UveitisPhase 2/3ADJUVITENCT01385826
Effect of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic Arthritis
A Phase 2/3 study testing Anti-tumor necrosis factor alpha monoclonal antibody in people with Uveitis and Juvenile Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The investigators propose to study the efficacy of adalimumab versus placebo (double-blind randomization on inclusion into 2 equal groups) on reduction of ocular inflammation quantified by laser flare photometry after two months of treatment in patients with active uveitis despite well conducted treatment with steroid… Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Uveitis, Juvenile Arthritis
- What is being tested?
- Anti-tumor necrosis factor alpha monoclonal antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2011to 27 Aug 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Active uveitis associated with juvenile idiopathic arthritis, with the exclusion of systemic JIA, juvenile-onset rheumatoid arthritis, and enthesitis-related JIA
- Uveitis resistant to well conducted topical steroid therapy comprising either dexamethasone or rimexolone at a dose adapted to the patient's situation as validated by one of the investigating ophthalmologists.
- Failure of systemic treatment with methotrexate at a dose of 0.3 to 0.6 mg.kg (without exceeding 25 mg) once a week for at least 3 months (except in the case of methotrexate intolerance).
- Patient who can be evaluated by laser flare photometry.
- Patient at least 4 years old on initiation of trial medication and weighing a minimum of 15 kg
- Signed informed consent both parents and/or patient's agreement
- Patient has a social security or similar
Who cannot join
- Systemic JIA, juvenile-onset rheumatoid arthritis, enthesitis-related JIA (with a risk of red eye uveitis).
- History of treatment with anti-TNF alpha monoclonal antibody (either adalimumab or infliximab).
- Any contraindication to administration of immunosuppressive therapy (immune deficit, opportunistic infection, other severe chronic disease)
- History of cancer or lymphoproliferative disease other than successfully and completely resected squamous cell or basal cell skin cancer,
- Any uncontrolled disease: unstable diabetes with documented history of recurrent infections, unstable ischaemic heart disease, moderate to severe heart failure (NYHA stage III/IV), recent stroke and any other disease or condition inducing, in the investigator's opinion, a risk for the patient related to his/her participation in the trial,
- Positive hepatitis B or C serology indicating active infection,
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- History of positive HIV serology,
- Persistent infection or severe infections requiring hospitalisation or IV antibiotic therapy during the 30 days prior to inclusion in the trial or oral antibiotic therapy during the 14 days prior to inclusion in the trial,
- History of clinically significant alcohol or other substance abuse during the previous year,
- Previous diagnosis or signs of demyelinating disease of the central nervous system,
- History of active tuberculosis, histoplasmosis or listeriosis,
- Signs of latent tuberculosis (based on a history of nontreated contamination, or an opacity greater than 1 cm on chest x-ray, or a positive intradermal reaction to 5 IU of tuberculin ≥ 5 mm).
- Negative urine pregnancy test in girls with childbearing potential
- Chronic rupture of the blood-aqueous barrier with marked flare on the initial examination but not modified by one month of anti-inflammatory therapy.
- Impossibility to monitor flare:
- Children < 4 years
- False flare due to the presence of giant cells on the surface of an artificial lens or in an aphakic child.
- Children presenting complications such as refractory glaucoma or cataract rapidly requiring surgery.
- Phthisis bulbi with hypotonia and atrophy of the ciliary body.
- Any other situation raising problems for maintenance of stable doses of steroids and immunosuppressive drugs during the period between 4 weeks before D0 and the M2 evaluation. Authorized immunosuppressive therapies that must be maintained at stable dose are steroid eye drops, systemic steroid therapy and once weekly oral or subcutaneous MTX at a dose of 0.3 to 0.6 mg (without exceeding 25 mg).
- Any ophthalmologic contraindication
- If female and childbearing potential should have an appropriate contraceptive method during all study period and 5 months after last adalimumab dose. Abstinence with no oral contraception can be considered.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic Arthritis: Randomized Double-blind Placebo-controlled Trial
The investigators propose to study the efficacy of adalimumab versus placebo (double-blind randomization on inclusion into 2 equal groups) on reduction of ocular inflammation quantified by laser flare photometry after two months of treatment in patients with active uveitis despite well conducted treatment with steroid eye drops and MTX. The primary objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus the placebo arm. Will be considered as responding patients those in whom the evaluated eye, 2 months after inclusion, presents at least 30% reduction of inflammation on laser flare photometry and improvement or a stable appearance on slit lamp examination. After the second month, all patients wishing to continue the trial and presenting a satisfactory clinical state will be treated with adalimumab for a total of one year after inclusion to descriptively evaluate the efficacy and safety of treatment over 10 to 12 months.
Read the detailed description
20% of patients with juvenile idiopathic arthritis (JIA) develop usually bilateral, chronic anterior uveitis, dependent on steroid eye drops and sometimes systemic steroid therapy, with a risk of complications such as cataract, band keratopathy and glaucoma, usually responsible for loss of vision. No maintenance treatment has been demonstrated to be effective. Methotrexate (MTX), the maintenance treatment most commonly used in JIA, could have a beneficial effect, but this effect is not sufficient to stop progression of uveitis in most patients. Our preliminary experience and that of other teams based on small series of patients is in favour of the efficacy of anti-Tumour Necrosis Factor alpha (TNFalpha) monoclonal antibodies (Ab) in JIA-associated uveitis. An international multicentre randomized trial of a humanized monoclonal antibody, adalimumab, in JIA has demonstrated its efficacy on joint lesions and its good safety as monotherapy or in combination with methotrexate. However, children with active uveitis were excluded from this trial.
The investigators propose a French multicentre, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of adalimumab in JIA-associated uveitis in patients over the age of 4 years. These patients must have active uveitis (Laser flare-cell meter score of at least 30 photons/ms) despite topical steroid therapy, with intolerance or failure to at least 3 months of MTX therapy. The dose of adalimumab will be 40 mg eow for children age 13 and over and for children younger than 13 adalimumab 24 mg per m2 BSA (up to a maximum total body dose of 40 mg). The activity of uveitis will be evaluated by laser flare photometry, a recently validated technique for follow-up of the efficacy of treatments of anterior uveitis. Seven hospital ophthalmology departments in France are equipped with laser flare photometry and have a sufficient experience to participate in this trial (Paris-Pitie-Salpetriere, Paris-Cochin, Nantes, Lille, Grenoble, Bordeaux and Lyon). Several teams of paediatric rheumatologists and hospital rheumatologists working with these ophthalmology departments will also be able to include patients. The primary endpoint is an at least 30% reduction of ocular inflammation after 2 months of treatment, quantified by laser flare photometry, considering the more severely affected eye in the case of bilateral uveitis. Based on the hypothesis of a response rate of at least 50% with adalimumab versus a maximum of 10% with placebo, comparison of two groups of 19 patients would be sufficient to conclude on a significant difference for a two-sided alpha risk of p=0.05 and a power of 80%. The investigators therefore plan to include 40 patients with randomization to two equal groups, one receiving 4 subcutaneous injections of adalimumab and the other receiving 4 injections of placebo on D0, D14, D28, and D42 with assessment of the primary endpoint at M2. The planned duration of inclusion is 2 years with a total duration of the trial of 3 years. From visit M2 onwards, all patients will be treated by adalimumab injections every 2 weeks and will be followed for 1 year of treatment. Clinical, laboratory and ophthalmological evaluation including laser flare photometry and conventional slit lamp examination will be performed at each visit (pre-inclusion, D0, D14, M1, M2, M3, M4, M5, M6, M9 and M12). Deterioration of ocular inflammation during the first 2 months will justify decoding for the patient concerned who will be considered to be a treatment failure.
A study will be conducted in parallel: gene expression profile studies on whole blood by a team experienced in the study of JIA and other inflammatory diseases (Dr Pascual, Dallas, USA).
