Female Patients With Behcet's SyndromeEarly Phase 1NCT01693640
A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Behcet's Syndrome
A Early Phase 1 study testing Abatacept in people with Female Patients With Behcet's Syndrome, run by NYU Langone Health at 1 site in United States.
Trial summary
Hypothesis: Abatacept injections will decrease the number of oral ulcers seen in Behcet's patients Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Patients With Behcet's Syndrome
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 28 Dec 2018
- Phase
- Early Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read. Then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel.
- Female patients with a diagnosis of Behcet's syndrome
- Women, greater than 18 years of age
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last dose of study drug to minimize the risk of pregnancy.
- Patients must have oral ulcers or genital ulcers that have been resistant to colchicine or topical measures for at least a month.
Who cannot join
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of study drug.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or before administration of abatacept.
- Target Disease Exceptions [Include as applicable]
- Any patients with systemic manifestations of Behcet's syndrome (Patients with eye, CNS, vascular involvement, gastrointestinal disease)
- Patients who are already on other immunosuppressive medications (azathioprine, TNF inhibitors, other biologic agents, methotrexate, mycophenolate mofetil, cyclosporine, cyclophosphamide)
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- Subjects who are impaired, incapacitated, or incapable of completing study-related assessments.
- Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, whether or not related to Behcet's syndrome and which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
- Female subjects who have had a breast cancer screening that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded by additional clinical, laboratory, or other diagnostic evaluations.
- Subjects with a history of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ.
- Subjects who currently abuse drugs or alcohol.
- Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of human immunodeficiency virus (HIV) detected during screening.
- Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months before the informed consent document was signed.
- Subjects who have received any live vaccines within 3 months of the anticipated first dose of study medication.
- Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection (eg, chronic pyelonephritis, osteomyelitis, or bronchiectasis).
- Subjects at risk for tuberculosis (TB).
- Subjects must not be positive for hepatitis B surface antigen.
- Subjects who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay.
- Subjects with any of the following laboratory values
- Hemoglobin < 8.5 g/dL
- WBC < 3000/mm3 (< 3 x 109/L)
- Platelets < 100,000/mm3 (< 3 x 109/L)
- Serum creatinine > 2 times the ULN
- Serum ALT or AST > 2 times the ULN
- Any other laboratory test results that, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
- Subjects who have at any time received treatment with any investigational drug within 28 days (or less than 5 terminal half-lives of elimination) of the Day 1 dose.
- Any concomitant biologic DMARD.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Center for Musculoskeletal Care
New York, New York, 10016
About this study
Official title: A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Mucocutaneous Manifestations of Behcet's Syndrome
Hypothesis: Abatacept injections will decrease the number of oral ulcers seen in Behcet's patients
Read the detailed description
This will be an open label study, where 20 Behcet's patients with resistant oral ulcers and 10 with resistant genital ulcers will be enrolled (screen 40). After enrollment all patients will be followed for a month to document the number of oral and genital ulcers on their current regimen. Then all patients will receive abatacept for 6 months (evaluated at weeks 0, 2, 4, 8, 12, 16 and 24). Then the treatment will be stopped and they will be observed for the next 2 months, for a total of 9 month trial.
- Conditions
- Female Patients With Behcet's Syndrome
- Being tested
- Abatacept
- Keywords
- Behcet's
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Also called Orencia
Weekly injections with Abatacept 125 mg over 6 months
| Study group | Role | What they receive |
|---|---|---|
| abatacept | Experimental | Not described Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
ulcers
The primary endpoint is number of oral and genital ulcers (AUC) during the treatment period
Measured: 6 month treatment period
Secondary outcomes (7)
Genital ulcers
Number of genital ulcers
Measured: 6 month treatment
Treatment failures
Number of patients who fail to complete 6 months (treatment failures)
Measured: 6 months
Oral ulcer pain
Oral ulcer pain-Visual Analog Scale (VAS)
Measured: 6 months
Side Effects
Monitoring of side effects
Measured: 6 months
MDHAQ
Multidimensional health assessment questionnaire (MDHAQ)
Measured: 6 months
BSAS
Behcet's syndrome activity score (BSAS)
Measured: 6 months
BDCAF
Behcet's disease current activity form (BDCAF) scores
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 posted26 Sep 2012 (estimated)
- Study startJun 2012
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Patients With Behcet's SyndromeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693640
- Sponsor's protocol ID
- 10-02611
- Status last verified
- Jan 2019
- First submitted
- 19 Sep 2012
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Mucocutaneous Manifestations of Behcet's Syndrome
- ClinicalTrials.gov ID
- NCT01693640
- Acronym / sponsor ID
- 10-02611
- Conditions
- Female Patients With Behcet's Syndrome
- Keywords
- Behcet's
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jun 2012 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 26 Sep 2012 (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.
Hypothesis: Abatacept injections will decrease the number of oral ulcers seen in Behcet's patients
Detailed description
This will be an open label study, where 20 Behcet's patients with resistant oral ulcers and 10 with resistant genital ulcers will be enrolled (screen 40). After enrollment all patients will be followed for a month to document the number of oral and genital ulcers on their current regimen. Then all patients will receive abatacept for 6 months (evaluated at weeks 0, 2, 4, 8, 12, 16 and 24). Then the treatment will be stopped and they will be observed for the next 2 months, for a total of 9 month trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| abatacept | Experimental | Drug: Abatacept |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Before any study procedures are performed, subjects will have the details of the study described to them, and they will be given a written informed consent document to read. Then, if subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel.
- Female patients with a diagnosis of Behcet's syndrome
- Women, greater than 18 years of age
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last dose of study drug to minimize the risk of pregnancy.
- Patients must have oral ulcers or genital ulcers that have been resistant to colchicine or topical measures for at least a month.
Key exclusion criteria (27 listed)
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of study drug.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or before administration of abatacept.
- Target Disease Exceptions [Include as applicable]
- Subjects who are impaired, incapacitated, or incapable of completing study-related assessments.
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 |
|---|---|---|
| AbataceptAlso: OrenciaWeekly injections with Abatacept 125 mg over 6 months | Drug | abatacept |
Primary outcome
ulcers
Time frame: 6 month treatment period
The primary endpoint is number of oral and genital ulcers (AUC) during the treatment period
7 secondary outcomes
Genital ulcers
Time frame: 6 month treatment
Treatment failures
Time frame: 6 months
Oral ulcer pain
Time frame: 6 months
Side Effects
Time frame: 6 months
MDHAQ
Time frame: 6 months
BSAS
Time frame: 6 months
BDCAF
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 28 Jan 2019.
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 Early Phase 1 study testing Abatacept in people with Female Patients With Behcet's Syndrome, run by NYU Langone Health 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 5 inclusion and 27 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 28 Jan 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
ulcers (time frame: 6 month treatment period). 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 28 Jan 2019.