Remission Induction and Sustenance in Graves' Disease 2

NCT ID: NCT00796913

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-07

Study Completion Date

2015-05-15

Brief Summary

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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

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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.

Conditions

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Graves Disease Hyperthyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Stop medication

Intervention Type OTHER

Stop medication Stop medication + se supplement

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Stop medication

Intervention Type OTHER

Stop medication Stop medication + se supplement

Interventions

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Stop medication

Stop medication Stop medication + se supplement

Intervention Type OTHER

Other Intervention Names

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stop medication + se supplement

Eligibility Criteria

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Inclusion Criteria

* Graves hyperthyroidism in remission after ATD

Exclusion Criteria

* Age \< 18, severe concomitant disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jesper Scott Karmisholt

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jesper S Karmisholt, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

References

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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.

Reference Type DERIVED
PMID: 30719273 (View on PubMed)

Other Identifiers

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RISG2

Identifier Type: -

Identifier Source: org_study_id

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