Post-Radioiodine Graves' Management: The PRAGMA-Study
PRAGMA
POST-RADIOIODINE GRAVES' MANAGEMENT
1 other identifier
observational
803
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedFirst Posted
Study publicly available on registry
June 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 30, 2017
March 1, 2017
1.9 years
February 15, 2013
March 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK
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.
12 months post radio-iodine
Secondary Outcomes (4)
Graves orbitopathy
12 months post-radiodiodine
weight gain
12 months
progression of Graves' orbitopathy
12 months
patient satisfaction
12 months
Study Arms (3)
Post-radioiodine medication
Anti-thyroid drugs
Post-radioiodine medications
anti-thyroid drugs and thyroxine
Post-radiodione medication
watchful monitoring
Eligibility Criteria
Adult patients with a history of Graves' disease treated with radioiodine
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, England, NE3 4HD, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2013
First Posted
June 25, 2013
Study Start
March 1, 2013
Primary Completion
February 1, 2015
Study Completion
December 1, 2015
Last Updated
March 30, 2017
Record last verified: 2017-03