Treat-to-Target thyroid-stimulating hormone receptor antibody (TRAb) in Graves’ Disease

Comparing risk of relapse in Graves' disease patients treated with fixed-time carbimazole vs. treatment guided by TRAb titre

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000362594

Enrollment

Registered

2015-04-21

Start date

2015-06-16

Completion date

2016-09-06

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This is a pilot, single blinded randomised controlled trial assessing whether a treat-to-target TRAb approach with anti-thyroid drugs (carbimazole) results in lower risk of relapse of hyperthyroidism after treatment cessation in Graves' disease patients, compared with standard fixed length care. In addition, this trial will provide estimates of changes in quality of life, health care utilisation, and assess feasibility of recruitment. It will provide data for a sample size calculation for a properly powered randomised controlled trial.

Interventions

Treatment with oral carbimazole (variable dose to achieve euthyroidism; 2.5-60 mg daily) with length of treatment based on TRAb (Thyroid stimulating hormone receptor antibody) titre, performed 3-monthly on blood serum testing. This is a pilot, single blinded randomised controlled trial assessing whether a treat-to-target TRAb approach with anti-thyroid drugs (carbimazole to achieve euthyroidism, continued until 6 months after TRAb resolution) results in lower risk of relapse of hyperthyroidism after treatment cessation, compared with standard therapy (defined below). In addition, this trial will provide estimates of changes in quality of life, health care utilisation, and assess feasibility of recruitment. It will provide data for a sample size calculation for a properly powered randomised controlled trial.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

First presentation of Graves’ disease as defined as hyperthyroidism (free T4 and/or free T3 above the upper limit of normal with TSH suppressed below the lower limit of normal - <0.3mU/L) associated with elevated TSH-receptor antibody (TRAb) (>1.5 U/mL)

Exclusion criteria

- Greater than three months since first diagnosis of Graves’ disease - Age less than 18 years - Current or planned pregnancy within the next three years - Current breastfeeding - Clinical or imaging suspicion of thyroid cancer - TRAb negative status at time of diagnosis, - Potential participant or treating physician desire primary treatment with surgery or radioiodine therapy - Concomitant treatment with lithium, corticosteroids, amiodarone, Lugol’s iodine

Outcome results