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

NCT01693640 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 10-02611
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Female Patients With Behcet's Syndrome

Keywords

Behcet's

Outcome Measures

Primary Outcomes (1)

• ulcers

  The primary endpoint is number of oral and genital ulcers (AUC) during the treatment period

  6 month treatment period

Secondary Outcomes (7)

• Genital ulcers

  6 month treatment

• Treatment failures

  6 months

• Oral ulcer pain

  6 months

• Side Effects

  6 months

• MDHAQ

  6 months

Study Arms (1)

abatacept

EXPERIMENTAL

Drug: Abatacept

Interventions

Abatacept DRUG

Weekly injections with Abatacept 125 mg over 6 months

Also known as: Orencia

abatacept

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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).

Sponsors & Collaborators

• NYU Langone Health: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

NYU Center for Musculoskeletal Care

New York, New York, 10016, United States

Location

Related Links

• NYU Center for Musculoskeletal Care

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 26, 2012
• Study Start: June 1, 2012
• Primary Completion: December 28, 2018
• Study Completion: December 28, 2018
• Last Updated: January 28, 2019

Record last verified: 2019-01

Locations

US (1)