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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01885533
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: June 25, 2013    Key Record Dates
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