Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of natural human interferon alpha (IFN alpha) on size, number, incidence and pain of oral ulcers associated with Behçet's Disease (BD).

Clinical Trial Description

Behçet's disease is a severe chronic relapsing inflammatory disorder marked by oral and genital ulcers, uveitis and skin lesions, as well as varying multisystem involvement including the joints, blood vessels, central nervous system, and gastrointestinal tract. Oral ulcers are the initial symptom for most of Behçet's cases and are the single manifestation of the disease required for an official diagnosis, along with two other hallmark symptoms.

Ninety (90) patients will be enrolled in a randomized, parallel, double-blind, placebo-controlled study to evaluate the effectiveness of low dose natural human IFN α administered by the oral mucosal route in reducing the number, size, incidence and pain of oral ulcers in patients with Behçet's disease.

The clinical trial will consist of 3 groups of patients randomized in a 1:1:1 ratio to twice daily receive 2 lozenges containing 500 IU IFN α(2,000 IU daily, n=30), one active (500 IU) and one placebo lozenge (1,000 IU daily, n=30) or 2 placebo lozenges (n=30). Subjects will be monitored weekly over an initial 4 weeks of treatment and then bi-weekly over an additional 8 weeks of treatment. Medication will be self-administered as 2 lozenges taken twice daily (morning and evening). Oral lesions will be counted and measured at each study visit, and patients will answer a series of questionnaires. Results will be subjected to statistical analysis at the completion of the study, with change in total ulcer burden of a patient, a measurement of the total oral mucosal surface area involved with ulcerous lesions at each visit, serving as the primary endpoint. The total ulcer burden from each treated visit will be compared to the baseline total ulcer burden and the amount of change determined. Patients with a 75% decrease in total ulcer burden will be considered responders. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00483184
Study type	Interventional
Source	Nobel Pharmaceuticals
Contact
Status	Completed
Phase	Phase 2
Start date	April 2006
Completion date	April 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03274648` - Dietary Interventions and Butyrate Production in Behçet's Patients	N/A
Terminated	`NCT01693653` - Tocilizumab for the Treatment of Behcet's Syndrome	Phase 2
Completed	`NCT04961463` - Evaluation of the Psychoeducation Program Given to Behcet's Patients in the Context of the Roy Adaptation Model	N/A
Completed	`NCT05142995` - Sleep Related Breathing Disorders, Anxiety, Depression and Quality of Life Assessment in Behcet's Disease
Recruiting	`NCT00931957` - Etanercept: Single Blind Control Study in Ocular Manifestations of Behcet's Disease	N/A
Completed	`NCT03514056` - Frequency of Fibromyalgia in Behcet Disease
Not yet recruiting	`NCT03771768` - Diode Laser Versus Topical Corticosteroids in Management of Oral Ulcers in Behcet's Disease	N/A
Terminated	`NCT03554161` - Tocilizumab for the Treatment of Refractory Behcet's Uveitis	Phase 2
Recruiting	`NCT04738864` - Neuro-ultrasound Assessment in Behcet's Disease	N/A
Completed	`NCT03264391` - Evaluation of Macular Vascular Changes in Behcet's Disease Using Optical Coherence Tomography Angiography
Completed	`NCT04386824` - Erectile Dysfunction in Patients With Non Ocular Behçet's Disease
Completed	`NCT03962335` - Gut Microbiota and Behcet's Syndrome: a Dietary Intervention Trial (MAMBA Study)	N/A
Completed	`NCT01532570` - Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions	Phase 3
Not yet recruiting	`NCT04186559` - Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers	Phase 2
Terminated	`NCT04218565` - Golimumab for the Treatment of Refractory Behcet's Uveitis	Phase 2
Not yet recruiting	`NCT03747354` - Assessment of Disease Activity in Behcet by Complete Blood Count	N/A
Recruiting	`NCT05200715` - AutoInflammatory Disease Alliance Registry (AIDA)
Completed	`NCT05098678` - Zinc Supplementation and Behçet's Syndrome	N/A
Completed	`NCT00866359` - A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease	Phase 2
Completed	`NCT05032248` - Uses of Tacrolimus in Behcet Disease	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.