Behcet's DiseasePhase 4NCT01306955
The Efficacy of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease
A Phase 4 study testing methylorednisolone and dextrose water 5% in people with Behcet's Disease, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The goal of this study is to examine the efficacy of 1gram/day intravenous pulses of methylprednisolone on 3 consecutive days in Behcet's patients with ocular involvement. A total of 34 Behcet's patients referring to Behcet's clinic in Shariati hospital whose problem was confirmed with new international criteria of… Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Behcet's Disease
- What is being tested?
- methylorednisolone and dextrose water 5%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIran
- Study dates
- Feb 2010to Aug 2011
- 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 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed Behcet's disease according to international criteria
- New or relapse of retinal vasculitis who received any cytotoxic or glucocorticoid since 2 months ago
- New or relapse of severe posterior uveitis who are candidate for cyclophosphamide and azathioprine according to their physician
Who cannot join
- Not Signing the informed consent
- Visual acuity lower than 1/10 by Snellen chart
- Presence of infectious diseases such as TB
- Presence of diabetes mellitus, hypertension, heart disease, liver disease, renal disease, or edema
- Presence of other glucocorticoid consumption contraindications
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Rheumatology Research Center, Tehran University of Medical Science
Tehran, 1411713135
Shahram Farhad, Professor, 0098-21-8802-6956, Shahramf@tums.ac.ir
Mastaneh Mohammadi, MD, 0098-21-8802-6956, Mastanehmohammadi88@gmail.com
About this study
Official title: The Efficacy of Intravenous Pulses of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease, a Double Blind Pilot Study
The goal of this study is to examine the efficacy of 1gram/day intravenous pulses of methylprednisolone on 3 consecutive days in Behcet's patients with ocular involvement. A total of 34 Behcet's patients referring to Behcet's clinic in Shariati hospital whose problem was confirmed with new international criteria of Behcet's disease (ICBD) will be randomly assigned into one of the two equal groups of intervention or control. Behcet's patients are those with ocular involvement who were under the same cytotoxic treatment with cyclophosphamide and azathioprine. For the patients in the intervention group, intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% or 100cc D/w5% on 3 consecutive days will be added to treatment diet. Then treatment will begin with oral prednisolone, 0.5 mg/kg. After that, all the patients were followed up with no other therapeutic intervention by study group. The patients will be visited every 2 months by an ophthalmologist and study group for 6 months in 3 settings. To estimate the ocular inflammation of patients, we use visual acuity, retinal and ocular posterior chamber inflammation index.
- Conditions
- Behcet's Disease
- Being tested
- methylorednisolone, dextrose water 5%
- Keywords
- retinal vasculitis, posterior uveitis, methylprednisolone
- Medical subject headings
- Behcet Syndrome, Retinal Vasculitis, Uveitis, Posterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylorednisoloneDrug
intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% on 3 consecutive days at beginning of treatment
dextrose water 5%Other
intravenous infusion of 100cc D/w 5% on 3 consecutive days at beginning of treatment
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone | Active comparator | patients who received methylprednisolone Receives: Drug: methylorednisolone |
| dextrose water 5% | Placebo comparator | patients who received dextrose water 5% as placebo Receives: Other: dextrose water 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCULAR IBDDAM INDEX
Iranian Behcet's disease Dynamic Activity measurement
Measured: 14 months
VISUAL ACUITY
Check visual acuity with snellen chart by ophthalmologist
Measured: 14
Secondary outcomes (3)
Inflammation in retin
Check inflammation in retin by ophthalmologist
Measured: 14
Inflammation in posterior chamber
Check inflammation in posterior uvea by ophthalmologist
Measured: 14
inflammation in anterior chamber
check inflammation in anterior chamber by ophthalmologist
Measured: 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startFeb 2010
- Primary completionJul 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet's 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Farhad Shahram, Professor, Principal investigator, Rheumatology Research Center, Tehran University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306955
- Sponsor's protocol ID
- 11192
- Status last verified
- Mar 2011
- First submitted
- 1 Mar 2011
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intravenous Pulses of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease, a Double Blind Pilot Study
- ClinicalTrials.gov ID
- NCT01306955
- Acronym / sponsor ID
- 11192
- Conditions
- Behcet's Disease
- Keywords
- retinal vasculitis, posterior uveitis, methylprednisolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 2 Mar 2011 (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.
The goal of this study is to examine the efficacy of 1gram/day intravenous pulses of methylprednisolone on 3 consecutive days in Behcet's patients with ocular involvement. A total of 34 Behcet's patients referring to Behcet's clinic in Shariati hospital whose problem was confirmed with new international criteria of Behcet's disease (ICBD) will be randomly assigned into one of the two equal groups of intervention or control. Behcet's patients are those with ocular involvement who were under the same cytotoxic treatment with cyclophosphamide and azathioprine. For the patients in the intervention group, intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% or 100cc D/w5% on 3 consecutive days will be added to treatment diet. Then treatment will begin with oral prednisolone, 0.5 mg/kg. After that, all the patients were followed up with no other therapeutic intervention by study group. The patients will be visited every 2 months by an ophthalmologist and study group for 6 months in 3 settings. To estimate the ocular inflammation of patients, we use visual acuity, retinal and ocular posterior chamber inflammation index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone | Active comparator | Drug: methylorednisolonepatients who received methylprednisolone |
| dextrose water 5% | Placebo comparator | Other: dextrose water 5%patients who received dextrose water 5% as placebo |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed Behcet's disease according to international criteria
- New or relapse of retinal vasculitis who received any cytotoxic or glucocorticoid since 2 months ago
- New or relapse of severe posterior uveitis who are candidate for cyclophosphamide and azathioprine according to their physician
Key exclusion criteria (5 listed)
- Not Signing the informed consent
- Visual acuity lower than 1/10 by Snellen chart
- Presence of infectious diseases such as TB
- Presence of diabetes mellitus, hypertension, heart disease, liver disease, renal disease, or edema
- Presence of other glucocorticoid consumption contraindications
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 |
|---|---|---|
| methylorednisoloneintravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% on 3 consecutive days at beginning of treatment | Drug | methylprednisolone |
| dextrose water 5%intravenous infusion of 100cc D/w 5% on 3 consecutive days at beginning of treatment | Other | dextrose water 5% |
Primary outcome
OCULAR IBDDAM INDEX
Time frame: 14 months
Iranian Behcet's disease Dynamic Activity measurement
VISUAL ACUITY
Time frame: 14
Check visual acuity with snellen chart by ophthalmologist
3 secondary outcomes
Inflammation in retin
Time frame: 14
Inflammation in posterior chamber
Time frame: 14
inflammation in anterior chamber
Time frame: 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
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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.
Farhad Shahram, Professor principal investigator
Rheumatology Research Center, Tehran University of Medical Science
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 methylorednisolone and dextrose water 5% in people with Behcet's Disease, run by Tehran University of Medical Sciences at 1 site in Iran.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Mar 2011. 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 Iran. 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. Some participants in this study may receive a placebo. 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 Farhad Shahram, Professor (0098-21-8802-6956, Shahramf@tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCULAR IBDDAM INDEX (time frame: 14 months). The study lists 2 primary outcomes in all. 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 2 Mar 2011.