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Monoclonal Antibodies

Adalimumab vs. Conventional Immunosuppression for Uveitis (ADVISE Trial)

Phase 3

Waitlist Available

Research Sponsored by JHSPH Center for Clinical Trials

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient able and willing to self-administer subcutaneous injections or have a qualified person available to administer subcutaneous injections

Weight 30 kg (66 lbs) or greater

Must not have

Current treatment with more than one immunosuppressive drug, not including oral corticosteroids

Current treatment with an alkylating agent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether a new drug, adalimumab, is better than existing treatments for a chronic, potentially blinding disease.

Who is the study for?

This trial is for individuals aged 13 or older, weighing at least 30 kg, with active non-infectious uveitis requiring corticosteroids. Participants must be able to self-administer injections or have someone who can do it for them and not have any medical issues that would interfere with the study. Pregnant women, those with certain infections like tuberculosis or hepatitis B/C, people on specific immunosuppressants, and anyone unwilling to use birth control are excluded.

What is being tested?

The ADVISE Trial is testing whether adalimumab (ADA), a monoclonal antibody approved by the FDA for uveitis treatment, is more effective than conventional small molecule immunosuppressive drugs (CON) in reducing reliance on corticosteroids for treating non-infectious intermediate, posterior, and panuveitides.

What are the potential side effects?

Adalimumab may cause injection site reactions, increased risk of infections due to immune system suppression including tuberculosis reactivation in latent cases; allergic reactions; heart failure exacerbation; liver enzyme elevations; blood disorders such as low white cell count or platelets; demyelinating disease activation like multiple sclerosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can give myself injections or have someone who can.

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I weigh at least 66 lbs (30 kg).

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I need to start or add an immunosuppressive medication.

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I am taking more than 7.5 mg/day of prednisone for my uveitis.

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I am 13 years old or older.

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My eye inflammation is under control with medication over 7.5 mg/day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking more than one drug to suppress my immune system, not counting oral steroids.

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I am currently being treated with a type of chemotherapy.

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I have an active hepatitis B or C infection that hasn't been treated.

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I do not have active or untreated latent tuberculosis.

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I have an immune system disorder that makes certain treatments unsafe for me.

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I have severe heart failure.

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I have been diagnosed with Behçet's disease.

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I currently have cancer.

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I have not received a live vaccine in the last 30 days.

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My MRI shows signs of demyelinating disease, and I have uveitis without systemic disease.

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I have multiple sclerosis or a similar condition.

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I have a severe infection that is not under control.

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My condition requires treatment with steroids or immunosuppressants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Corticosteroid-sparing treatment success within the first 6 months after randomization

Secondary study objectives

Best corrected visual acuity

Corticosteroid-sparing treatment success within the first 12 months after randomization

Generic health-related quality of life

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Adalimumab (ADA)Active Control1 Intervention

Adalimumab administered by subcutaneous injection at dosage and frequency specified below; total duration of treatment is 12 months. Adults (≥ 18 years of age) and adolescents ≥30 kg: 80 mg as initial dose; one week later by 40 mg then 40 mg every two weeks. Adolescents \<30 kg: 40 mg as initial dose; one week later 20 mg then 20 mg every 2 weeks.

Group II: Conventional immunosuppression (CON)Active Control1 Intervention

Conventional immunosuppressive agent selected by study ophthalmologist at dose and frequency specified below;12 month treatment duration. Azathioprine: initially 2 mg/kg/day; max dose 200 mg/day. Methotrexate initially 15mg/wk; max dose 25 mg/wk. Mycophenolate initially 1 gm BID; max dose1.5 gm BID. Cyclosporine (Sandimmune - dose 2.5 mg/kg BID and Neoral dose 2 mg/kg BID. Tacrolimus initially 1 mg BID; max dose 3 mg BID.

0 / 19Eligibility criteria met