Post-Radioiodine Graves' Management: The PRAGMA-Study

Graves' Disease Clinical Trial

— PRAGMA  

Official title:

POST-RADIOIODINE GRAVES' MANAGEMENT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885533
• Other study ID #: 110269
• Status: Completed
• Phase: N/A
• First received: February 15, 2013
• Last updated: March 29, 2017
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 803
• Est. completion date: December 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graves Disease
• Graves' Disease

Locations

Country	Name	City	State
United Kingdom	Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle upon Tyne	England
United Kingdom	Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle upon Tyne

Sponsors (3)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust	Cardiff and Vale University Health Board, Royal Devon and Exeter NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Graves orbitopathy		12 months post-radiodiodine
Secondary	weight gain		12 months
Secondary	progression of Graves' orbitopathy		12 months
Secondary	patient satisfaction		12 months