Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis

NCT03209219 | Completed Phase 3

• 1 other identifier: Z171100001017217
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Behçet Disease; Uveitis

Keywords

effectiveness, safety

Outcome Measures

Primary Outcomes (3)

• Response rate

  Percentage of participants who achieve complete remission or partial remission

  Within the 12-month follow-up period

• Complete remission rate

  Percentage of participants who achieve complete remission without relapse of posterior or pan-uveitis

  Within the 12-month follow-up period

• Tolerance rate

  Percentage of participants who adhere to the treatment without severe side effects

  Within the 12-month follow-up period

Secondary Outcomes (8)

• Time to reach complete remission

  Within the 12-month follow-up period

• Duration of relapse-free

  within the 12-month follow-up period

• BCVA

  Within the 12-month follow-up period

• BOS24 score

  Within the 12-month follow-up period

• Glucocorticoid-sparing effect

  Within the 12-month follow-up period

Study Arms (2)

Interferon Alpha 2A

EXPERIMENTAL

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.

Drug: Interferon Alfa-2A

Cyclosporine

ACTIVE COMPARATOR

Patients are treated with oral CsA 100mg twice daily.

Drug: Cyclosporine Pill

Interventions

Interferon Alfa-2A DRUG

3×10\^6 IU， subcutaneous or intramuscular injection, qd for × 4 weeks, and qod thereafter

Interferon Alpha 2A

Cyclosporine Pill DRUG

100mg， oral, bid

Cyclosporine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Behcet Syndrome; Uveitis

Interventions

Interferon alpha-2; Cyclosporine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 6, 2017
• Study Start: June 30, 2017
• Primary Completion: August 31, 2020
• Study Completion: January 31, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)