- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693640
A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Behcet's Syndrome
January 25, 2019 updated by: NYU Langone Health
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
3
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Center for Musculoskeletal Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria
- 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.
Exclusion Criteria:
- 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).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: abatacept
|
Weekly injections with Abatacept 125 mg over 6 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ulcers
Time Frame: 6 month treatment period
|
The primary endpoint is number of oral and genital ulcers (AUC) during the treatment period
|
6 month treatment period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genital ulcers
Time Frame: 6 month treatment
|
Number of genital ulcers
|
6 month treatment
|
Treatment failures
Time Frame: 6 months
|
Number of patients who fail to complete 6 months (treatment failures)
|
6 months
|
Oral ulcer pain
Time Frame: 6 months
|
Oral ulcer pain-Visual Analog Scale (VAS)
|
6 months
|
Side Effects
Time Frame: 6 months
|
Monitoring of side effects
|
6 months
|
MDHAQ
Time Frame: 6 months
|
Multidimensional health assessment questionnaire (MDHAQ)
|
6 months
|
BSAS
Time Frame: 6 months
|
Behcet's syndrome activity score (BSAS)
|
6 months
|
BDCAF
Time Frame: 6 months
|
Behcet's disease current activity form (BDCAF) scores
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2012
Primary Completion (ACTUAL)
December 28, 2018
Study Completion (ACTUAL)
December 28, 2018
Study Registration Dates
First Submitted
September 19, 2012
First Submitted That Met QC Criteria
September 24, 2012
First Posted (ESTIMATE)
September 26, 2012
Study Record Updates
Last Update Posted (ACTUAL)
January 28, 2019
Last Update Submitted That Met QC Criteria
January 25, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Eye Diseases
- Disease
- Genetic Diseases, Inborn
- Stomatognathic Diseases
- Mouth Diseases
- Uveitis, Anterior
- Panuveitis
- Uveitis
- Uveal Diseases
- Vasculitis
- Hereditary Autoinflammatory Diseases
- Skin Diseases, Genetic
- Skin Diseases, Vascular
- Syndrome
- Behcet Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Immune Checkpoint Inhibitors
- Abatacept
Other Study ID Numbers
- 10-02611
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Female Patients With Behcet's Syndrome
-
Kasr El Aini HospitalCompletedFemale Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary IncontinenceEgypt
-
Meir Medical CenterUnknownPatients With Normal ECG | Patients With Pathological ECGIsrael
-
Hadassah Medical OrganizationUnknownFemale Patients Aged 5-35 Prior to Systemic Chemotherapy | With Significant Risk of Ovarian ToxicityIsrael
-
Mehmet GÖĞREMİŞKahramanmaras Sutcu Imam UniversityCompletedFemale Patients Diagnosed With LDH at L4-S1Turkey
-
Centre Hospitalier Universitaire DijonCompletedPatients Undergoing Cardiac Surgery | Patients With Coronary Artery Bypass Surgery With CECFrance
-
Far Eastern Memorial HospitalRecruitingFemale Patients With Overactive Bladder SyndromeTaiwan
-
Centre Francois BaclesseRecruitingPatients With CancerFrance
-
Yonsei UniversityRecruitingPatients With DefibrillatorKorea, Republic of
-
Philogen S.p.A.TerminatedPatients With CancerItaly, United Kingdom
-
Rennes University HospitalTerminated
Clinical Trials on Abatacept
-
Bristol-Myers SquibbCompletedUlcerative ColitisUnited States, Australia, India, Korea, Republic of, Poland, Canada, France, Brazil, Mexico, Puerto Rico, Belgium, Switzerland, Italy, Netherlands, Germany, Ireland, South Africa, United Kingdom, Czech Republic
-
University Medical Center GroningenBristol-Myers SquibbCompletedSjögren's SyndromeNetherlands
-
Melbourne HealthNational Health and Medical Research Council, Australia; Juvenile Diabetes...Active, not recruitingDiabetes Mellitus, Type 1 | Type 1 DiabetesAustralia
-
Bristol-Myers SquibbCompletedRheumatoid ArthritisUnited States
-
National Institute of Allergy and Infectious Diseases...Immune Tolerance Network (ITN)CompletedMultiple Sclerosis, Relapsing-RemittingUnited States, Canada
-
Rüdiger B. MüllerBristol-Myers SquibbCompletedRheumatoid ArthritisSwitzerland
-
Karolinska InstitutetKing's College Hospital NHS Trust; Institute of Rheumatology, PragueCompletedDermatomyositis | PolymyositisSweden, Czechia
-
Bristol-Myers SquibbCompleted
-
Bristol-Myers SquibbCompletedRheumatoid ArthritisUnited States
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceCompleted