Remission Induction and Sustenance in Graves' Disease 2

Aalborg University Hospital

Status: Completed

Conditions: Hyperthyroidism; Graves Disease

Treatments: Other: Stop medication

Study type: Interventional

Funder types: Other

Identifiers

NCT00796913

RISG2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Graves hyperthyroidism in remission after ATD

Exclusion criteria

• Age < 18, severe concomitant disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

139 participants in 3 patient groups

Stop of medication after remission

Active Comparator group

Description:

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.

Treatment:

Other: Stop medication

Medication for 2 yrs after remission

No Intervention group

Description:

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 group

Description:

Additional arm where patients have been taking Se supplements during RISG1 therapy, and for 2 years after ATD withdrawal.

Treatment:

Other: Stop medication