NCT01497717

Efficacy of Humira in Behcet Patients With Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

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. 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.

Conditions

• Arthritis; Behcet

Interventions

Type	Name	Description
DRUG	Adalimumab (Humira)	Open label pilot trial. The study includes 3 phases : 1. Open label treatment period of 24 weeks. 2. Extension follow -up (3 years): Patients who responded well to study drug and their disease relapsed within the first 12 weeks following study drug interruption will be eligible to receive the study drug for 3 years in order to comply with the Israeli Ministry of Health requirements. 3. Safety follow-up: For patients who withdraw from either the open label treatment period or extension period, for another 24 weeks.

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2011-12-22
• Last updated: 2016-10-26

Locations

1 site across 1 country: Israel