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Completed

NCT Number: NCT01885533

Post-Radioiodine Graves' Management: The PRAGMA-Study

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.

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Key information

Conditions

Graves' Disease Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Hypothyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, England, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Other

Collaborators

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

Registry information

Official study title

POST-RADIOIODINE GRAVES' MANAGEMENT

Acronym: PRAGMA

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2013
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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