Thyroid Associated OphthalmopathyPhase 3NCT06392906
Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks (OraGO-1 Trial)
A Phase 3 study testing Short course radiation therapy and Standard course radiation therapy in people with Thyroid Associated Ophthalmopathy, run by Janjira Petsuksiri at 1 site in Thailand.
Trial summary
Thyroid ophthalmopathy, also known as thyroid eye disease or Graves' ophthalmopathy, is a condition characterized by inflammation and swelling of the tissues around the eyes, often accompanied by protrusion of the eyeballs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Associated Ophthalmopathy
- What is being tested?
- Short course radiation therapy and Standard course radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteThailand
- Study dates
- 11 Jul 2024to 31 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with active moderate to severe thyroid eye disease with a CAS > 4 with/ without diplopia before starting IVMP
- Patient with poor response to 3 doses of IVMP (CAS drop < 1) หรือ CAS score > 3 after 3 doses of IVMP
- Patients with diplopia after 3 doses of IVMP
- Patients with Graves' Ophthalmopathy who have maintained euthyroidism
- Non-pregnant adults (aged 35 years or older)
Who cannot join
- Individuals with severe hypertension or diabetic retinopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital Mahidol University
Bangkok Noi, 10700
Janjira Petsuksiri, M.D., 66919966662, janjira.pet@mahidol.ac.th
Wajana Thaweerat, M.D., 66941499212, wajana.thaweerat@gmail.com
About this study
Official title: Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks: A Phase II Randomized Controlled Trial (OraGO-1 Trial)
Thyroid ophthalmopathy, also known as thyroid eye disease or Graves' ophthalmopathy, is a condition characterized by inflammation and swelling of the tissues around the eyes, often accompanied by protrusion of the eyeballs. This condition can lead to significant discomfort, visual disturbances, and in severe cases, permanent vision loss.
Primary treatment modalities are intravenous methylprednisolone (IVMP) and other medications for patients with moderate to severe and active thyroid eye disease. In addition, external beam radiation therapy (ERT) is an another treatment option in combination with IVMP.
Read more
Radiation therapy delivers targeted doses of ionizing radiation to the affected orbital tissues, effectively reducing inflammation. This approach is particularly beneficial for patients who may not respond adequately to steroid therapy alone or those who experience recurrent disease flares.
This study will test the efficacy of a shortened treatment regimen comprising 5 sessions of ERT to a standard protocol of 10 treatments. The primary aim is to ascertain the effectiveness of shorted radiation treatment while improving patients' quality of life.
Read the detailed description
The research methodology of this study involves comparing the standard protocol of 10 radiation treatments with a modified approach comprising 5 treatments of daily External Beam Radiation Therapy (ERT).
The primary objective of this investigation is to assess whether reducing the number of radiation treatments while maintaining the effectiveness of the therapy can lead to improvements in the quality of life for patients with thyroid ophthalmopathy.
By comparing these two treatment regimens, researchers aim to evaluate the efficacy and safety of the abbreviated radiation schedule in managing the symptoms and progression of the disease.
Participants enrolled in the study will be randomized into two groups: one receiving the standard 10 treatments and the other receiving the modified 5-treatment regimen of daily ERT. Throughout the study period, participants will undergo comprehensive assessments to monitor changes in symptoms, vision, and quality of life. These evaluations will include ophthalmic examinations, imaging studies, and patient-reported outcome measures to capture both objective and subjective measures of treatment response.
- Conditions
- Thyroid Associated Ophthalmopathy
- Being tested
- Short course radiation therapy, Standard course radiation therapy
- Keywords
- radiation therapy
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short course radiation therapyRadiation
Also called 10 Gy in 5 fractions of radiation therapy
5 daily radiation treatments
Standard course radiation therapyRadiation
Also called 20 Gy in 10 fractions of radiation therapy
10 daily radiation treatments
| Study group | Role | What they receive |
|---|---|---|
| 1 week external beam radiation therapy | Experimental | 10 Gy in 5 fractions of external beam radiation therapy Receives: Radiation: Short course radiation therapy |
| 2 week external beam radiation therapy | Active comparator | 20 Gy in 10 fractions of standard fraction external beam radiation therapy Receives: Radiation: Standard course radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Activity Score (CAS) change
To evaluate the non-inferiority of outcomes in terms of the patient's proportion of converting from active (CAS > 4) to inactive eye disease (CAS <3) with CAS drop > 2 points, following orbital radiotherapy in combination with IVMP, comparing standard and reduced-dose orbital radiotherapy
CAS score range from 1-7, initially and range from 1-10 at 1-3 months follow-up period. Higher CAS scores represented worse outcomes.
