Post-Radioiodine Graves' Management: The PRAGMA-Study (PRAGMA)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Thyroid dysfunction following radioiodine for Graves' disease is common, potentially detrimental and avoidable. A variety of clinical strategies are employed in the post-radioiodine era util the patient is on a stable thyroid hormone replacement regimen, which include the use of anti-thyroid drugs, antithyroid drugs with thyroxine, early thyroxine replacement and watchful monitoring until the onset of hypothyroidism. Which of these is most effective in avoiding dysthyroidism, is unknown. This study aims to address this lack of evidence. It will focus on Graves' disease as this is the commonest cause of thyrotoxicosis and the commonest indication for RI therapy. It will provide an insight into potential strategies for improving important clinical outcomes.

Condition or disease
Graves' Disease

Study Design

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Study Type :	Observational
Actual Enrollment :	803 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	POST-RADIOIODINE GRAVES' MANAGEMENT
Study Start Date :	March 2013
Actual Primary Completion Date :	February 2015
Actual Study Completion Date :	December 2015

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Post-radioiodine medication; Anti-thyroid drugs
Post-radioiodine medications; anti-thyroid drugs and thyroxine
Post-radiodione medication; watchful monitoring

Outcome Measures

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Primary Outcome Measures :

1. Incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK [ Time Frame: 12 months post radio-iodine ]

   To compare the incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK:

   • anti-thyroid drugs before and /or after RI
   • anti-thyroid drugs with levothyroxine before and / or after RI
   • watchful monitoring post-RI and introduction of levothyroxine when needed.

Secondary Outcome Measures :

1. Graves orbitopathy [ Time Frame: 12 months post-radiodiodine ]
2. weight gain [ Time Frame: 12 months ]
3. progression of Graves' orbitopathy [ Time Frame: 12 months ]
4. patient satisfaction [ Time Frame: 12 months ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Population

Adult patients with a history of Graves' disease treated with radioiodine

Criteria

Inclusion Criteria:

• Out-patients 18 years of age or over, who have given written informed consent to participate in the study
• Diagnosed with Graves' disease
• Received radioiodine for treatment of Graves' disease
• Had a minimum of 12 months follow-up after RI
• Most recent RI dose 5 years ago or less at the time of enrollment

Exclusion Criteria:

• Patients unable to give informed consent
• Age 17 years or younger
• Cause of thyrotoxicosis other than Graves' disease
• Patients who have had more than one dose of radioiodine can only be included in the study once, using data pertaining to their most recent treatment episode.
• Patients who might not adequately understand verbal explanations or written information given in English, or who have special communication needs

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, England, United Kingdom, NE3 4HD
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE1 4LP

Sponsors and Collaborators

Newcastle-upon-Tyne Hospitals NHS Trust

Cardiff and Vale University Health Board

Royal Devon and Exeter NHS Foundation Trust

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:	NCT01885533 History of Changes
Other Study ID Numbers:	110269
First Posted:	June 25, 2013
Last Update Posted:	March 30, 2017
Last Verified:	March 2017

Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Graves' disease; radioiodine; thyroid; hypothyroidism; Graves' orbitopathy

Additional relevant MeSH terms:

Graves Disease; Exophthalmos; Orbital Diseases; Eye Diseases; Goiter	Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases