Behcet's SyndromePhase 2NCT00001865
HAT in Eye Complications of Behcet's Disease
A Phase 2 study testing Daclizumab in people with Behcet's Syndrome and Retinal Disease, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This study will evaluate the safety and effectiveness of Zenapax in controlling recurrent eye inflammations associated with Behcet's disease. Behcet's disease is usually treated with corticosteroids to suppress inflammation. Other medicines such as methotrexate, cyclophosphamide, or azathioprine may also be used. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Behcet's Syndrome, Retinal Disease, Uveitis
- What is being tested?
- Daclizumab
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1999to Jun 2004
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must be 18 years of age or older for the primary randomized cohort.
- Up to six additional patients under 18 but more than 6 years of age may enroll in a separate stratum.
- Patients has ocular complications of Behcet's disease.
- Patients is currently taking a minimum of 15 mg of prednisone, or cyclosporine, or anti-metabolites, or any combination of these for the treatment of their intraocular inflammatory disease and retinal vasculitis for at least the past 3 months.
- Patients must have had at least two documented ocular attacks due to their Behcet's disease involving the posterior segment.
- Patients has normal renal or liver function or evidence of only mild abnormalities as defined by the WHO criteria.
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- Patients has a neutrophil count above 750.
- Patients agrees to use acceptable birth control methods throughout the course of the study and for 6 months after completion of treatment if assigned to Zenapax. If patient is assigned to placebo and has been unmasked, the patient need not practice birth control.
- Patients is able to understand and sign a consent form before entering into the study. Minor patients will be required to sign an assent.
Who cannot join
- Patients has received previous treatment with an IL-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety, efficacy, or pharmacokinetics of Zenapax.
- Patients has significant active infection.
- Patients has a history of cancer (other than non-melanoma skin cancer) within the past 5 years.
- Patient is pregnant or lactating.
- Patients with significant symptomatic neurological disease which complicates evaluation of neurological sequelae of Behcet's disease. This would include multiple sclerosis, stroke, and other neurodegenerative disease are not eligible. Neuro-Behcet's disease would be permitted.
- In the opinion of the treating physicians the ocular disease is end-stage, and there would be no reasonable hope for an improvement in visual acuity.
- Patient has used Latanoprost within two weeks prior to enrollment, or has a current or likely need for Latanaprost during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Eye Institute (NEI)
Bethesda, Maryland, 20892
About this study
Official title: A Study to Investigate the Safety and Efficacy of HAT to Treat the Ocular Complications Related to Behcet's Disease
This study will evaluate the safety and effectiveness of Zenapax in controlling recurrent eye inflammations associated with Behcet's disease.
Behcet's disease is usually treated with corticosteroids to suppress inflammation. Other medicines such as methotrexate, cyclophosphamide, or azathioprine may also be used. These drugs all can have serious side effects, including liver or kidney damage. Zenapax is a monoclonal antibody that binds to certain proteins (receptors) on white blood cells, preventing them from interacting with a chemical called interleukin-2. Blocking this interaction prevents inflammation.
Read more
This study will include 20 patients who had unacceptable side effects from other medicines used to treat their disease; did not benefit from standard treatment; and refused standard treatment because of possible side effects of the medicines.
All patients in the study will continue to take their current medicines at the start of the study. In addition, one group of patients will receive Zenapax and a second group will receive a placebo. The drug or placebo will be infused into the vein at the start of the study and every two weeks for the next six weeks, and then every four weeks for the rest of the study period (24 months). Each infusion lasts about 15 minutes. Patients will have eye examinations at the time of every treatment, and medicines will be added if needed to control eye disease. Drugs will be tapered after six months in patients whose eye disease is quiet, and readjusted as necessary. Neither the doctors nor the patients will know who is receiving placebo and who is receiving Zenapax until the study ends.
Patients will be given a physical examination, medical history, eye examination, fluorescein angiography (special photographs of the retina to evaluate the blood vessels in the eye), and blood tests.
Zenapax was previously studied in 10 patients with uveitis with positive results. The patients were able to reduce the other medicines they were taking with minimal side effects.