Measured: 6 months after initiation of IVMP
Secondary outcomes (6)
muscle and retrobulbar fat volume change
To compare the change in volume of extra-ocular muscles and retro bulbar fat after orbital radiotherapy, comparing standard with reduced-dose orbital radiotherapy
Measured: 6 months after initiation of IVMP
change in diplopia
To compare the difference in prism deviation in primary gaze after standard and reduced-dose orbital radiotherapy
Measured: 6 months after initiation of IVMP
change in quality of life
To compare the difference in Graves' ophthalmopathy quality of life (GO-QOL) scores (Thai version) between standard and reduced-dose orbital radiotherapy. The total QOL scores range from 0 to 100 with higher scores indicating a better health status.
Measured: 6 months after initiation of IVMP
Radiation toxicities
To compare the summation of the Radiation Therapy Oncology Group (RTOG) toxicity scores (including dry eye, eye pain, keratitis, eyelid, conjunctiva, lacrimal gland, cornea, iris and skin toxicities) after standard and reduced-dose orbital radiotherapy. The RTOG gradings range from grade 0 to grade 4 in each item. The total toxicity scores range from 0-34, with a higher score indicating more severe side effects.
Measured: 6 months after initiation of IVMP
Visual acuity (VA)
-To compare the differences in visual acuity (logMAR) change after standard and reduced-dose orbital radiotherapy
Measured: 6 months after initiation of IVMP
Visual field (VF)
- To compare the differences of Humphrey's visual field (mean deviation) change after standard and reduced-dose orbital radiotherapy
Measured: 6 months after initiation of IVMP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start11 Jul 2024
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Thyroid Associated OphthalmopathyStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 2 randomized control trial comparing between standard radiation therapy arm (20 Gy in 10 fractions) and experimental radiation therapy arm (10 Gy in 5 fractions)
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janjira Petsuksiri
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Responsible party
- Sponsor-investigator, Janjira Petsuksiri, Mahidol University
- Investigators
- Janjira Petsuksiri, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392906
- Sponsor's protocol ID
- SI208/2024
- Status last verified
- Dec 2024
- First submitted
- 30 Mar 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) may include sensitive information about participants, such as medical history or demographic details, particularly regarding their quality of life. Sharing IPD will be conducted in accordance with Siriraj Institutional Review Board (IRB) regulations for personal data protection."
Publications
Hoang TD, Stocker DJ, Chou EL, Burch HB. 2022 Update on Clinical Management of Graves Disease and Thyroid Eye Disease. Endocrinol Metab Clin North Am. 2022 Jun;51(2):287-304. doi: 10.1016/j.ecl.2021.12.004. Epub 2022 May 11.
PubMed 35662442San Miguel I, Arenas M, Carmona R, Rutllan J, Medina-Rivero F, Lara P. Review of the treatment of Graves' ophthalmopathy: The role of the new radiation techniques. Saudi J Ophthalmol. 2018 Apr-Jun;32(2):139-145. doi: 10.1016/j.sjopt.2017.09.003. Epub 2017 Sep 21.
PubMed 29942184Bartalena L, Kahaly GJ, Baldeschi L, Dayan CM, Eckstein A, Marcocci C, Marino M, Vaidya B, Wiersinga WM; EUGOGO dagger. The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. Eur J Endocrinol. 2021 Aug 27;185(4):G43-G67. doi: 10.1530/EJE-21-0479.
PubMed 34297684Marcocci C, Bartalena L, Bogazzi F, Bruno-Bossio G, Lepri A, Pinchera A. Orbital radiotherapy combined with high dose systemic glucocorticoids for Graves' ophthalmopathy is more effective than radiotherapy alone: results of a prospective randomized study. J Endocrinol Invest. 1991 Nov;14(10):853-60. doi: 10.1007/BF03347943.
PubMed 1802923Torres Royo L, Antelo Redondo G, Arquez Pianetta M, Arenas Prat M. Low-Dose radiation therapy for benign pathologies. Rep Pract Oncol Radiother. 2020 Mar-Apr;25(2):250-254. doi: 10.1016/j.rpor.2020.02.004. Epub 2020 Feb 22.
PubMed 32140081Abdus-Salam AA, Olabumuyi AA, Jimoh MA, Folorunso SA, Orekoya AA. The role of radiation treatment in the management of inflammatory musculoskeletal conditions: a revisit. Radiat Oncol J. 2020 Sep;38(3):151-161. doi: 10.3857/roj.2020.00178. Epub 2020 Jun 18.
PubMed 33012142Weissmann T, Lettmaier S, Donaubauer AJ, Bert C, Schmidt M, Kruse F, Ott O, Hecht M, Fietkau R, Frey B, Putz F. Low- vs. high-dose radiotherapy in Graves' ophthalmopathy: a retrospective comparison of long-term results. Strahlenther Onkol. 2021 Oct;197(10):885-894. doi: 10.1007/s00066-021-01770-9. Epub 2021 Apr 16.
PubMed 33860819Johnson KT, Wittig A, Loesch C, Esser J, Sauerwein W, Eckstein AK. A retrospective study on the efficacy of total absorbed orbital doses of 12, 16 and 20 Gy combined with systemic steroid treatment in patients with Graves' orbitopathy. Graefes Arch Clin Exp Ophthalmol. 2010 Jan;248(1):103-9. doi: 10.1007/s00417-009-1214-3. Epub 2009 Oct 29.
PubMed 19865824Kahaly GJ, Rosler HP, Pitz S, Hommel G. Low- versus high-dose radiotherapy for Graves' ophthalmopathy: a randomized, single blind trial. J Clin Endocrinol Metab. 2000 Jan;85(1):102-8. doi: 10.1210/jcem.85.1.6257.
PubMed 10634372Kim M, Chang JH, Lee NK. Quantitative analysis of extraocular muscle volume and exophthalmos reduction after radiation therapy to treat Graves' ophthalmopathy: A pilot study. Eur J Ophthalmol. 2021 Mar;31(2):340-345. doi: 10.1177/1120672119873841. Epub 2019 Sep 9.
PubMed 31496266Lumyongsatien M, Keeratidamkerngsakul B, Pornpanich K, Vangveeravong S, Saonanon P, Wiwatwongwana D, Mahaisavariya P, Aryasit O, Pongpirul K. Development and psychometric properties of the Thai Graves' ophthalmopathy quality of life (GO-QOL) questionnaire. J Patient Rep Outcomes. 2019 Dec 31;4(1):1. doi: 10.1186/s41687-019-0164-8.
PubMed 31893319
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orbital Radiotherapy in Grave's Ophthalmopathy 1 Week vs 2 Weeks: A Phase II Randomized Controlled Trial (OraGO-1 Trial)
- ClinicalTrials.gov ID
- NCT06392906
- Acronym / sponsor ID
- SI208/2024
- Conditions
- Thyroid Associated Ophthalmopathy
- Keywords
- radiation therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Janjira PetsuksiriUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 1 May 2024 (actual)
- 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 ophthalmopathy, also known as thyroid eye disease or Graves' ophthalmopathy, is a condition characterized by inflammation and swelling of the tissues around the eyes, often accompanied by protrusion of the eyeballs. This condition can lead to significant discomfort, visual disturbances, and in severe cases, permanent vision loss.
Primary treatment modalities are intravenous methylprednisolone (IVMP) and other medications for patients with moderate to severe and active thyroid eye disease. In addition, external beam radiation therapy (ERT) is an another treatment option in combination with IVMP.
Radiation therapy delivers targeted doses of ionizing radiation to the affected orbital tissues, effectively reducing inflammation. This approach is particularly beneficial for patients who may not respond adequately to steroid therapy alone or those who experience recurrent disease flares.
This study will test the efficacy of a shortened treatment regimen comprising 5 sessions of ERT to a standard protocol of 10 treatments. The primary aim is to ascertain the effectiveness of shorted radiation treatment while improving patients' quality of life.
