Back to resultsInterferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis
Primary Purpose
Behçet Disease, Uveitis
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Interferon Alfa-2A
Cyclosporine Pill
Sponsored by
About this trial
This is an interventional treatment trial for Behçet Disease focused on measuring effectiveness, safety
Eligibility Criteria
Inclusion Criteria:
- Refractory BDU patients fulfilling the International Criteria for Behçet's disease (ICBD) published in 2013 with recent recurrence of pan- or posterior uveitis;
- The patient should be on ≥10mg/d oral prednisone or equivalent with at least one of the following IMT agents: cyclophosphamide≥50mg/d, CsA≥100mg/d, azathioprine≥50mg/d, methotrexate≥15mg/w, mycophenolate≥1000mg/d, tacrolimus≥2mg/d.
Exclusion Criteria:
- Previous treatment with interferon-α;
- Pregnancy, breast feeding women;
- Malignancy;
- Renal impairment (creatinine > 1.5 mg/dl);
- Uncontrolled hypertension or diabetes;
- Depression or other psychic disorders;
- History of acute or chronic inflammatory joint or autoimmune disease;
- Patients with severe extra-ocular involvement other than oral/genital ulcer and skin involvement;
- Organ or bone marrow transplant recipient, cardiac failure > NYHA III;
- Acute liver disease with ALT or SGPT 2x above normal;
- White blood cell count < 3500/mm^3;
- Platelet count < 100000/mm^3;
- Hgb < 8.5g/dl;
- T-SPOT TB: ≥200 SFCs per 10^6 PBMC;
- Active peptic ulcer, systemic or local infection, moderate to severe osteoporosis or other contraindications of large dose corticosteroids;
- Previous intolerance to CsA;
- Other severe ocular diseases or intraocular surgery within 3 months;
- Media opacity precluding a clear view of the fundus;
- Positive screen test for HBV, HCV, HIV infection or syphilis;
- Body weight <45 kg;
- Alcohol abuse or drug abuse;
- Mental impairment;
- Uncooperative attitude.
Sites / Locations
- Peking Union Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interferon Alpha 2A
Cyclosporine
Arm Description
Patients are treated with IFNα2a 3×10^IU α2a by subcutaneous injection or intramuscular injection daily for 4 weeks, and followed by every other day there after.
Patients are treated with oral CsA 100mg twice daily.
Outcomes
Primary Outcome Measures
Response rate
Percentage of participants who achieve complete remission or partial remission
Complete remission rate
Percentage of participants who achieve complete remission without relapse of posterior or pan-uveitis
Tolerance rate
Percentage of participants who adhere to the treatment without severe side effects
Secondary Outcome Measures
Time to reach complete remission
The time from the therapy initiation to a complete absence of ocular inflammation for complete responders
Duration of relapse-free
The duration between the therapy initiation to the relapse for partial responders and nonresponders
BCVA
Changes of best-corrected visual acuity
BOS24 score
Score of ocular inflammation using the Behcet disease ocular attack score 24 (BOS24)
Glucocorticoid-sparing effect
Changes of corticosteroid dosage
Incidence of adverse effects
Incidence of adverse effects
Incidence of significant abnormal changes in vital signs or laboratory test results
Incidence of significant abnormal changes in vital signs or laboratory test results
Adverse effects profile
Types of drug adverse effects
Full Information
NCT ID
NCT03209219
First Posted
July 4, 2017
Last Updated
February 20, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03209219
Brief Title
Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis
Official Title
Randomized Prospective Comparative Study of Interferon α2a and Cyclosporine in Patients With Refractory Behçet's Disease Uveitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Brief summary: This study compares the long-term efficacy and safety of interferon (IFN) α2a and cyclosporine (cyclosporin A, CsA) following suppression of acute attack by high-dose oral glucocorticosteroid in patients with refractory Behçet's uveitis (BDU). Half of the participants will receive IFNα2a while the other half will receive CsA.
Detailed Description
Detailed description: Both CsA and IFNα2a have been shown to be effective for long-term control of BDU, however, randomized prospective comparative studies are scarce, particularly in East Asian populations. Our preliminary data gave us the impression that IFNα2a might be more effectiveness than CsA in long-term control of refractory BDU, and this study aimed to compare their effectiveness and safety profiles in a well-designed prospective study. Refractory BDU is defined as relapse of posterior or pan- uveitis with at least 10mg daily prednisone (or equivalent) and one traditional immunomodulatory treatment (IMT) agents. The acute attack is controlled with large dose oral corticosteroid (60mg daily prednisone) for 4 weeks, and then the patients are randomly assigned to the IFN arm and the CsA arm, in which patients are treated with IFNα2a (3×10^6 IU qd for 4 weeks and qod thereafter) and CsA (100mg bid), respectively, along with a fixed tapering regimen of corticosteroid. Patients were followed up until relapse, or for 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behçet Disease, Uveitis
Keywords
effectiveness, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interferon Alpha 2A
Arm Type
Experimental
Arm Description
Patients are treated with IFNα2a 3×10^IU α2a by subcutaneous injection or intramuscular injection daily for 4 weeks, and followed by every other day there after.
Arm Title
Cyclosporine
Arm Type
Active Comparator
Arm Description
Patients are treated with oral CsA 100mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Interferon Alfa-2A
Intervention Description
3×10^6 IU， subcutaneous or intramuscular injection, qd for × 4 weeks, and qod thereafter
Intervention Type
Drug
Intervention Name(s)
Cyclosporine Pill
Intervention Description
100mg， oral, bid
Primary Outcome Measure Information:
Title
Response rate
Description
Percentage of participants who achieve complete remission or partial remission
Time Frame
Within the 12-month follow-up period
Title
Complete remission rate
Description
Percentage of participants who achieve complete remission without relapse of posterior or pan-uveitis
Time Frame
Within the 12-month follow-up period
Title
Tolerance rate
Description
Percentage of participants who adhere to the treatment without severe side effects
Time Frame
Within the 12-month follow-up period
Secondary Outcome Measure Information:
Title
Time to reach complete remission
Description
The time from the therapy initiation to a complete absence of ocular inflammation for complete responders
Time Frame
Within the 12-month follow-up period
Title
Duration of relapse-free
Description
The duration between the therapy initiation to the relapse for partial responders and nonresponders
Time Frame
within the 12-month follow-up period
Title
BCVA
Description
Changes of best-corrected visual acuity
Time Frame
Within the 12-month follow-up period
Title
BOS24 score
Description
Score of ocular inflammation using the Behcet disease ocular attack score 24 (BOS24)
Time Frame
Within the 12-month follow-up period
Title
Glucocorticoid-sparing effect
Description
Changes of corticosteroid dosage
Time Frame
Within the 12-month follow-up period
Title
Incidence of adverse effects
Description
Incidence of adverse effects
Time Frame
Within the 12-month follow-up period
Title
Incidence of significant abnormal changes in vital signs or laboratory test results
Description
Incidence of significant abnormal changes in vital signs or laboratory test results
Time Frame
Within the 12-month follow-up period
Title
Adverse effects profile
Description
Types of drug adverse effects
Time Frame
Within the 12-month follow-up period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Refractory BDU patients fulfilling the International Criteria for Behçet's disease (ICBD) published in 2013 with recent recurrence of pan- or posterior uveitis;
The patient should be on ≥10mg/d oral prednisone or equivalent with at least one of the following IMT agents: cyclophosphamide≥50mg/d, CsA≥100mg/d, azathioprine≥50mg/d, methotrexate≥15mg/w, mycophenolate≥1000mg/d, tacrolimus≥2mg/d.
Exclusion Criteria:
Previous treatment with interferon-α;
Pregnancy, breast feeding women;
Malignancy;
Renal impairment (creatinine > 1.5 mg/dl);
Uncontrolled hypertension or diabetes;
Depression or other psychic disorders;
History of acute or chronic inflammatory joint or autoimmune disease;
Patients with severe extra-ocular involvement other than oral/genital ulcer and skin involvement;
Organ or bone marrow transplant recipient, cardiac failure > NYHA III;
Acute liver disease with ALT or SGPT 2x above normal;
White blood cell count < 3500/mm^3;
Platelet count < 100000/mm^3;
Hgb < 8.5g/dl;
T-SPOT TB: ≥200 SFCs per 10^6 PBMC;
Active peptic ulcer, systemic or local infection, moderate to severe osteoporosis or other contraindications of large dose corticosteroids;
Previous intolerance to CsA;
Other severe ocular diseases or intraocular surgery within 3 months;
Media opacity precluding a clear view of the fundus;
Positive screen test for HBV, HCV, HIV infection or syphilis;
Body weight <45 kg;
Alcohol abuse or drug abuse;
Mental impairment;
Uncooperative attitude.
Facility Information:
Facility Name
Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The individual participant data are available from the investigator upon reasonable request.
Learn more about this trial
Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis
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