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Post-Radioiodine Graves' Management: The PRAGMA-Study (PRAGMA)
This study has been completed.
Sponsor:
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators:
Cardiff and Vale University Health Board
Royal Devon and Exeter NHS Foundation Trust
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01885533
First received: February 15, 2013
Last updated: March 29, 2017
Last verified: March 2017
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Purpose
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 |
|---|
| Graves' Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | POST-RADIOIODINE GRAVES' MANAGEMENT |
Resource links provided by NLM:
Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Primary Outcome Measures:
- 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:
- Graves orbitopathy [ Time Frame: 12 months post-radiodiodine ]
- weight gain [ Time Frame: 12 months ]
- progression of Graves' orbitopathy [ Time Frame: 12 months ]
- patient satisfaction [ Time Frame: 12 months ]
| Enrollment: | 803 |
| Study Start Date: | March 2013 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Post-radioiodine medication
Anti-thyroid drugs
|
|
Post-radioiodine medications
anti-thyroid drugs and thyroxine
|
|
Post-radiodione medication
watchful monitoring
|
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01885533
Please refer to this study by its ClinicalTrials.gov identifier: NCT01885533
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
| Responsible Party: | Newcastle-upon-Tyne Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01885533 History of Changes |
| Other Study ID Numbers: |
110269 |
| Study First Received: | February 15, 2013 |
| Last Updated: | March 29, 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 |
ClinicalTrials.gov processed this record on July 21, 2017