Authorised Phase III and phase IV (Integrated) recently active non-infectious intermediate, posterior, and pan-uveitis

“Randomized controlled multicenter study comparing efficacy and safety of adalimumab to that of mycophenolate mofetil in steroid dependent non-infectious uveitis” - FOCUS

EU CTIS ID: 2023-505112-38-00

What this study is testing

The objective is to compare the efficacy of adalimumab (80mg at day 0, then 40mg/14 days from W1 to W35 subcutaneously) with that of standard of care (mycophenolate mofetil [2g/day orally] for 36 weeks) in recently active non-infectious intermediate, posterior uveitis, and pan-uveitis with steroid dependency.

Phase III and phase IV (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

The eligibility criteria will be checked at the screening visit (which takes place four weeks maximum prior to inclusion visit) and at the inclusion/randomization visit. Adult patients meeting the following criteria may be included in the study: 1. Provide written, informed consent prior to the performance of any study specific procedures
2. ≥18 years of age
3. Diagnosis of non-infectious intermediate, posterior-, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (Standardization of Uveitis Nomenclature [SUN] criteria) of intermediate, posterior, or pan- uveitis confirmed by documented medical history
4. Recent activity of NIU 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) Active chorioretinal or retinal vascular lesion b) Presence of macular edema by optical coherence. c) ≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria) d) ≥ 2+ vitreous haze (National Eye Institute [NEI]/SUN criteria)
5. Chest X-ray or CT-scanner results within 12 weeks prior to inclusion with no evidence of active Tuberculosis, active infection, or malignancy
6. A potential subject with a positive interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test) obtained within 12 weeks prior to inclusion is eligible if: a. Her/his chest X-ray does not show evidence suggestive of active TB disease b. And there are no clinical signs and symptoms of pulmonary and/or extra-pulmonary TB disease. c. And these subjects with a latent TB infection who have not already received a prophylactic TB treatment must agree in advance to complete such a treatment course.

You likely can't join if

Subjects will not be included in the study if they meet any of the following criteria: 1. Infectious uveitis, masquerade syndromes (idiopathic uveitis is permitted)
10. Laboratory values assessed during inclusion: • Hemoglobin < 8g/dL • WBC < 2.0 x 103/mm3 • Platelet count < 80 x 103/mm3 • Glomerular filtration rates (GFR) <30ml/min. • Transaminases > 3 times upper normal value
11. Use of the following systemic treatments during the specified periods: • Treatment with any systemic alkylating agents within 12 months prior to inclusion (e.g., cyclophosphamide, chlorambucil) • Any live (attenuated) vaccine within 4 weeks prior to inclusion.
12. Stage III and IV New York Heart Association (NYHA) cardiac insufficiency
13. Pregnancy or breastfeeding
14. Under legal protection

See the full eligibility criteria

Who can join

The eligibility criteria will be checked at the screening visit (which takes place four weeks maximum prior to inclusion visit) and at the inclusion/randomization visit. Adult patients meeting the following criteria may be included in the study: 1. Provide written, informed consent prior to the performance of any study specific procedures
2. ≥18 years of age
3. Diagnosis of non-infectious intermediate, posterior-, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (Standardization of Uveitis Nomenclature [SUN] criteria) of intermediate, posterior, or pan- uveitis confirmed by documented medical history
4. Recent activity of NIU 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) Active chorioretinal or retinal vascular lesion b) Presence of macular edema by optical coherence. c) ≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria) d) ≥ 2+ vitreous haze (National Eye Institute [NEI]/SUN criteria)
5. Chest X-ray or CT-scanner results within 12 weeks prior to inclusion with no evidence of active Tuberculosis, active infection, or malignancy
6. A potential subject with a positive interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test) obtained within 12 weeks prior to inclusion is eligible if: a. Her/his chest X-ray does not show evidence suggestive of active TB disease b. And there are no clinical signs and symptoms of pulmonary and/or extra-pulmonary TB disease. c. And these subjects with a latent TB infection who have not already received a prophylactic TB treatment must agree in advance to complete such a treatment course.
7. For female subjects of child-bearing potential: a negative pregnancy test at inclusion
8. For subjects with reproductive potential, a willingness to use contraceptive 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 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 CTFG recommendations). Such methods include: For Female subjects : a. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1: ▪ oral ▪ intravaginal ▪ transdermal b. progestogen-only hormonal contraception associated with inhibition of ovulation: ▪ oral ▪ injectable ▪ implantable c. intrauterine device (IUD) d. intrauterine hormone-releasing system (IUS) e. bilateral tubal occlusion f. vasectomised partner g. sexual abstinence (In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject). For male subjects : a. use of condoms b. vasectomy (with documentation of azoospermia) c. sexual abstinence
9. Affiliated to a social security system

What rules you out

Subjects will not be included in the study if they meet any of the following criteria: 1. Infectious uveitis, masquerade syndromes (idiopathic uveitis is permitted)
10. Laboratory values assessed during inclusion: • Hemoglobin < 8g/dL • WBC < 2.0 x 103/mm3 • Platelet count < 80 x 103/mm3 • Glomerular filtration rates (GFR) <30ml/min. • Transaminases > 3 times upper normal value
11. Use of the following systemic treatments during the specified periods: • Treatment with any systemic alkylating agents within 12 months prior to inclusion (e.g., cyclophosphamide, chlorambucil) • Any live (attenuated) vaccine within 4 weeks prior to inclusion.
12. Stage III and IV New York Heart Association (NYHA) cardiac insufficiency
13. Pregnancy or breastfeeding
14. Under legal protection
15. Participation in another interventional study involving human participants or in the exclusion period at the end of a previous study involving human participants, if applicable
2. Isolated anterior uveitis
3. Monophtalmic patient
4. Active tuberculosis
5. Positive HIV serology or HCV HBs Ag test
6. History of malignancy within 5 years prior to Inclusion other than carcinoma in situ of the cervix, non-metastatic squamous or basal cell carcinoma of the skin.
7. History of severe allergic or anaphylactic reactions to monoclonal antibodies, mycophenolate mofetil, rifampicin, isoniazid or fluorescein
8. Infection requiring treatment with intravenous antibiotics within 3 weeks prior to inclusion
9. History of multiple sclerosis and/or demyelinating disorder

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.