Overview

This trial is active, not recruiting.

Conditions graves disease, hyperthyroidism
Treatment stop medication
Sponsor Aalborg Universitetshospital
Start date January 2008
End date October 2017
Trial size 250 participants
Trial identifier NCT00796913, RISG2

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(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.
stop medication stop medication + se supplement
Stop medication Stop medication + se supplement
(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.
(Experimental)
Additional arm where patients have been taking Se supplements during RISG1 therapy, and for 2 years after ATD withdrawal.
stop medication stop medication + se supplement
Stop medication Stop medication + se supplement

Primary Outcomes

Measure
Relapse of hyperthyroidism
time frame: 2 years

Secondary Outcomes

Measure
Reoccurrence of TSH-receptor autoimmunity
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Prospective Randomized Study of Therapy Withdrawal vs Continued Low Dose Medical Therapy in Patients With Graves' Disease Entering Remission During ATD Therapy
Principal investigator Peter Laurberg, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Aalborg Universitetshospital.