Graves Disease
Conditions
Brief summary
To prospectively study the efficacy and safety of the Cook County Health (CCH) methimazole (MMI) dosing algorithm in the setting of new onset Graves' disease.
Detailed description
To conduct a prospective observational study in 60 patients with newly diagnosed Graves' disease who are either methimazole naive or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm and assess for efficacy and safety of MMI dosing administered. Study group size is based on 90% power and projected efficacy of 70% patients reaching target.
Interventions
DRUGMethimazole Tablets
Testing dosing algorithm for efficacy.
Sponsors
Cook County Health
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-pregnant adults (\>18 years of age) with new diagnosis of Graves' Disease (elevated free T4, Free T3, low or suppressed TSH, positive TSI and or thyroid eye disease) and * either drug naïve or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm.
Exclusion criteria
* Pregnant patients * hyperthyroidism due to other causes, example - Toxic Multinodular Goiter, Iodine induced thyrotoxicosis, etc. * Graves patients who present with atrial fibrillation, CHF or other end organ damage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of euthyroid state | 17 weeks | The proportion of patients achieving euthyroid state during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Factors influencing achievement of euthyroid state | 17 weeks | Identifying variables that correlate with achievement of euthyroid state |
Countries
United States
Outcome results
None listed