Remission Induction and Sustenance in Graves' Disease 2

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Peter Laurberg, Aalborg Universitetshospital
ClinicalTrials.gov Identifier:
NCT00796913
First received: November 21, 2008
Last updated: January 13, 2015
Last verified: January 2015

November 21, 2008
January 13, 2015
January 2008
October 2015   (final data collection date for primary outcome measure)
Relapse of hyperthyroidism [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00796913 on ClinicalTrials.gov Archive Site
Reoccurrence of TSH-receptor autoimmunity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Graves Disease
  • Hyperthyroidism
Other: Stop medication
Stop medication Stop medication + se supplement
Other Names:
  • stop medication
  • stop medication + se supplement
  • 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.

    Intervention: Other: Stop medication
  • 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.
    Intervention: Other: Stop medication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
January 2016
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Graves hyperthyroidism in remission after ATD

Exclusion Criteria:

  • Age < 18, severe concomitant disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00796913
RISG2
Not Provided
Peter Laurberg, Aalborg Universitetshospital
Aalborg Universitetshospital
Not Provided
Principal Investigator: Peter Laurberg, MD Aalborg Universitetshospital
Aalborg Universitetshospital
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP