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Remission Induction and Sustenance in Graves' Disease 2

Sponsor
Aalborg University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00796913
Collaborator
(none)
139
Enrollment
3
Arms
88.2
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Stop medication
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
139 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Prospective Randomized Study of Therapy Withdrawal vs Continued Low Dose Medical Therapy in Patients With Graves' Disease Entering Remission During ATD Therapy
Actual Study Start Date :
Jan 7, 2008
Actual Primary Completion Date :
May 15, 2015
Actual Study Completion Date :
May 15, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Stop of medication after remission

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
Stop medication Stop medication + se supplement
Other Names:
  • stop medication + se supplement

    		•
    No Intervention: Medication for 2 yrs after remission

    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

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

    Other: Stop medication
    Stop medication Stop medication + se supplement
    Other Names:
  • stop medication + se supplement

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Relapse of hyperthyroidism [2 years]

    Secondary Outcome Measures

    1. Reoccurrence of TSH-receptor autoimmunity [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Graves hyperthyroidism in remission after ATD
    Exclusion Criteria:
    • Age < 18, severe concomitant disease

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Aalborg University Hospital

    Investigators

    • Principal Investigator: Jesper S Karmisholt, MD, Ph.D, Aalborg University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jesper Scott Karmisholt, MD, Aalborg University Hospital
    ClinicalTrials.gov Identifier:
    NCT00796913
    Other Study ID Numbers:
    • RISG2
    First Posted:
    Nov 24, 2008
    Last Update Posted:
    Jan 10, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Graves Disease
    Hyperthyroidism

    Study Results

    No Results Posted as of Jan 10, 2019