Read the detailed description
The development of an ideal therapy to immunosuppress patients with Behcet's disease, a cause of endogenous uveitis and a major cause of acquired blindness in adults, is an important research goal. Corticosteroids remain the mainstay of therapy for intraocular inflammation; however, many patients are intolerant or resistant to corticosteroid therapy. Although the etiology of Behcet's disease is unknown, evidence suggests that an interleukin-2 receptor bearing auto-aggressive cells may play an important role in this disorder. Zenapax, a humanized anti-TAC (T-cell activated antigen) monoclonal antibody (HAT), has been utilized in Protocol # 96-EI-0096, a pilot Phase I/II study, to evaluate Zenapax administration in the treatment of patients with endogenous sight-threatening uveitis. Long-term results demonstrate a positive therapeutic trend in this trial. We propose a randomized masked pilot trial of Zenapax versus placebo. Twenty patients who are 18 years of age or older with Behcet's disease will be randomly assigned to receive either Zenapax or placebo in addition to their standard immunosuppressive therapy. After six months of quiescent disease, patients will be eligible to taper their standard immunosuppressive therapy. The primary purpose of the study is to investigate the safety and efficacy of Zenapax in controlling the recurrent, explosive nature of ocular manifestations in patients with Behcet's disease. Because this study is a Phase I/II study examining both efficacy and safety, primary outcomes for each are defined. The primary safety endpoint is one of the following: a) development of a life threatening complication, namely an exacerbation of systemic or neurological disease, or b) the development of a severe opportunistic infection. The primary efficacy outcomes of this study are based on the number of ocular attacks experienced and the amount of immunosuppressive medications over the 2 year study period, including the ability to taper the standard immunosuppressive therapy. Secondary efficacy outcomes include the level of inflammation as measured by vitreous haze and anterior chamber cells and flare, the presence or absence of cystoid macular edema, the change from baseline in visual acuity, and quality of life issues as measured through questionnaires.
- Conditions
- Behcet's Syndrome, Retinal Disease, Uveitis
- Being tested
- Daclizumab
- Keywords
- Behcet's, Monoclonal Antibody, Uveitis, Interleukin 2, Retinal Vasculitis, Hyopyon, Interleukin 2 Receptor, Bechet's Disease, Ocular Disease
- Medical subject headings
- Behcet Syndrome, Retinal Diseases, Uveitis, Retinal Vasculitis, Diabetes Mellitus, Insulin-Dependent, 10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaclizumabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJul 1999
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Enrolment
- 26 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001865
- Sponsor's protocol ID
- 990135
- Other IDs
- 99-EI-0135
- Status last verified
- Jun 2004
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Reed MH, Shapiro ME, Strom TB, Milford EL, Carpenter CB, Weinberg DS, Reimann KA, Letvin NL, Waldmann TA, Kirkman RL. Prolongation of primate renal allograft survival by anti-Tac, an anti-human IL-2 receptor monoclonal antibody. Transplantation. 1989 Jan;47(1):55-9. doi: 10.1097/00007890-198901000-00013.
PubMed 2643232Brown PS Jr, Parenteau GL, Dirbas FM, Garsia RJ, Goldman CK, Bukowski MA, Junghans RP, Queen C, Hakimi J, Benjamin WR, et al. Anti-Tac-H, a humanized antibody to the interleukin 2 receptor, prolongs primate cardiac allograft survival. Proc Natl Acad Sci U S A. 1991 Apr 1;88(7):2663-7. doi: 10.1073/pnas.88.7.2663.
PubMed 2011577Herve P, Wijdenes J, Bergerat JP, Bordigoni P, Milpied N, Cahn JY, Clement C, Beliard R, Morel-Fourrier B, Racadot E, et al. Treatment of corticosteroid resistant acute graft-versus-host disease by in vivo administration of anti-interleukin-2 receptor monoclonal antibody (B-B10). Blood. 1990 Feb 15;75(4):1017-23.
PubMed 2136244
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Safety and Efficacy of HAT to Treat the Ocular Complications Related to Behcet's Disease
- ClinicalTrials.gov ID
- NCT00001865
- Acronym / sponsor ID
- 990135
- Conditions
- Behcet's Syndrome, Retinal Disease, Uveitis
- Keywords
- Behcet's, Monoclonal Antibody, Uveitis, Interleukin 2, Retinal Vasculitis, Hyopyon, Interleukin 2 Receptor, Bechet's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Jul 1999
- Study completion
- Jun 2004
- First posted
- 4 Nov 1999 (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 will evaluate the safety and effectiveness of Zenapax in controlling recurrent eye inflammations associated with Behcet's disease.
Behcet's disease is usually treated with corticosteroids to suppress inflammation. Other medicines such as methotrexate, cyclophosphamide, or azathioprine may also be used. These drugs all can have serious side effects, including liver or kidney damage. Zenapax is a monoclonal antibody that binds to certain proteins (receptors) on white blood cells, preventing them from interacting with a chemical called interleukin-2. Blocking this interaction prevents inflammation.
This study will include 20 patients who had unacceptable side effects from other medicines used to treat their disease; did not benefit from standard treatment; and refused standard treatment because of possible side effects of the medicines.
All patients in the study will continue to take their current medicines at the start of the study. In addition, one group of patients will receive Zenapax and a second group will receive a placebo. The drug or placebo will be infused into the vein at the start of the study and every two weeks for the next six weeks, and then every four weeks for the rest of the study period (24 months). Each infusion lasts about 15 minutes. Patients will have eye examinations at the time of every treatment, and medicines will be added if needed to control eye disease. Drugs will be tapered after six months in patients whose eye disease is quiet, and readjusted as necessary. Neither the doctors nor the patients will know who is receiving placebo and who is receiving Zenapax until the study ends.
Patients will be given a physical examination, medical history, eye examination, fluorescein angiography (special photographs of the retina to evaluate the blood vessels in the eye), and blood tests.
Zenapax was previously studied in 10 patients with uveitis with positive results. The patients were able to reduce the other medicines they were taking with minimal side effects.
Detailed description
The development of an ideal therapy to immunosuppress patients with Behcet's disease, a cause of endogenous uveitis and a major cause of acquired blindness in adults, is an important research goal. Corticosteroids remain the mainstay of therapy for intraocular inflammation; however, many patients are intolerant or resistant to corticosteroid therapy. Although the etiology of Behcet's disease is unknown, evidence suggests that an interleukin-2 receptor bearing auto-aggressive cells may play an important role in this disorder. Zenapax, a humanized anti-TAC (T-cell activated antigen) monoclonal antibody (HAT), has been utilized in Protocol # 96-EI-0096, a pilot Phase I/II study, to evaluate Zenapax administration in the treatment of patients with endogenous sight-threatening uveitis. Long-term results demonstrate a positive therapeutic trend in this trial. We propose a randomized masked pilot trial of Zenapax versus placebo. Twenty patients who are 18 years of age or older with Behcet's disease will be randomly assigned to receive either Zenapax or placebo in addition to their standard immunosuppressive therapy. After six months of quiescent disease, patients will be eligible to taper their standard immunosuppressive therapy. The primary purpose of the study is to investigate the safety and efficacy of Zenapax in controlling the recurrent, explosive nature of ocular manifestations in patients with Behcet's disease. Because this study is a Phase I/II study examining both efficacy and safety, primary outcomes for each are defined. The primary safety endpoint is one of the following: a) development of a life threatening complication, namely an exacerbation of systemic or neurological disease, or b) the development of a severe opportunistic infection. The primary efficacy outcomes of this study are based on the number of ocular attacks experienced and the amount of immunosuppressive medications over the 2 year study period, including the ability to taper the standard immunosuppressive therapy. Secondary efficacy outcomes include the level of inflammation as measured by vitreous haze and anterior chamber cells and flare, the presence or absence of cystoid macular edema, the change from baseline in visual acuity, and quality of life issues as measured through questionnaires.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be 18 years of age or older for the primary randomized cohort.
- Up to six additional patients under 18 but more than 6 years of age may enroll in a separate stratum.
- Patients has ocular complications of Behcet's disease.
- Patients is currently taking a minimum of 15 mg of prednisone, or cyclosporine, or anti-metabolites, or any combination of these for the treatment of their intraocular inflammatory disease and retinal vasculitis for at least the past 3 months.
- Patients must have had at least two documented ocular attacks due to their Behcet's disease involving the posterior segment.
Key exclusion criteria (7 listed)
- Patients has received previous treatment with an IL-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety, efficacy, or pharmacokinetics of Zenapax.
- Patients has significant active infection.
- Patients has a history of cancer (other than non-melanoma skin cancer) within the past 5 years.
- Patient is pregnant or lactating.
- Patients with significant symptomatic neurological disease which complicates evaluation of neurological sequelae of Behcet's disease. This would include multiple sclerosis, stroke, and other neurodegenerative disease are not eligible. Neuro-Behcet's disease would be permitted.
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 |
|---|---|---|
| Daclizumab | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 2643232Reed MH, Shapiro ME, Strom TB, Milford EL, Carpenter CB, Weinberg DS, Reimann KA, Letvin NL, Waldmann TA, Kirkman RL. Prolongation of primate renal allograft survival by anti-Tac, an anti-human IL-2 receptor monoclonal antibody. Transplantation. 1989 Jan;47(1):55-9. doi: 10.1097/00007890-198901000-00013.
- Background: PubMed 2011577Brown PS Jr, Parenteau GL, Dirbas FM, Garsia RJ, Goldman CK, Bukowski MA, Junghans RP, Queen C, Hakimi J, Benjamin WR, et al. Anti-Tac-H, a humanized antibody to the interleukin 2 receptor, prolongs primate cardiac allograft survival. Proc Natl Acad Sci U S A. 1991 Apr 1;88(7):2663-7. doi: 10.1073/pnas.88.7.2663.
- Background: PubMed 2136244Herve P, Wijdenes J, Bergerat JP, Bordigoni P, Milpied N, Cahn JY, Clement C, Beliard R, Morel-Fourrier B, Racadot E, et al. Treatment of corticosteroid resistant acute graft-versus-host disease by in vivo administration of anti-interleukin-2 receptor monoclonal antibody (B-B10). Blood. 1990 Feb 15;75(4):1017-23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Daclizumab in people with Behcet's Syndrome and Retinal Disease, run by National Eye Institute (NEI) at 1 site in United States.
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 9 inclusion and 7 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 4 Mar 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001865, which also lists 3 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 Mar 2008.