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Remission Induction and Sustenance in Graves' Disease 2

Primary Purpose

Graves Disease, Hyperthyroidism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stop medication
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Graves Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Graves hyperthyroidism in remission after ATD

Exclusion Criteria:

  • Age < 18, severe concomitant disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    No Intervention

    Experimental

    Arm Label

    Stop of medication after remission

    Medication for 2 yrs after remission

    Se-yeast 200 Microgr/day + arm A

    Arm 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.

    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.

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

    Outcomes

    Primary Outcome Measures

    Relapse of hyperthyroidism

    Secondary Outcome Measures

    Reoccurrence of TSH-receptor autoimmunity

    Full Information

    First Posted
    November 21, 2008
    Last Updated
    January 9, 2019
    Sponsor
    Aalborg University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00796913
    Brief Title
    Remission Induction and Sustenance in Graves' Disease 2
    Official Title
    Prospective Randomized Study of Therapy Withdrawal vs Continued Low Dose Medical Therapy in Patients With Graves' Disease Entering Remission During ATD Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 7, 2008 (Actual)
    Primary Completion Date
    May 15, 2015 (Actual)
    Study Completion Date
    May 15, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aalborg University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Graves Disease, Hyperthyroidism

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    139 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stop of medication after remission
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Medication for 2 yrs after remission
    Arm Type
    No Intervention
    Arm 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.
    Arm Title
    Se-yeast 200 Microgr/day + arm A
    Arm Type
    Experimental
    Arm Description
    Additional arm where patients have been taking Se supplements during RISG1 therapy, and for 2 years after ATD withdrawal.
    Intervention Type
    Other
    Intervention Name(s)
    Stop medication
    Other Intervention Name(s)
    stop medication + se supplement
    Intervention Description
    Stop medication Stop medication + se supplement
    Primary Outcome Measure Information:
    Title
    Relapse of hyperthyroidism
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Reoccurrence of TSH-receptor autoimmunity
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Graves hyperthyroidism in remission after ATD Exclusion Criteria: Age < 18, severe concomitant disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jesper S Karmisholt, MD, Ph.D
    Organizational Affiliation
    Aalborg University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30719273
    Citation
    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.
    Results Reference
    derived

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    Remission Induction and Sustenance in Graves' Disease 2

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