Arthritis; Behcet Clinical Trial
Official title:
Efficacy of Humira in Behcet Patients With Arthritis
| Verified date | October 2016 |
| Source | Rambam Health Care Campus |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ethics Commission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | October 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rheumatology Unit, Rambam Health Care Campus | Haifa |
| Lead Sponsor | Collaborator |
|---|---|
| Rambam Health Care Campus | Abbott |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction in DAS28 | The proportion of patients with improvement in arthritis (DAS 28) at week 24 -changes from screening in DAS 28 , HAQ, , CRP. ANOVA analysis and descriptive statistics. An interim evaluation of the above parameters will be performed at week 16 (visit 4) and yearly afterwards for 3 more years in those patients who will continue drug study during the extension period | Week 24 | No |