Anakinra for Behcet s Disease

Completed · Phase 1/Phase 2

Conditions studied: Autoimmune Connective Tissue Disorder, Immune System Diseases

In brief

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 used to treat BD suppress the immune system, but they are not always helpful and may have side effects. A new drug, anakinra, may be able to treat BD with fewer side effects. Because it has not been studied in people with BD, anakinra is considered an experimental treatment. Objectives: \- To test whether anakinra can be a safe and effective treatment for Behcet s disease. Eligibility: \- People who have Behcet's disease with ongoing oral or genital ulcers for at least one month, or three or more flares of eye disease in the past 6 months. Design: * Participants will be screened with a physical exam and medical history. They will also have blood and urine tests. They will be divided into two groups: those with oral or genital ulcers and those with eye disease. * All participants will keep a diary of symptoms for a month before starting the study drug. * Participants with oral or genital ulcers will receive daily injections of anakinra for 3 to 6 months. Treatment will be monitored with frequent blood draws and daily diaries. Those who improve but do not have a full response to the drug may receive a higher dose. Those who improve after 6 months may have an extra 6 months on either anakinra or placebo to study the differences in response. * Participants with eye disease will receive anakinra for up to 12 months. Treatment will be monitored with frequent blood draws, daily diaries, and regular eye exams. * All participants will have a final study visit 1 month after stopping the study drug.

Key facts

Study ID

NCT01441076

Run by

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

People needed

6

Starts

2011-09-01

Expected to finish

2014-11-01

Last updated by the study team

2017-05-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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