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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stop of medication after remission | Active Comparator | 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. |
|
| Medication for 2 yrs after remission | No Intervention | 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. | |
| Se-yeast 200 Microgr/day + arm A | Experimental | Additional arm where patients have been taking Se supplements during RISG1 therapy, and for 2 years after ATD withdrawal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stop medication | Other | Stop medication Stop medication + se supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse of hyperthyroidism | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Reoccurrence of TSH-receptor autoimmunity | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesper S Karmisholt, MD, Ph.D | Aalborg University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30719273 | Derived | Karmisholt J, Andersen SL, Bulow-Pedersen I, Carle A, Krejbjerg A, Nygaard B. Predictors of Initial and Sustained Remission in Patients Treated with Antithyroid Drugs for Graves' Hyperthyroidism: The RISG Study. J Thyroid Res. 2019 Jan 3;2019:5945178. doi: 10.1155/2019/5945178. eCollection 2019. |
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| ID | Term |
|---|---|
| D006111 | Graves Disease |
| D006980 | Hyperthyroidism |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
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| D013959 |
| Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |