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Remission Induction and Sustenance in Graves' Disease 2

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ClinicalTrials.gov Identifier: NCT00796913
Recruitment Status : Unknown
Verified January 2015 by Peter Laurberg, Aalborg Universitetshospital.
Recruitment status was:  Active, not recruiting
First Posted : November 24, 2008
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):

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
Graves Disease Hyperthyroidism Other: Stop medication

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  (Clinical Trial)
Estimated Enrollment : 250 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
Study Start Date : January 2008
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperthyroidism
U.S. FDA Resources

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 Name: 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 Name: stop medication + se supplement


Outcome Measures

Primary Outcome Measures :
  1. Relapse of hyperthyroidism [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Reoccurrence of TSH-receptor autoimmunity [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Graves hyperthyroidism in remission after ATD

Exclusion Criteria:

  • Age < 18, severe concomitant disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00796913


Sponsors and Collaborators
Aalborg Universitetshospital
Investigators
Principal Investigator: Peter Laurberg, MD Aalborg Universitetshospital
More Information

Responsible Party: Peter Laurberg, Professor of Endocrinology and Internal medicine, Aalborg Universitetshospital
ClinicalTrials.gov Identifier: NCT00796913     History of Changes
Other Study ID Numbers: RISG2
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: January 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Graves Disease
Hyperthyroidism
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases