A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Behcet's Syndrome
Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Female Patients With Behcet's Syndrome
Intervention: Abatacept (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: New York University School of Medicine Overall contact: Margaret Andrew, RN, BSN, Phone: 646-501-7380, Email: margaret.andrew@nyumc.org
Summary
Hypothesis: Abatacept injections will decrease the number of oral ulcers seen in Behcet's
patients
Clinical Details
Official title: A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Mucocutaneous Manifestations of Behcet's Syndrome
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: ulcers
Secondary outcome: Genital ulcersTreatment failures Oral ulcer pain Side Effects MDHAQ BSAS BDCAF
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria
1. 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.
2. Female patients with a diagnosis of Behcet's syndrome
3. Women, greater than 18 years of age
4. 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.
5. Patients must have oral ulcers or genital ulcers that have been resistant to
colchicine or topical measures for at least a month.
Exclusion Criteria:
1. 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.
2. Women who are pregnant or breastfeeding.
3. 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)
4. Subjects who are impaired, incapacitated, or incapable of completing study-related
assessments.
5. 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.
6. 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.
7. 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.
8. Subjects who currently abuse drugs or alcohol.
9. 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.
10. Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months
before the informed consent document was signed.
11. Subjects who have received any live vaccines within 3 months of the anticipated first
dose of study medication.
12. 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).
13. Subjects at risk for tuberculosis (TB).
14. Subjects must not be positive for hepatitis B surface antigen.
15. 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.
16. Subjects with any of the following laboratory values
17. Hemoglobin < 8. 5 g/dL
18. WBC < 3000/mm3 (< 3 x 109/L)
19. Platelets < 100,000/mm3 (< 3 x 109/L)
20. Serum creatinine > 2 times the ULN
21. Serum ALT or AST > 2 times the ULN
22. Any other laboratory test results that, in the opinion of the investigator, might
place a subject at unacceptable risk for participation in the study.
23. 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.
24. Any concomitant biologic DMARD.
Locations and Contacts
Margaret Andrew, RN, BSN, Phone: 646-501-7380, Email: margaret.andrew@nyumc.org
NYU Center for Musculoskeletal Care, New York, New York 10016, United States; Recruiting Margaret Andrew, RN, BSN, Phone: 646-501-7380, Email: margaret.andrew@nyumc.org Yusuf Yazici, MD, Principal Investigator
Additional Information
NYU Center for Musculoskeletal Care
Starting date: June 2012
Last updated: July 31, 2015
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