Remission Induction and Sustenance in Graves' Disease 2
Prospective Randomized Study of Therapy Withdrawal vs Continued Low Dose Medical Therapy in Patients With Graves' Disease Entering Remission During ATD Therapy
1 other identifier
interventional
139
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 7, 2008
CompletedFirst Submitted
Initial submission to the registry
November 21, 2008
CompletedFirst Posted
Study publicly available on registry
November 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2015
CompletedJanuary 10, 2019
January 1, 2019
7.4 years
November 21, 2008
January 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Relapse of hyperthyroidism
2 years
Secondary Outcomes (1)
Reoccurrence of TSH-receptor autoimmunity
2 years
Study Arms (3)
Stop of medication after remission
ACTIVE COMPARATORAfter 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 INTERVENTIONSee 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
EXPERIMENTALAdditional arm where patients have been taking Se supplements during RISG1 therapy, and for 2 years after ATD withdrawal.
Interventions
Stop medication Stop medication + se supplement
Eligibility Criteria
You may qualify if:
- Graves hyperthyroidism in remission after ATD
You may not qualify if:
- Age \< 18, severe concomitant disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 30719273DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesper S Karmisholt, MD, Ph.D
Aalborg University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 21, 2008
First Posted
November 24, 2008
Study Start
January 7, 2008
Primary Completion
May 15, 2015
Study Completion
May 15, 2015
Last Updated
January 10, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share