Detailed description
The research methodology of this study involves comparing the standard protocol of 10 radiation treatments with a modified approach comprising 5 treatments of daily External Beam Radiation Therapy (ERT).
The primary objective of this investigation is to assess whether reducing the number of radiation treatments while maintaining the effectiveness of the therapy can lead to improvements in the quality of life for patients with thyroid ophthalmopathy.
By comparing these two treatment regimens, researchers aim to evaluate the efficacy and safety of the abbreviated radiation schedule in managing the symptoms and progression of the disease.
Participants enrolled in the study will be randomized into two groups: one receiving the standard 10 treatments and the other receiving the modified 5-treatment regimen of daily ERT. Throughout the study period, participants will undergo comprehensive assessments to monitor changes in symptoms, vision, and quality of life. These evaluations will include ophthalmic examinations, imaging studies, and patient-reported outcome measures to capture both objective and subjective measures of treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 2 randomized control trial comparing between standard radiation therapy arm (20 Gy in 10 fractions) and experimental radiation therapy arm (10 Gy in 5 fractions)
| Arm | Type | Receives |
|---|---|---|
| 1 week external beam radiation therapy | Experimental | Radiation: Short course radiation therapy10 Gy in 5 fractions of external beam radiation therapy |
| 2 week external beam radiation therapy | Active comparator | Radiation: Standard course radiation therapy20 Gy in 10 fractions of standard fraction external beam radiation therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with active moderate to severe thyroid eye disease with a CAS > 4 with/ without diplopia before starting IVMP
- Patient with poor response to 3 doses of IVMP (CAS drop < 1) หรือ CAS score > 3 after 3 doses of IVMP
- Patients with diplopia after 3 doses of IVMP
- Patients with Graves' Ophthalmopathy who have maintained euthyroidism
- Non-pregnant adults (aged 35 years or older)
Key exclusion criteria (1 listed)
- Individuals with severe hypertension or diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short course radiation therapyAlso: 10 Gy in 5 fractions of radiation therapy5 daily radiation treatments | Radiation | 1 week external beam radiation therapy |
| Standard course radiation therapyAlso: 20 Gy in 10 fractions of radiation therapy10 daily radiation treatments | Radiation | 2 week external beam radiation therapy |
Primary outcome
Clinical Activity Score (CAS) change
Time frame: 6 months after initiation of IVMP
To evaluate the non-inferiority of outcomes in terms of the patient's proportion of converting from active (CAS > 4) to inactive eye disease (CAS <3) with CAS drop > 2 points, following orbital radiotherapy in combination with IVMP, comparing standard and reduced-dose orbital radiotherapy CAS score range from 1-7, initially and range from 1-10 at 1-3 months follow-up period. Higher CAS scores represented worse outcomes.
6 secondary outcomes
muscle and retrobulbar fat volume change
Time frame: 6 months after initiation of IVMP
change in diplopia
Time frame: 6 months after initiation of IVMP
change in quality of life
Time frame: 6 months after initiation of IVMP
Radiation toxicities
Time frame: 6 months after initiation of IVMP
Visual acuity (VA)
Time frame: 6 months after initiation of IVMP
Visual field (VF)
Time frame: 6 months after initiation of IVMP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Results publication: PubMed 35662442Hoang TD, Stocker DJ, Chou EL, Burch HB. 2022 Update on Clinical Management of Graves Disease and Thyroid Eye Disease. Endocrinol Metab Clin North Am. 2022 Jun;51(2):287-304. doi: 10.1016/j.ecl.2021.12.004. Epub 2022 May 11.
- Results publication: PubMed 29942184San Miguel I, Arenas M, Carmona R, Rutllan J, Medina-Rivero F, Lara P. Review of the treatment of Graves' ophthalmopathy: The role of the new radiation techniques. Saudi J Ophthalmol. 2018 Apr-Jun;32(2):139-145. doi: 10.1016/j.sjopt.2017.09.003. Epub 2017 Sep 21.
