Behçet DiseasePhase 3NCT03209219
Interferon α2a Versus Cyclosporine for Refractory Behçet's Disease Uveitis
A Phase 3 study testing Interferon Alfa-2A and Cyclosporine Pill in people with Behçet Disease and Uveitis, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Behçet Disease, Uveitis
- What is being tested?
- Interferon Alfa-2A and Cyclosporine Pill
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2017to 31 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Prospective Comparative Study of Interferon α2a and Cyclosporine in Patients With Refractory Behçet's Disease Uveitis
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.
Read the 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.
- Conditions
- Behçet Disease, Uveitis
- Being tested
- Interferon Alfa-2A, Cyclosporine Pill
- Keywords
- effectiveness, safety
- Medical subject headings
- Behcet Syndrome, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon Alfa-2ADrug
3×10^6 IU， subcutaneous or intramuscular injection, qd for × 4 weeks, and qod thereafter
Cyclosporine PillDrug
100mg， oral, bid
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Interferon Alfa-2A |
| Cyclosporine | Active comparator | Patients are treated with oral CsA 100mg twice daily. Receives: Drug: Cyclosporine Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Percentage of participants who achieve complete remission or partial remission
Measured: Within the 12-month follow-up period
Complete remission rate
Percentage of participants who achieve complete remission without relapse of posterior or pan-uveitis
Measured: Within the 12-month follow-up period
Tolerance rate
Percentage of participants who adhere to the treatment without severe side effects
Measured: Within the 12-month follow-up period
Secondary outcomes (8)
Time to reach complete remission
The time from the therapy initiation to a complete absence of ocular inflammation for complete responders
Measured: Within the 12-month follow-up period
Duration of relapse-free
The duration between the therapy initiation to the relapse for partial responders and nonresponders
Measured: within the 12-month follow-up period
BCVA
Changes of best-corrected visual acuity
Measured: Within the 12-month follow-up period
BOS24 score
Score of ocular inflammation using the Behcet disease ocular attack score 24 (BOS24)
Measured: Within the 12-month follow-up period
Glucocorticoid-sparing effect
Changes of corticosteroid dosage
Measured: Within the 12-month follow-up period
Incidence of adverse effects
Incidence of adverse effects
Measured: Within the 12-month follow-up period
Incidence of significant abnormal changes in vital signs or laboratory test results
Incidence of significant abnormal changes in vital signs or laboratory test results
Measured: Within the 12-month follow-up period
Adverse effects profile
Types of drug adverse effects
Measured: Within the 12-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start30 Jun 2017
- Primary completion31 Aug 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behçet DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meifen Zhang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209219
- Sponsor's protocol ID
- Z171100001017217
- Status last verified
- Feb 2021
- First submitted
- 4 Jul 2017
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data are available from the investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Comparative Study of Interferon α2a and Cyclosporine in Patients With Refractory Behçet's Disease Uveitis
- ClinicalTrials.gov ID
- NCT03209219
- Acronym / sponsor ID
- Z171100001017217
- Conditions
- Behçet Disease, Uveitis
- Keywords
- effectiveness, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferon Alpha 2A | Experimental | Drug: Interferon Alfa-2APatients 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. |
| Cyclosporine | Active comparator | Drug: Cyclosporine PillPatients are treated with oral CsA 100mg twice daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (23 listed)
- Previous treatment with interferon-α;
- Pregnancy, breast feeding women;
- Malignancy;
- Renal impairment (creatinine > 1.5 mg/dl);
- Uncontrolled hypertension or diabetes;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon Alfa-2A3×10^6 IU， subcutaneous or intramuscular injection, qd for × 4 weeks, and qod thereafter | Drug | Interferon Alpha 2A |
| Cyclosporine Pill100mg， oral, bid | Drug | Cyclosporine |
Primary outcome
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
8 secondary outcomes
Time to reach complete remission
Time frame: Within the 12-month follow-up period
Duration of relapse-free
Time frame: within the 12-month follow-up period
BCVA
Time frame: Within the 12-month follow-up period
BOS24 score
Time frame: Within the 12-month follow-up period
Glucocorticoid-sparing effect
Time frame: Within the 12-month follow-up period
Incidence of adverse effects
Time frame: Within the 12-month follow-up period
Incidence of significant abnormal changes in vital signs or laboratory test results
Time frame: Within the 12-month follow-up period
Adverse effects profile
Time frame: Within the 12-month follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No. The individual participant data are available from the investigator upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interferon Alfa-2A and Cyclosporine Pill in people with Behçet Disease and Uveitis, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Within the 12-month follow-up period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.