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Efficacy of Humira in Behcet Patients With Arthritis

This study is not yet open for participant recruitment.
Verified June 2012 by Rambam Health Care Campus
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Dr. Yolanda Braun, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01497717
First received: December 20, 2011
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Arthritis; Behcet
 Drug: Adalimumab (Humira)
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Humira in Behcet Patients With Arthritis

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Reduction in DAS28 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 15
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 arthritis at screening (tenderness and swelling of at least 3 small joints or one large joint.
  6. At screening either CRP>1.5mg/dl or ESR >28mm/h.
  7. Age 18-80 years.
  8. 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.
  5. Pregnant women or nursing (breast feeding) mothers.
  6. Positive tests for hepatitis B surface antigen or hepatitis C antibody.
  7. History of demyelinating disease.
  8. Active tuberculosis (TB) or history of untreated active TB. If patient has latent TB based on PPD and chest x-ray results at screening, TB prophylaxis therapy (isoniazid or rifampin) must be initiated prior to administration of adalimumab.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497717

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

No publications provided

Responsible Party: Dr. Yolanda Braun, Senior Rheumatologist, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01497717     History of Changes
Other Study ID Numbers: 0488-09RMB, A06-197
Study First Received: December 20, 2011
Last Updated: June 14, 2012
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Arthritis
Behcet Syndrome
Joint Diseases
Musculoskeletal Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
 Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Antibodies, Monoclonal
Adalimumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 17, 2013