Graves' DiseasePRAGMANCT01885533
Post-Radioiodine Graves' Management: The PRAGMA-Study
An observational study of Graves' Disease, run by Newcastle-upon-Tyne Hospitals NHS Trust at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves' Disease
- How many people
- 803 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a history of Graves' disease treated with radioiodine
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, England, NE3 4HD
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP
About this study
Official title: 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.
- Conditions
- Graves' Disease
- Keywords
- Graves' disease, radioiodine, thyroid, hypothyroidism, Graves' orbitopathy
- Medical subject headings
- Graves Disease, Thyroid Diseases, Hypothyroidism, Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-radioiodine medication | Anti-thyroid drugs | |
| Post-radioiodine medications | anti-thyroid drugs and thyroxine | |
| Post-radiodione medication | watchful monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post radio-iodine
Secondary outcomes (4)
Graves orbitopathy
Measured: 12 months post-radiodiodine
weight gain
Measured: 12 months
progression of Graves' orbitopathy
Measured: 12 months
patient satisfaction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiff and Vale University Health Board, Royal Devon and Exeter NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885533
- Sponsor's protocol ID
- 110269
- Acronym
- PRAGMA
- Status last verified
- Mar 2017
- First submitted
- 15 Feb 2013
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POST-RADIOIODINE GRAVES' MANAGEMENT
- ClinicalTrials.gov ID
- NCT01885533
- Acronym / sponsor ID
- PRAGMA / 110269
- Conditions
- Graves' Disease
- Keywords
- Graves' disease, radioiodine, thyroid, hypothyroidism, Graves' orbitopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Cardiff and Vale University Health Board, Royal Devon and Exeter NHS Foundation Trust
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post-radioiodine medication | – | –Anti-thyroid drugs |
| Post-radioiodine medications | – | –anti-thyroid drugs and thyroxine |
| Post-radiodione medication | – | –watchful monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a history of Graves' disease treated with radioiodine
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves' Disease, run by Newcastle-upon-Tyne Hospitals NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK (time frame: 12 months post radio-iodine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.