CompletedPhase 3

Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis

China28 participantsStarted 2017-06-30

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared Interferon α2a directly against Cyclosporine for Behçet's uveitis that hasn't responded to other treatments — can you tell me what the results showed in terms of which treatment had a better response or remission rate, and how that might apply to my specific situation?
2Since this was a Phase 3 trial that has already completed, does the evidence from it change your recommendation about whether Interferon α2a or Cyclosporine would be the better option for managing my uveitis?
3The trial specifically measured 'tolerance rate' as a primary outcome — what kinds of side effects or tolerability issues were being tracked for each drug, and which one tends to be easier for patients to stay on long-term?
4My uveitis has been described as refractory, meaning it hasn't responded well to prior treatment — based on what this trial found, is either of these two drugs a stronger candidate for someone in my position, or should we consider other options first?
5Since this study was conducted in Behçet's disease patients specifically, how does the evidence from it compare to what's known about using these same drugs for other types of uveitis, and does that distinction matter for how you'd interpret the results for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response rate

Timeframe: Within the 12-month follow-up period

Complete remission rate

Timeframe: Within the 12-month follow-up period

Tolerance rate

Timeframe: Within the 12-month follow-up period

Trial details

NCT IDNCT03209219

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08-31

View on ClinicalTrials.gov More Behçet Disease trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.