Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis
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ClinicalTrials.gov Identifier: NCT03209219 |
Recruitment Status :
Completed
First Posted : July 6, 2017
Last Update Posted : February 23, 2021
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Condition or disease | Intervention/treatment | Phase |
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Behçet Disease Uveitis | Drug: Interferon Alfa-2A Drug: Cyclosporine Pill | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Prospective Comparative Study of Interferon α2a and Cyclosporine in Patients With Refractory Behçet's Disease Uveitis |
Actual Study Start Date : | June 30, 2017 |
Actual Primary Completion Date : | August 31, 2020 |
Actual Study Completion Date : | January 31, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Interferon Alpha 2A
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.
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Drug: Interferon Alfa-2A
3×10^6 IU, subcutaneous or intramuscular injection, qd for × 4 weeks, and qod thereafter |
Active Comparator: Cyclosporine
Patients are treated with oral CsA 100mg twice daily.
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Drug: Cyclosporine Pill
100mg, oral, bid |
- Response rate [ Time Frame: Within the 12-month follow-up period ]Percentage of participants who achieve complete remission or partial remission
- Complete remission rate [ Time Frame: Within the 12-month follow-up period ]Percentage of participants who achieve complete remission without relapse of posterior or pan-uveitis
- Tolerance rate [ Time Frame: Within the 12-month follow-up period ]Percentage of participants who adhere to the treatment without severe side effects
- Time to reach complete remission [ Time Frame: Within the 12-month follow-up period ]The time from the therapy initiation to a complete absence of ocular inflammation for complete responders
- Duration of relapse-free [ Time Frame: within the 12-month follow-up period ]The duration between the therapy initiation to the relapse for partial responders and nonresponders
- BCVA [ Time Frame: Within the 12-month follow-up period ]Changes of best-corrected visual acuity
- BOS24 score [ Time Frame: Within the 12-month follow-up period ]Score of ocular inflammation using the Behcet disease ocular attack score 24 (BOS24)
- Glucocorticoid-sparing effect [ Time Frame: Within the 12-month follow-up period ]Changes of corticosteroid dosage
- Incidence of adverse effects [ Time Frame: Within the 12-month follow-up period ]Incidence of adverse effects
- Incidence of significant abnormal changes in vital signs or laboratory test results [ Time Frame: Within the 12-month follow-up period ]Incidence of significant abnormal changes in vital signs or laboratory test results
- Adverse effects profile [ Time Frame: Within the 12-month follow-up period ]Types of drug adverse effects

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT03209219
China, Beijing | |
Peking Union Medical College | |
Beijing, Beijing, China, 100730 |
Responsible Party: | Meifen Zhang, Professor, Peking Union Medical College Hospital |
ClinicalTrials.gov Identifier: | NCT03209219 |
Other Study ID Numbers: |
Z171100001017217 |
First Posted: | July 6, 2017 Key Record Dates |
Last Update Posted: | February 23, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | The individual participant data are available from the investigator upon reasonable request. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
effectiveness, safety |
Behcet Syndrome Uveitis Uveal Diseases Eye Diseases Mouth Diseases Stomatognathic Diseases Uveitis, Anterior Panuveitis Vasculitis Vascular Diseases Cardiovascular Diseases Hereditary Autoinflammatory Diseases Genetic Diseases, Inborn Skin Diseases, Genetic Skin Diseases |
Skin Diseases, Vascular Interferons Interferon-alpha Interferon alpha-2 Cyclosporine Cyclosporins Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents |