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

March 29, 2017 updated by: Newcastle-upon-Tyne Hospitals NHS Trust

POST-RADIOIODINE GRAVES' MANAGEMENT

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

803

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months post radio-iodine

Secondary Outcome Measures

Outcome Measure
Time Frame
Graves orbitopathy
Time Frame: 12 months post-radiodiodine
12 months post-radiodiodine
weight gain
Time Frame: 12 months
12 months
progression of Graves' orbitopathy
Time Frame: 12 months
12 months
patient satisfaction
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Collaborators

Cardiff and Vale University Health Board
Royal Devon and Exeter NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (ESTIMATE)

June 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110269

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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