Investigation of the efficacy of radiotherapy and azathioprine in combination with a standard course of steroids in patients with active thyroid eye disease

Phase 1

• Conditions: Thyroid Eye Disease; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2004-002547-27-GB
• Lead Sponsor: niversity of Bristol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-05
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: To establish the Psychosocial and Health Economic effects of Orbital Radiotherapy and Combined Immunosuppression in the treatment of active Thyroid Eye Disease;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);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)

Secondary Outcome Measures

Name	Time	Method
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);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)