A Phase 3 interventional study of Adalimumab and Mycophenolate Mofetil in Non Infectious Uveitis, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-02-14.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
756 studies on the registry are indexed under Macular Edema; 65 are open to participants now.
This study's planned enrollment of 120 is above the median of 56 across 584 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Recent activity of Non Infectious Uveitis as defined by the presence of at least 1 of the following parameters in either eye within the 3 months prior to inclusion visit despite >7mg/day of oral prednisone:
A potential subject with a positive interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test) at inclusion is eligible if:
For subjects with , a willingness to use measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study and 3 months and 5 months after stopping therapy for Mycophenolate mofetil (MMF) and adalimumab, respectively, unless sterility is confirmed. The simultaneous use of two complementary methods of contraception is preferable. Methods which may be considered as highly effective methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods (according to Clinical Trial Falicitation Group (CTFG) recommendations). Such methods include:
For Female subjects :
combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1:
progestogen-only hormonal contraception associated with inhibition of ovulation:
For male subjects :
Exclusion Criteria:
Laboratory values assessed during inclusion:
Use of the following systemic treatments during the specified periods:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Adalimumab
Drug: Mycophenolate Mofetil
Adalimumab (80mg at day 0, then 40mg/14 days from W1 to W35 subcutaneously)
2 g/day orally for 36 weeks
Treatment failure rate
Treatment failure is defined by any of the following in at least one eye: * new active, inflammatory chorioretinal or retinal vascular lesions; * worsening of Best Corrected Visual Acuity (BCVA) by\>3 lines; Score from 20/10 (best vision) to 20/2400 (worst vision). * 2- step increase in anterior chamber cell grade and/or in vitreous haze relative to baseline. Anterior chamber cells scored from 0 (None) to 4+ (intense: fibrin or plastic aquerous) and Vitreous haze Scored from 0 (\<1 cell in field) to +4 (\>100 cells in field) * absence of steroid discontinuation between week 13 and week 19 (as per protocol) * or any additional immunosuppressive drug or injectable steroids
Time frame: At week 36
Time to treatment failure
Time frame: Up to week 55
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 4
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 8
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 12
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 16
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 20
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 24
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 30
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 36
Best corrected visual acuity
Snellen score in each eye. Score from 20/10 (best vision) to 20/2400 (worst vision).
Time frame: At week 55
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 4
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 8
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 12
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 16
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 20
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 24
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 30
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 36
Anterior chamber cell grade in each eye
Score from 0 (None) to 4+ (intense: fibrin or plastic aqueous).
Time frame: At week 55
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (\<1 cell in field) to +4 (\>100 cells in field)
Time frame: At week 4
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (\<1 cell in field) to +4 (\>100 cells in field)
Time frame: At week 8
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (\<1 cell in field) to +4 (\>100 cells in field)
Time frame: At week 12
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (\<1 cell in field) to +4 (\>100 cells in field)
Time frame: At week 16
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (\<1 cell in field) to +4 (\>100 cells in field)
Time frame: At week 20
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (\<1 cell in field) to +4 (\>100 cells in field)
Time frame: At week 24
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (\<1 cell in field) to +4 (\>100 cells in field)
Time frame: At week 30
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (\<1 cell in field) to +4 (\>100 cells in field)
Time frame: At week 36
Vitreous haze grade in each eye.
Nussenblatt score, Score from 0 (\<1 cell in field) to +4 (\>100 cells in field)
Time frame: At week 55
Central retinal thickness in each eye from baseline
Time frame: At week 4
Central retinal thickness in each eye from baseline
Time frame: At week 8
Central retinal thickness in each eye from baseline
Time frame: At week 12
Central retinal thickness in each eye from baseline
Time frame: At week 16
Central retinal thickness in each eye from baseline
Time frame: At week 20
Central retinal thickness in each eye from baseline
Time frame: At week 24
Central retinal thickness in each eye from baseline
Time frame: At week 30
Central retinal thickness in each eye from baseline
Time frame: At week 36
Central retinal thickness in each eye from baseline
Time frame: At week 55
Proportion of patients with central macular thickness< 300 microns
Time frame: At week 4
Proportion of patients with central macular thickness< 300 microns
Time frame: At week 8
Proportion of patients with central macular thickness< 300 microns
Time frame: At week 12
Proportion of patients with central macular thickness< 300 microns
Time frame: At week 16
Proportion of patients with central macular thickness< 300 microns
Time frame: At week 20
Proportion of patients with central macular thickness< 300 microns
Time frame: At week 24
Proportion of patients with central macular thickness< 300 microns
Time frame: At week 30
Proportion of patients with central macular thickness< 300 microns
Time frame: At week 36
Proportion of patients with central macular thickness< 300 microns
Time frame: At week 55
Time to optical coherence tomographic (OCT) evidence of macular edema in at least one eye
Time frame: Up to week 55
National Eye Institute Visual Functioning Questionaire-25 (VFQ-25) composite score
Note after responses converted: 100=Best, 0=Worst possible score
Time frame: At week 12
National Eye Institute Visual Functioning Questionaire-25 (VFQ-25) composite score
Note after responses converted: 100=Best, 0=Worst possible score
Time frame: At week 24
National Eye Institute Visual Functioning Questionaire-25 (VFQ-25) composite score
Note after responses converted: 100=Best, 0=Worst possible score
Time frame: At week 36
Measures of corticosteroid sparing
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
Cumulative incidence of relapse
Time frame: Up to week 55
Number of relapses
Time frame: Up to week 55
Number of clinical manifestations of underlying disease
Depending on the underlying disease
Time frame: Up to week 55
Frequency and severity of adverse events
Time frame: Up to week 55
Treatment discontinuation
Time frame: Up to week 55
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Mar 2024; primary completion for Jun 2027, 39 months later.
Of 65 phase 3 interventional studies under Macular Edema, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 38. This study's planned 39 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adalimumab
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