Graves' OphthalmopathyPhase 4NCT01969019
A Prospective, Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy
A Phase 4 study testing methylprednisolone, prednisone in people with Graves' Ophthalmopathy, run by Ruijin Hospital at 1 site in China.
Trial summary
This study was designed to compare the efficacy and safety of 4.5g iv MP administered in 12 weeks and 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graves' Ophthalmopathy
- What is being tested?
- methylprednisolone, prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Oct 2013
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should meet the criteria of either a or b and together with c, d and e to include into the study.
- Lid retraction with any one of the following: i) Thyroid dysfunction ii) Proptosis iii) Optic nerve involvement iv) Extraocular muscle involvement b. Thyroid dysfunction with any one of the following: i) Proptosis ii) Optic nerve involvement iii) Extraocular muscle involvement c. Exclude cases with such ophthalmological signs caused by other diseases. d. Moderate to severe patients defined by EUGOGO. e. Clinical activity score (CAS)≥3/7 f. Normal function of heart, liver and kidney.
Who cannot join
- Orbital decompression surgery needed immediately
- History of chronic recurrent or active infection
- History of peptic ulcer
- Patients with a history of chronic liver disease or liver disorders； ALT or AST above 2.5 times upper limit of normal
- History of HIV, hepatitis C or hepatitis B Positive
- Cardiovascular or cerebrovascular disease clinically significant
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- Uncontrolled diabetes mellitus
- Use of corticosteroids during 12 weeks before to inclusion period
- Pregnant patient or patient who is planning to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Institute of Endocrine and Metabolic Diseases Department of Endocrine and Metabolic Diseases, Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Wei Zhu, Attending, (8621)64370045 ext. 602105, juvey1515@gmail.com
About this study
Official title: A Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy
This study was designed to compare the efficacy and safety of 4.5g iv MP administered in 12 weeks and 4 weeks.
- Conditions
- Graves' Ophthalmopathy
- Being tested
- methylprednisolone, prednisone
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylprednisolone, prednisoneDrug
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone | Active comparator | intravenous MP: 0.5g weekly for six weeks followed by 0.25g weekly for six weeks Receives: Drug: methylprednisolone, prednisone |
| methylprednisolone plus prednisone | Active comparator | intravenous MP 0.5g daily for three days per week, twice, followed by 0.25g daily for three days per week, twice, and followed by tapering oral prednisone (starting with 60mg/d, then10 mg less/week than each previous week for the next 3 weeks, then20mg/week at the 5th week followed with 5mg less/week than each previous week for the next 3 weeks) Receives: Drug: methylprednisolone, prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: 3 months
Secondary outcomes (1)
change of CAS, adverse effects and retreat
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startJan 2010
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graves' OphthalmopathyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhu, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969019
- Sponsor's protocol ID
- CCEMD015
- Status last verified
- Oct 2013
- First submitted
- 21 Oct 2013
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhu W, Ye L, Shen L, Jiao Q, Huang F, Han R, Zhang X, Wang S, Wang W, Ning G. A prospective, randomized trial of intravenous glucocorticoids therapy with different protocols for patients with graves' ophthalmopathy. J Clin Endocrinol Metab. 2014 Jun;99(6):1999-2007. doi: 10.1210/jc.2013-3919. Epub 2014 Feb 28.
PubMed 24606088
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy
- ClinicalTrials.gov ID
- NCT01969019
- Acronym / sponsor ID
- CCEMD015
- Conditions
- Graves' Ophthalmopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 24 Oct 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.
This study was designed to compare the efficacy and safety of 4.5g iv MP administered in 12 weeks and 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone | Active comparator | Drug: methylprednisolone, prednisoneintravenous MP: 0.5g weekly for six weeks followed by 0.25g weekly for six weeks |
| methylprednisolone plus prednisone | Active comparator | Drug: methylprednisolone, prednisoneintravenous MP 0.5g daily for three days per week, twice, followed by 0.25g daily for three days per week, twice, and followed by tapering oral prednisone (starting with 60mg/d, then10 mg less/week than each previous week for the next 3 weeks, then20mg/week at the 5th week followed with 5mg less/week than each previous week for the next 3 weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients should meet the criteria of either a or b and together with c, d and e to include into the study.
Key exclusion criteria (9 listed)
- Orbital decompression surgery needed immediately
- History of chronic recurrent or active infection
- History of peptic ulcer
- Patients with a history of chronic liver disease or liver disorders； ALT or AST above 2.5 times upper limit of normal
- History of HIV, hepatitis C or hepatitis B Positive
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 |
|---|---|---|
| methylprednisolone, prednisone | Drug | methylprednisolone, methylprednisolone plus prednisone |
Primary outcome
response rate
Time frame: 3 months
1 secondary outcome
change of CAS, adverse effects and retreat
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2013.
- Derived from this study: PubMed 24606088Zhu W, Ye L, Shen L, Jiao Q, Huang F, Han R, Zhang X, Wang S, Wang W, Ning G. A prospective, randomized trial of intravenous glucocorticoids therapy with different protocols for patients with graves' ophthalmopathy. J Clin Endocrinol Metab. 2014 Jun;99(6):1999-2007. doi: 10.1210/jc.2013-3919. Epub 2014 Feb 28.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methylprednisolone, prednisone in people with Graves' Ophthalmopathy, run by Ruijin Hospital at 1 site in China.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Oct 2013. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Guang, Professor ((8621)64370045 ext. 665344, guangning@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 3 months). 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 NCT01969019, which also lists 1 linked publication.
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 24 Oct 2013.