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

Combined Immunosuppression and Radiotherapy in Thyroid Eye Disease - CIRTED

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002547-27-GB

Enrollment

160

Registered

2005-08-05

Start date

2005-09-03

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Eye Disease

Interventions

Trade Name: azathioprine Product Name: Azathioprine Product Code: not applicable Pharmaceutical Form: Tablet CAS Number: 6336-41-0 Concentration unit: g gram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Age 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)

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
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)	—

Countries

United Kingdom

Contacts

Public ContactRichard Lee

University of Bristol

richard.lee@bristol.ac.uk+4401173312020

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026