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Efficacy of Humira in Behcet Patients With Arthritis

NCT01497717 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-10-26

No results posted yet for this 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.

Conditions

  • Arthritis; Behcet

Interventions

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.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Israel

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01497717 on ClinicalTrials.gov