Status:
COMPLETED
Anakinra for Behcet s Disease
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Autoimmune Connective Tissue Disorder
Immune System Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: \- Behcet's disease (BD) is an autoimmune disease where the immune system attacks the body. People with BD may develop oral or genital ulcers, skin problems, and eye disease. Most drugs u...
Detailed Description
Autoinflammatory diseases are illnesses characterized by episodes of inflammation that, unlike autoimmune disorders, lack the production of high titer autoantibodies or antigen-specific T cells. There...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Male or female subjects with BD associated inflammatory disease greater than or equal 18 years of age
- Participation in NIH study #03-AR-0173 ( Studies of the Natural History, Pathogenesis, and Outcome of Autoinflammatory Diseases )
- Diagnosis of Behcet s disease as determined by the International Study Group Criteria \[17\] or by complete Japanese Criteria \[18\].
- Active mucocutaneous disease as defined by at least one oral or genital ulcer within the past month.
- Stable dose of steroids, NSAIDs, DMARDs, or colchicine for four weeks prior to enrollment visit.
- For patients with ocular disease, no active intermediate or posterior disease at enrolment but history of an ocular flare (greater than or equal to 3 in the last 6 months) in the presence of any systemic anti-inflammatory therapy such as prednisone, azathioprine, Mycophenolate, methotrexate, cyclosporine, a tumor necrosis factor (TNF) inhibitor, or a combination of these medications. Patients must have developed active disease in the presence of at treatment with at least one of the following medications for at least six months: azathioprine, cyclosporine, or a TNF inhibitor.
- Females of childbearing potential (young women who have had at least one menstrual period regardless of age) must have a negative urine pregnancy test at screening and a negative serum pregnancy test at baseline prior to performance of any radiologic procedure or administration of study medication. Female patients will be screened for pregnancy at all NIH visits.
- Women of childbearing age and men able to father a child, who are sexually active, who agree to use a form of effective birth control, including abstinence.
- Either (1) a negative PPD test using 5 T.U. intradermal testing per Center for Disease Control and Prevention guidelines and no evidence of active tuberculosis (TB) on chest X-ray at the time of enrollment or (2) a positive PPD with no evidence of active TB by history or on chest X-ray at the time of enrollment and either past or present treatment with adequate therapy for at least one month prior to first dose of study medication. Full prophylaxis regimens will be completed. Subjects who have been Bacillus Calmette-Guerin (BCG)-vaccinated will also be skin-tested.
- Able to understand, and complete study-related questionnaires.
- Able and willing to give informed consent and abide with the study procedures.
- EXCLUSION CRITERIA:
- Treatment with a live virus vaccine during 3 months prior to baseline visit. No live vaccines will be allowed throughout the course of this study.
- Patients with ocular disease who received local treatments other than eye drops (i.e. periocular or intraocular steroids, implants or other anti-inflammatory agents within 4 weeks prior to enrolment)
- Current treatment with TNF inhibitors or discontinuation of TNF inhibitors within 8 weeks.
- Presence of active infections or a history of pulmonary TB infection. Patients with a history of exposure to TB (positive PPD) who have not been treated with a TB prophylaxis regimen for at least one month.
- Chest x-ray read by a radiologist with pleural scarring and/or calcified granuloma consistent with prior TB.
- Positive test for or prior history of HIV, Hepatitis B or C.
- History or concomitant diagnosis of congestive heart failure.
- History of malignancy. Subjects deemed cured of superficial malignancies such as cutaneous basal or squamous cell carcinomas, or in situ cervical cancer may be enrolled.
- Known hypersensitivity to Chinese Hamster Ovary (CHO) cell derived biologicals or any components of anakinra.
- Presence of any additional rheumatic disease or significant systemic disease. For example, major chronic infectious/ inflammatory/ immunologic disease (such as inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, systemic lupus erythematosus in addition to autoinflammatory disease).
- Presence of any of the following laboratory abnormalities at enrollment visit: creatinine \> 1.5 times the upper limit of normal , white blood cell \< 3.6 times10(9)/mm(3); platelet count \< 75,000 mm(3); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.0 times the upper limit of normal
- Lactating females or pregnant females.
- Subjects with asthma not adequately controlled on current inhaled therapy for at least four weeks.
- Enrollment in any other investigational treatment study or use of an investigational agent, or has not yet completed at least 4 weeks or 5 half-lives, whichever is longer, since ending another investigational device or drug trial.
- Subjects for whom there is concern about compliance with the protocol procedures.
- Presence of other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject s safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
- Treatment within the past 12 months with canakinumab
- Active neurologic disease which would require cyclophosphamide treatment. Active neurologic disease is defined as either new evidence of parenchymal (meningoencephalitis) or non-parenchymal (vascular complications including thrombosis) disease.
- Subjects who experience an end organ flare after discontinuation of a TNF inhibitor as part of this study.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01441076
Start Date
September 1 2011
End Date
November 1 2014
Last Update
May 12 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892