- Results publication: PubMed 34297684Bartalena L, Kahaly GJ, Baldeschi L, Dayan CM, Eckstein A, Marcocci C, Marino M, Vaidya B, Wiersinga WM; EUGOGO dagger. The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy. Eur J Endocrinol. 2021 Aug 27;185(4):G43-G67. doi: 10.1530/EJE-21-0479.
- Results publication: PubMed 1802923Marcocci C, Bartalena L, Bogazzi F, Bruno-Bossio G, Lepri A, Pinchera A. Orbital radiotherapy combined with high dose systemic glucocorticoids for Graves' ophthalmopathy is more effective than radiotherapy alone: results of a prospective randomized study. J Endocrinol Invest. 1991 Nov;14(10):853-60. doi: 10.1007/BF03347943.
- Results publication: PubMed 32140081Torres Royo L, Antelo Redondo G, Arquez Pianetta M, Arenas Prat M. Low-Dose radiation therapy for benign pathologies. Rep Pract Oncol Radiother. 2020 Mar-Apr;25(2):250-254. doi: 10.1016/j.rpor.2020.02.004. Epub 2020 Feb 22.
- Results publication: PubMed 33012142Abdus-Salam AA, Olabumuyi AA, Jimoh MA, Folorunso SA, Orekoya AA. The role of radiation treatment in the management of inflammatory musculoskeletal conditions: a revisit. Radiat Oncol J. 2020 Sep;38(3):151-161. doi: 10.3857/roj.2020.00178. Epub 2020 Jun 18.
- Results publication: PubMed 33860819Weissmann T, Lettmaier S, Donaubauer AJ, Bert C, Schmidt M, Kruse F, Ott O, Hecht M, Fietkau R, Frey B, Putz F. Low- vs. high-dose radiotherapy in Graves' ophthalmopathy: a retrospective comparison of long-term results. Strahlenther Onkol. 2021 Oct;197(10):885-894. doi: 10.1007/s00066-021-01770-9. Epub 2021 Apr 16.
- Results publication: PubMed 19865824Johnson KT, Wittig A, Loesch C, Esser J, Sauerwein W, Eckstein AK. A retrospective study on the efficacy of total absorbed orbital doses of 12, 16 and 20 Gy combined with systemic steroid treatment in patients with Graves' orbitopathy. Graefes Arch Clin Exp Ophthalmol. 2010 Jan;248(1):103-9. doi: 10.1007/s00417-009-1214-3. Epub 2009 Oct 29.
- Results publication: PubMed 10634372Kahaly GJ, Rosler HP, Pitz S, Hommel G. Low- versus high-dose radiotherapy for Graves' ophthalmopathy: a randomized, single blind trial. J Clin Endocrinol Metab. 2000 Jan;85(1):102-8. doi: 10.1210/jcem.85.1.6257.
- Results publication: PubMed 31496266Kim M, Chang JH, Lee NK. Quantitative analysis of extraocular muscle volume and exophthalmos reduction after radiation therapy to treat Graves' ophthalmopathy: A pilot study. Eur J Ophthalmol. 2021 Mar;31(2):340-345. doi: 10.1177/1120672119873841. Epub 2019 Sep 9.
- Results publication: PubMed 31893319Lumyongsatien M, Keeratidamkerngsakul B, Pornpanich K, Vangveeravong S, Saonanon P, Wiwatwongwana D, Mahaisavariya P, Aryasit O, Pongpirul K. Development and psychometric properties of the Thai Graves' ophthalmopathy quality of life (GO-QOL) questionnaire. J Patient Rep Outcomes. 2019 Dec 31;4(1):1. doi: 10.1186/s41687-019-0164-8.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) may include sensitive information about participants, such as medical history or demographic details, particularly regarding their quality of life. Sharing IPD will be conducted in accordance with Siriraj Institutional Review Board (IRB) regulations for personal data protection."
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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.
Janjira Petsuksiri, M.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Short course radiation therapy and Standard course radiation therapy in people with Thyroid Associated Ophthalmopathy, run by Janjira Petsuksiri at 1 site in Thailand.
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 1 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janjira Petsuksiri, M.D. (66919966662, janjira.pet@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Activity Score (CAS) change (time frame: 6 months after initiation of IVMP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06392906, which also lists 11 linked publications.
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 4 Dec 2024.