Adalimumab
DrugAdalimumab (80mg at day 0, then 40mg/14 days from W1 to W35 subcutaneously)
NCT Number: NCT06258915
FOCUS is the first prospective randomized study comparing standard of care (mycophenolate mofetil) to adalimumab in recently active non infectious uveitis (NIU) with steroid dependency. There is no firm evidence or randomized trials that compared classical immunosuppressive compounds to biological agents; or identified the best treatment in this condition. The burden of NIU has been reduced with the use of immunosuppressive agents and biologics, raising the question of which of these compounds should be preferentially used in recently active NIU with steroid dependency.
Trial opening soon.
Get Notified18 year–100 year
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For Female subjects :
For male subjects :
Exclusion criteria
Adalimumab (80mg at day 0, then 40mg/14 days from W1 to W35 subcutaneously)
2 g/day orally for 36 weeks
Time frame: At week 36
Treatment failure is defined by any of the following in at least one eye:
Time frame: Up to week 55
Time frame: At week 4
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 8
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 12
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 16
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 20
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 24
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 30
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 36
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 55
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 4
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 8
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 12
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 16
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 20
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 24
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 30
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 36
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 55
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 4
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Time frame: At week 8
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Time frame: At week 12
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Time frame: At week 16
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Time frame: At week 20
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Time frame: At week 24
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Time frame: At week 30
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Time frame: At week 36
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Time frame: At week 55
Nussenblatt score, Score from 0 (<1 cell in field) to +4 (>100 cells in field)
Time frame: At week 4
Time frame: At week 8
Time frame: At week 12
Time frame: At week 16
Time frame: At week 20
Time frame: At week 24
Time frame: At week 30
Time frame: At week 36
Time frame: At week 55
Time frame: At week 4
Time frame: At week 8
Time frame: At week 12
Time frame: At week 16
Time frame: At week 20
Time frame: At week 24
Time frame: At week 30
Time frame: At week 36
Time frame: At week 55
Time frame: Up to week 55
Time frame: At week 12
Note after responses converted: 100=Best, 0=Worst possible score
Time frame: At week 24
Note after responses converted: 100=Best, 0=Worst possible score
Time frame: At week 36
Note after responses converted: 100=Best, 0=Worst possible score
Time frame: Up to week 55
Percent meeting targets [<0.1 mg/kg/day prednisone], mean change, mean dose at week 55, and cumulative dose
Time frame: Up to week 55
Time frame: Up to week 55
Time frame: Up to week 55
Depending on the underlying disease
Time frame: Up to week 55
Time frame: Up to week 55
Contact information is provided by the study sponsor or research team.
Bahram BODAGHI, Pr
CONTACT
Jérôme Lambert, Pr
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Randomized Controlled Multicenter Study Comparing Efficacy and Safety of Adalimumab to That of Mycophenolate Mofetil in Steroid Dependent Non-infectious Uveitis
Acronym: FOCUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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