Behcet's SyndromePhase 2NCT00664599
Rituximab for the Treatment of Severe Ocular Manifestations of Behcet's Disease
A Phase 2 study testing Rituximab and Cytotoxic Combination in people with Behcet's Syndrome, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to find if Rituximab can improve severe ocular lesions of Behcet's Disease. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Behcet's Syndrome
- What is being tested?
- Rituximab and Cytotoxic Combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Apr 2006to Jan 2008
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Behcet's Disease fulfilling the new International Criteria for Behcet's Disease
- Having active ocular lesions (posterior and/or retinal vasculitis)
- Resistant to cytotoxic drugs + prednisolone 0.5 mg/kg
Who cannot join
- Visual acuity less than 1/10 on Snellen chart
- Antecedent of allergic reaction to any component of the therapeutic regimen
Trial locations and contacts
1 site in 1 country.
Iran1 site
Rheumatology Research Center, Shariati Hospital
Tehran, Tehran Province, 14114
About this study
Official title: Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study)
The purpose of this study is to find if Rituximab can improve severe ocular lesions of Behcet's Disease.
Read the detailed description
To test in a single blind randomized control study the efficacy of Rituximab versus combination of pulse cyclophosphamide and azathioprine. Both group receiving 0.5 mg/kg/daily prednisolone.
- Conditions
- Behcet's Syndrome
- Being tested
- Rituximab, Cytotoxic Combination
- Keywords
- Ocular lesions, Visual Acuity, Retinal Vasculitis
- Medical subject headings
- Behcet Syndrome, Retinal Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Mabthera, Rituxan
Infusion of Rituximab, 1500 mg, two times with 15 days interval. Patients receive also Methotrexate (15 mg weekly) and Prednisolone (0.5 mg/daily).
Cytotoxic CombinationDrug
Also called Cytoxan
Pulse cyclophosphamide 1000 mg in perfusion, once monthly monthly. Azathioprine 3 mg/kg/body weight daily + prednisolone 0.5 mg/kg/daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rituximab Receives: Drug: Rituximab |
| 2 | Active comparator | Cytotoxics combination Receives: Drug: Cytotoxic Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 6 months
Secondary outcomes (3)
Inflammatory index for posterior uveitis
Measured: 6 months
Inflammatory index for retinal vasculitis, especially for edema
Measured: 6 months
Total Adjusted Disease Activity Index (TADAI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startApr 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet's 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Fereydoun Davatchi, MD, Study chair, Rheumatology Research Center, Tehran University for Medical SciencesHormoz Shams, MD, Principal investigator, Rheumatology Research Center, Tehran University for Medical SciencesMozhgan Rezaipoor, MD, Principal investigator, Rheumatology Research Center, Tehran University for Medical SciencesFarhad Shahram, MD, Principal investigator, Rheumatology Research Center, Tehran University for Medical SciencesCheyda Chams-Davatchi, MD, Principal investigator, Rheumatology Research Center, Tehran University for Medical SciencesBahar Sadeghi, MD, Principal investigator, Rheumatology Research Center, Tehran University for Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664599
- Sponsor's protocol ID
- 132/12487
- Status last verified
- Apr 2008
- First submitted
- 20 Apr 2008
- Last updated
- 30 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rituximab in the Treatment of Resistant Ocular Inflammatory Lesions of Behcet's Disease (Pilot Study)
- ClinicalTrials.gov ID
- NCT00664599
- Acronym / sponsor ID
- 132/12487
- Conditions
- Behcet's Syndrome
- Keywords
- Ocular lesions, Visual Acuity, Retinal Vasculitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Apr 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 23 Apr 2008 (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 Rituximab can improve severe ocular lesions of Behcet's Disease.
Detailed description
To test in a single blind randomized control study the efficacy of Rituximab versus combination of pulse cyclophosphamide and azathioprine. Both group receiving 0.5 mg/kg/daily prednisolone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RituximabRituximab |
| 2 | Active comparator | Drug: Cytotoxic CombinationCytotoxics combination |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Behcet's Disease fulfilling the new International Criteria for Behcet's Disease
- Having active ocular lesions (posterior and/or retinal vasculitis)
- Resistant to cytotoxic drugs + prednisolone 0.5 mg/kg
Key exclusion criteria (2 listed)
- Visual acuity less than 1/10 on Snellen chart
- Antecedent of allergic reaction to any component of the therapeutic regimen
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 |
|---|---|---|
| RituximabAlso: Mabthera, RituxanInfusion of Rituximab, 1500 mg, two times with 15 days interval. Patients receive also Methotrexate (15 mg weekly) and Prednisolone (0.5 mg/daily). | Drug | 1 |
| Cytotoxic CombinationAlso: CytoxanPulse cyclophosphamide 1000 mg in perfusion, once monthly monthly. Azathioprine 3 mg/kg/body weight daily + prednisolone 0.5 mg/kg/daily. | Drug | 2 |
Primary outcome
Visual acuity
Time frame: 6 months
3 secondary outcomes
Inflammatory index for posterior uveitis
Time frame: 6 months
Inflammatory index for retinal vasculitis, especially for edema
Time frame: 6 months
Total Adjusted Disease Activity Index (TADAI)
Time frame: 6 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 Apr 2008.
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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, Tehran University for Medical Sciences
Hormoz Shams, MD principal investigator
Rheumatology Research Center, Tehran University for Medical Sciences
Mozhgan Rezaipoor, MD principal investigator
Rheumatology Research Center, Tehran University for Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab and Cytotoxic Combination in people with Behcet's Syndrome, 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 2 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 Apr 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual acuity (time frame: 6 months). 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 Apr 2008.