E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Test the hypotheses that in patients being treated with prednisolone for active Thyroid Eye Disease: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. |
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E.2.2 | Secondary objectives of the trial |
To establish the Psychosocial and Health Economic effects of Orbital Radiotherapy and Combined Immunosuppression in the treatment of active Thyroid Eye Disease |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Clinical Activity Score > or = 4; Worst Eye OR OR �?� 2 (worst eye) with a history of proptosis or motility restriction of less than 6 months duration2.Past or present history of abnormal Thyroid Gland Function OR a clinical diagnosis of TED made and confirmed by �?� 2 muscle involvement on CT or MRI scan |
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E.4 | Principal exclusion criteria |
1. Age <20 or >75 yrs2. Use of radioiodine within the last 3 months3. Preexisting diabetes mellitus (not simply steroid induced disease from recent therapy)4. Contraindication to either prednisolone or azathioprine5.Thiopurine Methyltransferase (TPMT) inactivity6.Clinical Activity Score > 4 without proptosis or motility restriction(Patients who do not improve with steroid treatment in the first month after enrolment will leave the trial and not be randomised) |
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E.5 End points |
E.5.1 | Primary end point(s) |
SHORT-TERM (6 weeks after radiotherapy): Clinical Activity Score (CAS)LONG-TERM (1 year) Composite Binary Clinical Outcome Measure (Treatment Response) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
SHORT-TERM (6 weeks after radiotherapy): Clinical Activity Score (CAS)LONG-TERM (1 year) Composite Binary Clinical Outcome Measure (Treatment Response) |
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E.5.2 | Secondary end point(s) |
SHORT-TERM (6 weeks after radiotherapy): Clinical Activity Score (CAS)LONG-TERM (1 year) Composite Binary Clinical Outcome Measure (Treatment Response) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
SHORT-TERM (6 weeks after radiotherapy): Clinical Activity Score (CAS)LONG-TERM (1 year) Composite Binary Clinical Outcome Measure (Treatment Response) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |