- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00796913
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Graves hyperthyroidism in remission after ATD
Exclusion Criteria:
- Age < 18, severe concomitant disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
Stop medication Stop medication + se supplement
Other Names:
|
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.
|
Stop medication Stop medication + se supplement
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relapse of hyperthyroidism
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reoccurrence of TSH-receptor autoimmunity
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jesper S Karmisholt, MD, Ph.D, Aalborg University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RISG2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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