Behcet SyndromeNCT00931957
Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
A study testing Etanercept, Methotrexate, Prednisolone in people with Behcet Syndrome and Uveal Disease, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to find if Etanercept can improve the outcome of ocular lesions of Behcet's Disease treated with Methotrexate and Prednisolone Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Behcet Syndrome, Uveal Disease
- What is being tested?
- Etanercept, Methotrexate, Prednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- Oct 2010to Oct 2013
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Behcet's Disease according to the International Criteria for Behcet's disease (ICBD)
- Active posterior uveitis and/or retinal vasculitis
Who cannot join
- Visual acuity inferior to 1/10 on Snellen chart
- Being under cytotoxic drugs or having received them in the past 2 months
- Not being able to follow the one year treatment and the regular follow ups
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Rheumatology Research Center, Behcet's Disease Unit (Shariati Hospital)
Tehran, 14114
Fereydoun Davatchi, MD, (98-21)8802-6956, fddh@davatchi.net
Bahar Sadeghi, MD, (98-21)8802-6956, bahar@bahars.net
About this study
The purpose of this study is to find if Etanercept can improve the outcome of ocular lesions of Behcet's Disease treated with Methotrexate and Prednisolone
Read the detailed description
To test in a randomized single blind control trial the efficacy of Etanercept in patients with posterior uveitis and/or retinal vasculitis of Behcet's disease treated with Methotrexate and prednisolone
- Conditions
- Behcet Syndrome, Uveal Disease
- Being tested
- Etanercept, Methotrexate, Prednisolone
- Keywords
- Etanercept, Behcet's syndrome, Behcet's Disease, Ocular Lesions, Uveitis, Retinal Vasculitis
- Medical subject headings
- Behcet Syndrome, Uveal Diseases, Uveitis, Retinal Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etanercept, Methotrexate, PrednisoloneDrug
Also called Enbrel
In: Arm A, Etanercept-MTX-Prednisolone:
Etanercept 50 mg weekly (subcutaneous injection) for 12 months. Methotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses.
In Arm B:
Methotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses.
| Study group | Role | What they receive |
|---|---|---|
| Etanercept-MTX-Prednisolone | Active comparator | Methotrexate + Prednisolone + Etanercept Receives: Drug: Etanercept, Methotrexate, Prednisolone |
| B, MTX-Prednisolone | Other | Methotrexate + Prednisolone Receives: Drug: Etanercept, Methotrexate, Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis
Measured: One Year
Secondary outcomes (1)
DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startOct 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Behcet SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- Fereydoun Davatchi, MD, Study chair, Rheumatology Research Center, Medical Sciences/University of Teheran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931957
- Sponsor's protocol ID
- 860241-5807
- Status last verified
- Nov 2010
- First submitted
- 30 Jun 2009
- Last updated
- 22 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Melikoglu M, Ozvazgan y Fresko I et al. The response of treatment resistant uveitis in Behcet's syndrome (BS) to a TNF-α blocker, Etanercept: an open study. Arthritis Rheum 2002; 46: S181, (Abstract) 400
Davatchi F, Shahram F, Chams H, Jamshidi AR, Nadji A, Chams C, Akbarian M, Gharibdoost F. High dose methotrexate for ocular lesions of Behcet's disease. Preliminary short-term results. Adv Exp Med Biol. 2003;528:579-84. doi: 10.1007/0-306-48382-3_118. No abstract available.
PubMed 12918769Davatchi F. New and innovative therapies for Behcet's Disease. APLAR Journal of Rheumatology 2004; 7: 141-145
Davatchi F, Shams H, Nadji A, Jamshidi AR, Akhlaghi M, Sadeghi Abdollahi B, Ziaie N, Akbarian M, Gharibdoost F. Management of ocular manifestations of Behcet's Disease: outcome with cytotoxic drugs. APLAR Journal of Rheumatology 2005; 8: 119-123
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease
- ClinicalTrials.gov ID
- NCT00931957
- Acronym / sponsor ID
- 860241-5807
- Conditions
- Behcet Syndrome, Uveal Disease
- Keywords
- Etanercept, Behcet's syndrome, Behcet's Disease, Ocular Lesions, Uveitis, Retinal Vasculitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 2 Jul 2009 (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 purpose of this study is to find if Etanercept can improve the outcome of ocular lesions of Behcet's Disease treated with Methotrexate and Prednisolone
Detailed description
To test in a randomized single blind control trial the efficacy of Etanercept in patients with posterior uveitis and/or retinal vasculitis of Behcet's disease treated with Methotrexate and prednisolone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etanercept-MTX-Prednisolone | Active comparator | Drug: Etanercept, Methotrexate, PrednisoloneMethotrexate + Prednisolone + Etanercept |
| B, MTX-Prednisolone | Other | Drug: Etanercept, Methotrexate, PrednisoloneMethotrexate + Prednisolone |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Behcet's Disease according to the International Criteria for Behcet's disease (ICBD)
- Active posterior uveitis and/or retinal vasculitis
Key exclusion criteria (3 listed)
- Visual acuity inferior to 1/10 on Snellen chart
- Being under cytotoxic drugs or having received them in the past 2 months
- Not being able to follow the one year treatment and the regular follow ups
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 |
|---|---|---|
| Etanercept, Methotrexate, PrednisoloneAlso: EnbrelIn: Arm A, Etanercept-MTX-Prednisolone: Etanercept 50 mg weekly (subcutaneous injection) for 12 months. Methotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses. In Arm B: Methotrexate 15 mg weekly for 12 months. Prednisolone: 30 mg daily, in divided doses, as initial dose. The dose will be reduced and adjusted to the eye's inflammation. Discontinuation if no inflammation with very low doses. | Drug | B, MTX-Prednisolone, Etanercept-MTX-Prednisolone |
Primary outcome
Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis
Time frame: One Year
1 secondary outcome
DAI for Anterior Uveitis, Total Inflammatory Acitivity Index, Total Adjusted Disease Activity Index
Time frame: One Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2010.
- BackgroundMelikoglu M, Ozvazgan y Fresko I et al. The response of treatment resistant uveitis in Behcet's syndrome (BS) to a TNF-α blocker, Etanercept: an open study. Arthritis Rheum 2002; 46: S181, (Abstract) 400
- Background: PubMed 12918769Davatchi F, Shahram F, Chams H, Jamshidi AR, Nadji A, Chams C, Akbarian M, Gharibdoost F. High dose methotrexate for ocular lesions of Behcet's disease. Preliminary short-term results. Adv Exp Med Biol. 2003;528:579-84. doi: 10.1007/0-306-48382-3_118. No abstract available.
- BackgroundDavatchi F. New and innovative therapies for Behcet's Disease. APLAR Journal of Rheumatology 2004; 7: 141-145
- BackgroundDavatchi F, Shams H, Nadji A, Jamshidi AR, Akhlaghi M, Sadeghi Abdollahi B, Ziaie N, Akbarian M, Gharibdoost F. Management of ocular manifestations of Behcet's Disease: outcome with cytotoxic drugs. APLAR Journal of Rheumatology 2005; 8: 119-123
- Rheumatology Research Center, Medical Sciences/University of TehranLink provided by the sponsor.
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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.
Fereydoun Davatchi, MD study chair
Rheumatology Research Center, Medical Sciences/University of Teheran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etanercept, Methotrexate, Prednisolone in people with Behcet Syndrome and Uveal 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 2 inclusion and 3 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 22 Nov 2010. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fereydoun Davatchi, MD ((98-21) 8802-6956, fddh@davatchi.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity, Disease Activity Index (DAI) for Posterior Uveitis, DAI for Retinal vasculitis (time frame: One Year). 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 NCT00931957, which also lists 4 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 22 Nov 2010.