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Low-dose IL-2 Treatment on Behcet's Disease

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ClinicalTrials.gov Identifier: NCT04065672
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Peking University People's Hospital

Brief Summary:
The study aims to explore the clinical and immunological efficacy of low-dose IL-2 on Behcet's Disease.

Condition or disease Intervention/treatment Phase
Behcet's Disease Drug: Low-dose IL-2 Phase 2

Detailed Description:
The investigators designed a single center, open-label, prospective study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines. One million units of rhIL-2 was administered subcutaneously five days every week for 4 weeks and then twice a week for 8 weeks. All patients were followed up for 3 months after treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-dose IL-2 Treatment on Behcet's Disease
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : March 20, 2021
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
Experimental: Low-dose IL-2
One million units of rhIL-2 was administered subcutaneously five days every week for 4 weeks and then twice a week for 8 weeks. All patients were followed up for 3 months after treatment.
Drug: Low-dose IL-2
One million units of rhIL-2 was administered subcutaneously five days every week for 4 weeks and then twice a week for 8 weeks. All patients were followed up for 3 months after treatment.




Primary Outcome Measures :
  1. Change in Regulatory T cells at week 12 compared to baseline. [ Time Frame: Week 12 ]
    Regulatory T cell was examined by flow cytometry and the marker is CD4+CD25+FoxP3+


Secondary Outcome Measures :
  1. Change from baseline in Behcet Syndrome Activity Scale (BSAS) Score. [ Time Frame: Week 12 and Week 24 ]
    The BSAS score comprises 10 items. Questions about oral ulcers (q1), genital ulcers (q3), skin lesions (q5), and current disease activity (q10) are scored from 0 to 10 (vi- sual analogue scale [VAS]), questions about the number of oral ulcers (q2), genital ulcers (q4), and skin lesions (q6) were scored as 0, 5, or 10, depending on which of the three were checked(0,n=0;5,n=1to3;10,n> 3 for q2 and q4; and n > 5 for q6), and questions about gastrointestinal/eye/vascular symptoms (q7, q8, and q9) were scored as 0 or 10, depending on whether or not they were present. The total score possible is 100.

  2. Change from baseline in physician global assessment activity [ Time Frame: Week 12 and Week 24 ]
    Physician's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the Behcet Syndrome

  3. Change from baseline in number of oral and genital ulcers [ Time Frame: Week 12 and Week 24 ]
    Ulcers will be examined by a physician.

  4. Change in C-reactive protein from baseline [ Time Frame: Week 12 and Week 24 ]
  5. Change in FoxP3+ Treg cell at week 12 and week 24 compared to baseline. [ Time Frame: Week 12 and Week 24 ]
  6. Change in steroid dose at week 12 and week 24 compared to baseline. [ Time Frame: Week 12 and Week 24 ]
  7. Change from baseline in simplified Behcet Disease Current Activity Form (BDCAF) Score [ Time Frame: Week 12 and Week 24 ]
    Simplified BDCAF score comprises 12 items of 10 systemic involvements. Question about headache, oral ulcers, genital ulcers, erythema, skin pustules, joints (arthralgia), joints (athritis), nausea/vomiting/abdominal pain, diarrhea with altered/frank blood per rectum, eye involvement, nervous system involvement, major vessel involvement are scored from 0 or 1 depending on the symptoms of previous 4 weeks by a physician. The total score possible is 12.

  8. Change from baseline in simplified electronic medical record -based activity index (EMRAI). [ Time Frame: Week 12 and Week 24 ]
    The EMRAI contains nine symptom scoring items and two laboratory results. Items include oral and genital ulcers, ocular symptoms, skin lesions, epididymitis, and symptoms related to the involvement of joints, the GI tract, the vascular system, and the central nervous system (CNS). laboratory results includ erythrocyte sedimentation rate (ESR) and C- reactive protein (CRP). The presence of each item, ESR and CRP are dichotomised as 0 or 1. The total score possible is 11.

  9. Change from baseline in Behcet's disease ocular inflammatory score 24 (BOS24) [ Time Frame: Week 12 and Week 24 ]
    Behcet's disease ocular attack score 24 (BOS24) consists of a total 24 points divided into 6 parameters of ocular inflammatory symptoms, including anterior chamber cells (maximum 4 points), vitreous opacity (maximum 4 points), peripheral fundus lesions (maximum 8 points), posterior pole lesions (maximum 4 points), subfoveal lesions (maximum 2 points), and optic disc lesions (maximum 2 points).

  10. Change from baseline in erythrocyte sedimentation rate [ Time Frame: Week 12 and Week 24 ]
    erythrocyte sedimentation rate

  11. Rate of mean change in DAIBD score of 20 or more from baseline. [ Time Frame: week12 ]
    This primary endpoint applies to intestinal BD patients.The DAIBD will be assessed by collecting information on 8 different intestinal BD-related variables. These 8 variables are: fever, abdominal mass, abdominal tenderness, intestinal complications, extraintestinal manifestations, general well-being, abdominal pain, and total number of liquid stools. The last 3 variables are scored over 7 days by the participant on a diary card. Abdominal pain will be measured using the 11-point numeric rating scale (NRS) to standardize the evaluation of pain and the result of 11-point NRS will be divided into 4 grades (none, mild, moderate, severe) to fill out the DAIBD. where, None indicate 0; Mild indicate 1-3; Moderate indicate 4-6; Severe indicate 7-10.

  12. Rate of equal or more than 20% changes in Visual acuity. [ Time Frame: week12 ]
    This primary endpoint applies to ocular involvement of BD patients.

  13. Rate of participants without oral and genital ulcers. [ Time Frame: Week 12 ]
    Ulcers will be examined by a physician.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥18 and ≤70 years of age at time of screening;
  2. Diagnosis of Behcet disease defined by the International Study Group Criteria of 1989;
  3. Patients who had active disease activity or intolerance after 3 months of conventional therapy; patients who had relapsed disease activity without treatment. Active manifestations including oral ulcers, genital ulcers, arthralgia, skin lesions and other systemic involvement manifestations. Intestinal BD-associated symptoms (abdominal pain, diarrhea, melena, etc.) and endoscopic evidence of active ulcers in the intestine. Aggravated visual acuity on a Snellen chart in at least one eye. Neurological BD (NBD) is classifies as either acute NBD (ANB) or chronic progressive NBD (CPNB) in accordance with the diagnostic criteria for NBD. Vascular BD (VBD) patients have active vasculitis lesions (deep vein thrombosis, aortic lesions, etc.) and abnormalities in inflammatory markers such as serum C-reactive protein (CRP) level and erythrocyte sedimentation rate (ESR) at enrollment.
  4. Apply glucocorticoids (≤1.0mg/Kg*d prednisone or equivalent doses of other hormones) for 4 weeks. DMARDs ( methotrexate, hydroxychloroquine, azathioprine, morphine, leflunomide, cyclosporine, mycophenolate mofeti ) need to stable for 4 weeks. Other medications, such as, IVIg and cyclophosphamide need to more than 2 months, Rituximab for 6 months, other biological agents (infliximab, adalimumab, etanercept, anakinra, etc.) for 3 months.
  5. Have given written informed consent and patients are expected to be able to comply with the requirements of the study follow-up plan and other protocols.

Exclusion Criteria:

  1. Stable disease activity;
  2. Received glucocorticoid >1.0mg/Kg*d within 4 weeks, used rituximab within 6 months and other biological agents within 3 months.
  3. Severe comorbidities: including Heart failure (≥ grade III NYHA); Renal insufficiency (creatinine clearance ≤30 ml/min); Hepatic insufficiency (serum ALT or AST >3 times the ULN, or total bilirubin >ULN for the central laboratory conducting the test).

    Other disease including hematopathy, gastrointestinal disease, endocrinopathy, pulmonary, neuropathy.

  4. Known allergies, hypersensitivity, or intolerance to IL-2 or its excipients.
  5. Severe infection, such as hepatitis, HIV, syphilis, pneumonia, bacteremia, cytomegalovirus and so on.
  6. Malignancy;
  7. Had uncontrolled psychiatric or emotional disorder;
  8. Pregnant or breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065672


Contacts
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Contact: Jiali Chen, MD +8618801206400 chenjiali0389@163.com
Contact: Jing He, MD 8618611707347 hejing1105@126.com

Locations
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China
Department of Rheumatology and Immunology, Peking University People's Hospital Recruiting
Beijing, China
Contact: Jiali Chen, MD    +8618801206400    chenjiali0389@163.com   
Contact: Jing He, MD    8618611707347    hejing1105@126.com   
Principal Investigator: Zhanguo Li, MD,PhD         
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Zhanguo Li, MD,PhD Department of Rheumatology and Immunology, Peking University People's Hospital.
Additional Information:
Publications:
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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04065672    
Other Study ID Numbers: 2019PHB089-03
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University People's Hospital:
ulcers
Additional relevant MeSH terms:
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Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular