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CompletedNCT01497717Updated Oct 26, 2016

Efficacy of Humira in Behcet Patients With Arthritis

A Phase 3 interventional study of Adalimumab (Humira) in Arthritis; Behcet, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-10-26.

Sponsored by Rambam Health Care Campus · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Arthritis; Behcet
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 9 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Adalimumab, Behcet with arthritis

    Drug: Adalimumab (Humira)

Interventions

  • DrugAdalimumab (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.

    Also known as: Anti TNF monoclonal antibodies

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Week 24

07

Study locations

1 site
  • Rheumatology Unit, Rambam Health Care Campus
    Haifa, 31096, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01497717
Lead sponsor
Rambam Health Care Campus
Collaborators
Abbott
Responsible party
Dr. Yolanda Braun (Senior Rheumatologist, Rambam Health Care Campus) — Principal investigator
First posted
Dec 22, 2011
Start date
Jul 2013
Primary completion
Oct 2016
Completion
Oct 2016
Last update
Oct 26, 2016

Study contacts

Yolanda Braun, MD
principal investigator · Rheumatology Unit, Rambam Health Care Campus, B. Rappaport Faculty of Medicine, Technion - Institute of Technology, Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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