A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Behcet's Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by New York University School of Medicine
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Yusuf Yazici, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01693640
First received: September 19, 2012
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

Hypothesis: Abatacept injections will decrease the number of oral ulcers seen in Behcet's patients


Condition Intervention
Female Patients With Behcet's Syndrome
Drug: Abatacept

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Mucocutaneous Manifestations of Behcet's Syndrome

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • ulcers [ Time Frame: 6 month treatment period ] [ Designated as safety issue: Yes ]
    The primary endpoint is number of oral and genital ulcers (AUC) during the treatment period


Secondary Outcome Measures:
  • Genital ulcers [ Time Frame: 6 month treatment ] [ Designated as safety issue: Yes ]
    Number of genital ulcers

  • Treatment failures [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Number of patients who fail to complete 6 months (treatment failures)

  • Oral ulcer pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Oral ulcer pain-Visual Analog Scale (VAS)

  • Side Effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Monitoring of side effects

  • MDHAQ [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Multidimensional health assessment questionnaire (MDHAQ)

  • BSAS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Behcet's syndrome activity score (BSAS)

  • BDCAF [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Behcet's disease current activity form (BDCAF) scores


Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: abatacept Drug: Abatacept
Weekly injections with Abatacept 125 mg over 6 months
Other Name: Orencia

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693640

Contacts
Contact: Margaret Andrew, RN, BSN 646-501-7380 margaret.andrew@nyumc.org

Locations
United States, New York
NYU Center for Musculoskeletal Care Recruiting
New York, New York, United States, 10016
Contact: Margaret Andrew, RN, BSN    646-501-7380    margaret.andrew@nyumc.org   
Principal Investigator: Yusuf Yazici, MD         
Sponsors and Collaborators
New York University School of Medicine
Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Yusuf Yazici, MD, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01693640     History of Changes
Other Study ID Numbers: IM101-280
Study First Received: September 19, 2012
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
Behcet's

Additional relevant MeSH terms:
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Vasculitis
Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014