NCT01497717|CompletedPhase 3
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Sponsor study identifier
Secondary identifiers
OTHER · Protocol Number of Collaborator - Abbott Company
interventional
9
1 country
1
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2016
Actual (reported)Study Completion
October 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2011
Actual (reported)December 22, 2011
Actual (reported)July 2013
Date type not reportedThis date has not been verified as actual or estimated.
October 2016
Actual (reported)October 2016
Actual (reported)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
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.
Rheumatology Unit, Rambam Health Care Campus
Haifa, 31096, Israel
Yolanda Braun, MD
Rheumatology Unit, Rambam Health Care Campus, B. Rappaport Faculty of Medicine, Technion - Institute of Technology, Israel
9 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2011
First Posted
December 22, 2011
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Continuing Versus Withdrawing Adalimumab in Maintaining Remission in Non-Radiographic Axial Spondyloarthritis
Contact the study team to confirm eligibility.
Primary Completion
October 2016
Actual (reported)Study Completion
October 2016
Actual (reported)Last Updated
October 26, 2016
Record last verified: 2016-10
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Source: ClinicalTrials.gov.
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