Arthritis; Behcet Clinical Trial
Official title:
Efficacy of Humira in Behcet Patients With Arthritis
Hypothesis - Behcet's disease is a multisystemic chronic relapsing inflammatory disease,
classified among the vasculitides. The clinical manifestations include mucocutaneous
lesions, articular, ocular, vascular, gastrointestinal and/or central nervous system
involvement.
The aetiology of Behcet's disease is unknown, however. Experimental evidence suggests that
TNF-α may play an important role in the pathogenesis of the disease.
To date, case reports and small open-short term studies report the efficacy of anti-TNFα
therapy (Infliximab and Etanercept), especially regarding ocular and mucocutaneous
involvement in Behcet.
There are no double blind long term studies on larger number of patients regarding the
efficacy of anti-TNFα, especially Humira in healing arthritis +/- other manifestations of
the disease.
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.
Screen visit: informed consent, medical history,inclusion and exclusion criteria, pregnancy
test, vital signs, physical examination, joint evaluation (no. of tender joints, no. of
swollen joints), patient/investigator global disease activity, pain VAS, HAQ, Behcet Disease
Current Activity Forms (BDACF), ECG, PPD and chest X-ray screening for tuberculosis, routine
labs (performed at local HMO as a routine follow-up of the patient treatment with DMARD's):
CBC, blood chemistry, ESR, CRP, urinalysis, HbsAg and AntiHCV, immunology labs (rheumatoid
factor, anti-CCP, anti nuclear antibody - ANA).
An induration of greater than 5 mm will be considered a positive PPD reaction.
Follow up visits .: Vital signs, joint evaluation, patient/investigator global disease
activity, pain VAS, HAQ, BDACF, routine labs (performed at local HMO as a routine follow-up
of the patient treatment with DMARD's): CBC, blood chemistry, ESR, CRP, urinalysis, research
blood samples for storage.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment