Efficacy of Humira in Behcet Patients With Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01497717
Recruitment Status : Completed
First Posted : December 22, 2011
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):
Dr. Yolanda Braun, Rambam Health Care Campus

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, 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.

Condition or disease Intervention/treatment Phase
Arthritis; Behcet Drug: Adalimumab (Humira) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Humira in Behcet Patients With Arthritis
Study Start Date : July 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: Adalimumab, Behcet with arthritis 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.
Other Name: Anti TNF monoclonal antibodies

Primary Outcome Measures :
  1. Reduction in DAS28 [ Time Frame: Week 24 ]
    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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01497717

Rheumatology Unit, Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Principal Investigator: Yolanda Braun, MD Rheumatology Unit, Rambam Health Care Campus, B. Rappaport Faculty of Medicine, Technion - Institute of Technology, Israel

Responsible Party: Dr. Yolanda Braun, Senior Rheumatologist, Rambam Health Care Campus Identifier: NCT01497717     History of Changes
Other Study ID Numbers: 0488-09RMB
A06-197 ( Other Identifier: Protocol Number of Collaborator - Abbott Company )
First Posted: December 22, 2011    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Behcet Syndrome
Joint Diseases
Musculoskeletal Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Anti-Inflammatory Agents
Antirheumatic Agents