Efficacy of Humira in Behcet Patients With Arthritis

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Collaborator: Abbott
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

1. Able and willing to give written informed consent and comply with the requirements of the study protocol.

2. Patients with Behcet disease ,who fulfilled the International Study group criteria for Behcet Disease.

3. Experienced an inadequate response to previous or current treatment with one or more DMARDs because of inadequate efficacy or side effects.

4. 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.

5. 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)

6. Age 18-80 years.

7. If female and of childbearing potential, a negative urine pregnancy test within 2 weeks prior to therapy, and using reliable means of contraception.

Exclusion Criteria:

1. Rheumatic autoimmune disease other than Behcet (Rheumatoid arthritis, SLE, scleroderma, etc).

2. Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders.

3. 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.

4. History of lymphoproliferative or hematologic malignancy. History of any other type of cancer in the past 5 years.