Remission Induction and Sustenance in Graves' Disease 2

Study Overview
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Brief Summary
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ATD therapy for Graves' disease is one of the commonly used options for therapy of the hyperthyroidism. The investigators study how to optimally keep patients in remission.

Detailed Description
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A detailed description of patients entering the initial observational phase of the study (RISG1) has been published: Laurberg P, Nygaard B, Andersen S, Carlé A, Karmisholt J, Krejbjerg A, Pedersen IB, Andersen SL. Association between TSH-Receptor Autoimmunity, Hyperthyroidism, Goitre, and Orbitopathy in 208 Patients Included in the Remission Induction and Sustenance in Graves' Disease Study. J Thyroid Res. 2014;2014:165487. doi: 10.1155/2014/165487.

Official Title
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Prospective Randomized Study of Therapy Withdrawal vs Continued Low Dose Medical Therapy in Patients With Graves' Disease Entering Remission During ATD Therapy

Conditions
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Graves Disease, Hyperthyroidism

Intervention / Treatment
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* Other: Stop medication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Graves hyperthyroidism in remission after ATD Exclusion Criteria: Age < 18, severe concomitant disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stop of medication after remission<br>After enetering remission patients are randomised to continue low dose medication or to stop medication: Overview of study described in: Laurberg P, Nygaard B, Andersen S, Carlé A, Karmisholt J, Krejbjerg A, Pedersen IB, Andersen SL. Association between TSH-Receptor Autoimmunity, Hyperthyroidism, Goitre, and Orbitopathy in 208 Patients Included in the Remission Induction and Sustenance in Graves' Disease Study. J Thyroid Res. 2014;2014:165487. doi: 10.1155/2014/165487. | Other: Stop medication<br>* Stop medication Stop medication + se supplement<br>* Other names: stop medication + se supplement;|
| No Intervention: Medication for 2 yrs after remission<br>See Laurberg P, Nygaard B, Andersen S, Carlé A, Karmisholt J, Krejbjerg A, Pedersen IB, Andersen SL. Association between TSH-Receptor Autoimmunity, Hyperthyroidism, Goitre, and Orbitopathy in 208 Patients Included in the Remission Induction and Sustenance in Graves' Disease Study. J Thyroid Res. 2014;2014:165487. doi: 10.1155/2014/165487. | |
| Experimental: Se-yeast 200 Microgr/day + arm A<br>Additional arm where patients have been taking Se supplements during RISG1 therapy, and for 2 years after ATD withdrawal. | Other: Stop medication<br>* Stop medication Stop medication + se supplement<br>* Other names: stop medication + se supplement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse of hyperthyroidism |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoccurrence of TSH-receptor autoimmunity |  | 2 years |