Status:
COMPLETED
Efficacy of Humira in Behcet Patients With Arthritis
Lead Sponsor:
Rambam Health Care Campus
Collaborating Sponsors:
Abbott
Conditions:
Arthritis; Behcet
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Hypothesis - Behcet's disease is a multisystemic chronic relapsing inflammatory disease, classified among the vasculitides. The clinical manifestations include mucocutaneous lesions, articular, ocular...
Detailed Description
Study Design (including visit schedule, dosing and procedures/methods): Screen visit, 1st visit -treatment initiation, follow-up visits - after 1 month and afterwards every 8 weeks for 24 weeks. Scr...
Eligibility Criteria
Inclusion
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
- Patients with Behcet disease ,who fulfilled the International Study group criteria for Behcet Disease.
- Experienced an inadequate response to previous or current treatment with one or more DMARDs because of inadequate efficacy or side effects.
- DMARDS and/or corticosteroids (\< or equivalent to 10mg/d prednisone) permitted if stable for at least 4 weeks prior to screening. NSAIDs permitted if stable for at least 2 weeks prior to screening.
- Active peripheral arthritis at screening (tenderness and swelling of at least 3 small joints or one large joint) OR axial involvement (active enthesitis or spondylitis)
- Age 18-80 years.
- If female and of childbearing potential, a negative urine pregnancy test within 2 weeks prior to therapy, and using reliable means of contraception.
Exclusion
- Rheumatic autoimmune disease other than Behcet (Rheumatoid arthritis, SLE, scleroderma, etc).
- Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders.
- Known active bacterial, viral, fungal, mycobacterial or other infection, or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
- History of lymphoproliferative or hematologic malignancy. History of any other type of cancer in the past 5 years.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01497717
Start Date
July 1 2013
End Date
October 1 2016
Last Update
October 26 2016
Active Locations (1)
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1
Rheumatology Unit, Rambam Health Care Campus
Haifa, Israel, 31096