregnancy 9. Lactation 10. Haemoglobin concentration, total white cell count or platelet count below the local laboratory's reference range 11. Low, intermediate or high Thiopurine Methyltransferase (TPMT) activity 12. Lymphocyte count less than 0.8 x 10^9/l 13. Abnormal renal function (assessed by urea and creatinine levels above the local laboratorys reference range) 14. Abnormal liver function, specifically: bilirubin, alanine aminotransferase or alkaline phosphatase concentrations above the local laboratorys reference range 15. Malignant or pre-malignant (dysplastic) condition within the past five years 16. Previous tuberculosis 17. Shingles within the past three months 18. Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) 19. Concurrent use of: a. Other immunosuppressive or cytotoxic agents b. Allopurinol 20. Live vaccines within the past three months 21. Previous orbital irradiation |
Date of first enrolment | 01/01/2006 |
Date of final enrolment | 01/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Clinical Sciences
Bristol
BS1 2LX
United Kingdom
BS1 2LX
United Kingdom
Sponsor information
University of Bristol (UK)
University/education
University/education
Research & Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
https://ror.org/0524sp257 |
Funders
Funder type
Research organisation
The National Eye Research Centre, Bristol (UK)
No information available
Special trustees of Moorfields Eye Hospital (UK)
No information available
The Charitable Trusts for the United Bristol Hospitals (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | protocol | 31/01/2008 | Yes | No | |
Results article | results | 01/04/2018 | Yes | No |
Editorial Notes
14/02/2018: Publication reference added.