Monoclonal Antibodies

Adalimumab (ADA) for Uveitis

Q: Are there any unfilled slots in this clinical trial?

The listed clinical trial on clinicaltrials.gov is searching for participants. The posting dates for this study were September 17th, 2019 and June 16th, 2022 respectively.

Q: What do we know about CON from other previous clinical trials?

At the moment, 513 clinical studies are underway which focus on Conventional immunosuppression (CON). Out of these CON trials, 112 have progressed to Phase 3. Most investigations into Conventional immunosuppression (CON) originate from Philadelphia, but there are 11,025 research centres spread out across the globe looking into this topic.

Q: Where are the trial sites for this experiment?

University of California, San Francisco in San Francisco, California, Tennessee Retina in Nashville, Tennessee, and University of Iowa in Iowa City, Iowa are a few example locations where this trial is taking place. In total, there are 21 sites running this study.

Q: What is the mortality rate associated with CON treatment?

There is some efficacy data and multiple rounds of safety data available for Conventional immunosuppression (CON), so it received a score of 3.

Q: What is the standard treatment that Conventional immunosuppression (CON) is used for?

Ocular <a href="https://www.withpower.com/clinical-tri%5Bals%5D(https://www.withpower.com/clinical-trials/als)/rosacea">rosacea</a> is most often treated with immunosuppressive drugs, which are also sometimes used to manage <a href="https://www.withpower.com/clinical-trials/transplant">transplant</a> patients, those with <a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>, and people suffering from dermatitis or atopic conditions.

Q: How many people are involved in the research project?

The clinicaltrials.gov website has the latest information on this study, which is currently looking for 222 participants at 21 sites. The trial was first posted on September 17th, 2019 and was last updated on June 16th, 2020.

Emory University, Atlanta, GA

Conventional immunosuppression (CON) +1 morePhase 3RecruitingResearch 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

Active or recently active (≤ 60 days) non-infectious intermediate, posterior, or panuveitis

If posterior segment disease is present, ability to assess activity in at least one eye with uveitis

Must not have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up12 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Approved for 30 Other Conditions

Study Summary

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

Eligibility Criteria

Inclusion Criteria

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

Select...

You have had or currently have inflammation in the middle or back part of your eye that is not caused by an infection, and it has been less than 60 days since it was active.

Select...

If you have eye inflammation at the back of your eye, you must be able to have at least one eye examined to evaluate its activity.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Pivotal Trial

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

Approved for 30 Other Conditions

This treatment demonstrated efficacy for 30 other conditions.

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 / 2Eligibility criteria met

Find a site

Who is running the clinical trial?

JHSPH Center for Clinical TrialsLead Sponsor

10 Previous Clinical Trials

3,165 Total Patients Enrolled

3 Trials studying Uveitis

641 Patients Enrolled for Uveitis

Douglas A Jabs, MD MBAStudy Chair

CCTand Evidence Synthesis, JHU, Bloomberg School of Public Health

Media Library

Adalimumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03828019 — Phase 3

Uveitis Research Study Groups: Adalimumab (ADA), Conventional immunosuppression (CON)

Uveitis Clinical Trial 2023: Adalimumab Highlights & Side Effects. Trial Name: NCT03828019 — Phase 3

Adalimumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03828019 — Phase 3

Uveitis Patient Testimony for trial: Trial Name: NCT03828019 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots in this clinical trial?

"The listed clinical trial on clinicaltrials.gov is searching for participants. The posting dates for this study were September 17th, 2019 and June 16th, 2022 respectively."

Answered by AI

What do we know about CON from other previous clinical trials?

"At the moment, 513 clinical studies are underway which focus on Conventional immunosuppression (CON). Out of these CON trials, 112 have progressed to Phase 3. Most investigations into Conventional immunosuppression (CON) originate from Philadelphia, but there are 11,025 research centres spread out across the globe looking into this topic."

Answered by AI

Where are the trial sites for this experiment?

"University of California, San Francisco in San Francisco, California, Tennessee Retina in Nashville, Tennessee, and University of Iowa in Iowa City, Iowa are a few example locations where this trial is taking place. In total, there are 21 sites running this study."

Answered by AI

What is the mortality rate associated with CON treatment?

"There is some efficacy data and multiple rounds of safety data available for Conventional immunosuppression (CON), so it received a score of 3."

Answered by AI

What is the standard treatment that Conventional immunosuppression (CON) is used for?

"Ocular rosacea is most often treated with immunosuppressive drugs, which are also sometimes used to manage transplant patients, those with small cell lung cancer, and people suffering from dermatitis or atopic conditions."

Answered by AI

How many people are involved in the research project?

"The clinicaltrials.gov website has the latest information on this study, which is currently looking for 222 participants at 21 sites. The trial was first posted on September 17th, 2019 and was last updated on June 16th, 2020."

Answered by AI