- Conditions
- Uveitis, Juvenile Arthritis
- Being tested
- Anti-tumor necrosis factor alpha monoclonal antibody, placebo
- Keywords
- Uveitis, Juvenile arthritis, Anti-tumor necrosis factor alpha monoclonal antibody, treatment
- Medical subject headings
- Uveitis, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-tumor necrosis factor alpha monoclonal antibodyDrug
The dose of adalimumab will be 40 mg for children age 13 and over and for children younger than 13 adalimumab 24 mg per m2 BSA (up to a maximum total body dose of 40 mg).
placeboDrug
Patients will receive 4 injections of placebo on D0, D14, D28, and D42 with assessment of the primary endpoint at M2
| Study group | Role | What they receive |
|---|---|---|
| adalimumab | Experimental | Anti-tumor necrosis factor alpha monoclonal antibody Receives: Drug: Anti-tumor necrosis factor alpha monoclonal antibody |
| placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that a higher proportion of subjects will have an improvement of uveitis on adalimumab versus placebo after 2 months relative to baseline
The primary objective is to demonstrate the efficacy of 2 months of treatment with adalimumab versus placebo on reduction of ocular inflammation in JIA-associated uveitis.
By defining response to treatment as a reduction of at least 30% of ocular inflammation quantified by laser flare photometry in the initially more severely inflamed eye without deterioration of cell count or flare protein on slit lamp examination, we formulate the hypothesis that at least 50% of patients treated with adalimumab for 2 months will respond to treatment versus a maximum 10% of patients on placebo.
Measured: Final visit could occur at any point up to 78 weeks
Secondary outcomes (6)
Evaluation of adverse events
To evaluate the safety of treatment at 2 months then at 12 months
Measured: 12 months
Proportion of subjects at each study time point with an improvement of uveitis
To evaluate the response of the treatment on ocular inflammation quantified by slit lamp examination and laser flare photometry at each visit comparatively between the adalimumab arm and the placebo arm during the double-blind period (until M2, as a complement to the laser flare photometry evaluation performed for the primary objective) and then descriptively on adalimumab. Analyses will be performed on the eye evaluated for the primary objective and for the fellow eye in patients with bilateral uveitis.
Measured: 2 months
Eyes with active uveitis
To compare the proportion of eyes with active uveitis on inclusion improved after 2 months between the adalimumab arm and the placebo arm
Measured: 2 months
The efficacy of treatment on juvenile idiopathic arthritis
To evaluate the efficacy of treatment on JIA, particularly the joint lesions at each visit, comparatively between the adalimumab arm and the placebo arm until M2 then descriptively on adalimumab
Measured: 2 months
Decrease topical or systemic steroid therapy
To evaluate the possibility to decrease topical steroid therapy and when applicable systemic steroid therapy between M2 and M12
Measured: 12 months
Transcriptome modifications on whole blood
To evaluate possible transcriptome modifications on whole blood in the context of a collaboration with a team experienced in analysis of cytokine signatures associated with JIA and other inflammatory diseases in children (team directed by V. Pascual in Dallas).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study start29 Jun 2011
- Primary completion4 Nov 2014
- Study completion27 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Pierre Quartier dit Maire, MD, PhD, Principal investigator, hospital Necker Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385826
- Sponsor's protocol ID
- P081210
- Acronym
- ADJUVITE
- Status last verified
- Sep 2025
- First submitted
- 24 May 2011
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Simonini G, Taddio A, Cattalini M, Caputo R, De Libero C, Naviglio S, Bresci C, Lorusso M, Lepore L, Cimaz R. Prevention of flare recurrences in childhood-refractory chronic uveitis: an open-label comparative study of adalimumab versus infliximab. Arthritis Care Res (Hoboken). 2011 Apr;63(4):612-8. doi: 10.1002/acr.20404.
PubMed 21452272Callejas-Rubio JL, Sanchez-Cano D, Serrano JL, Ortego-Centeno N. Adalimumab therapy for refractory uveitis: a pilot study. J Ocul Pharmacol Ther. 2008 Dec;24(6):613-4; author reply 614. doi: 10.1089/jop.2008.0073. No abstract available.
PubMed 19049264Tynjala P, Kotaniemi K, Lindahl P, Latva K, Aalto K, Honkanen V, Lahdenne P. Adalimumab in juvenile idiopathic arthritis-associated chronic anterior uveitis. Rheumatology (Oxford). 2008 Mar;47(3):339-44. doi: 10.1093/rheumatology/kem356. Epub 2008 Jan 31.
PubMed 18238789Biester S, Deuter C, Michels H, Haefner R, Kuemmerle-Deschner J, Doycheva D, Zierhut M. Adalimumab in the therapy of uveitis in childhood. Br J Ophthalmol. 2007 Mar;91(3):319-24. doi: 10.1136/bjo.2006.103721. Epub 2006 Oct 11.
PubMed 17035274Vazquez-Cobian LB, Flynn T, Lehman TJ. Adalimumab therapy for childhood uveitis. J Pediatr. 2006 Oct;149(4):572-5. doi: 10.1016/j.jpeds.2006.04.058.
PubMed 17011337Quartier P, Baptiste A, Despert V, Allain-Launay E, Kone-Paut I, Belot A, Kodjikian L, Monnet D, Weber M, Elie C, Bodaghi B; ADJUVITE Study Group. ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis. Ann Rheum Dis. 2018 Jul;77(7):1003-1011. doi: 10.1136/annrheumdis-2017-212089. Epub 2017 Dec 23.
PubMed 29275333
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic Arthritis: Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01385826
- Acronym / sponsor ID
- ADJUVITE / P081210
- Conditions
- Uveitis, Juvenile Arthritis
- Keywords
- Uveitis, Juvenile arthritis, Anti-tumor necrosis factor alpha monoclonal antibody, treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Abbott, URC-CIC Paris Descartes Necker Cochin
- Study start
- 29 Jun 2011 (actual)
- Primary completion
- 4 Nov 2014 (actual)
- Study completion
- 27 Aug 2015 (actual)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to study the efficacy of adalimumab versus placebo (double-blind randomization on inclusion into 2 equal groups) on reduction of ocular inflammation quantified by laser flare photometry after two months of treatment in patients with active uveitis despite well conducted treatment with steroid eye drops and MTX. The primary objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus the placebo arm. Will be considered as responding patients those in whom the evaluated eye, 2 months after inclusion, presents at least 30% reduction of inflammation on laser flare photometry and improvement or a stable appearance on slit lamp examination. After the second month, all patients wishing to continue the trial and presenting a satisfactory clinical state will be treated with adalimumab for a total of one year after inclusion to descriptively evaluate the efficacy and safety of treatment over 10 to 12 months.
Detailed description
20% of patients with juvenile idiopathic arthritis (JIA) develop usually bilateral, chronic anterior uveitis, dependent on steroid eye drops and sometimes systemic steroid therapy, with a risk of complications such as cataract, band keratopathy and glaucoma, usually responsible for loss of vision. No maintenance treatment has been demonstrated to be effective. Methotrexate (MTX), the maintenance treatment most commonly used in JIA, could have a beneficial effect, but this effect is not sufficient to stop progression of uveitis in most patients. Our preliminary experience and that of other teams based on small series of patients is in favour of the efficacy of anti-Tumour Necrosis Factor alpha (TNFalpha) monoclonal antibodies (Ab) in JIA-associated uveitis. An international multicentre randomized trial of a humanized monoclonal antibody, adalimumab, in JIA has demonstrated its efficacy on joint lesions and its good safety as monotherapy or in combination with methotrexate. However, children with active uveitis were excluded from this trial.
The investigators propose a French multicentre, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of adalimumab in JIA-associated uveitis in patients over the age of 4 years. These patients must have active uveitis (Laser flare-cell meter score of at least 30 photons/ms) despite topical steroid therapy, with intolerance or failure to at least 3 months of MTX therapy. The dose of adalimumab will be 40 mg eow for children age 13 and over and for children younger than 13 adalimumab 24 mg per m2 BSA (up to a maximum total body dose of 40 mg). The activity of uveitis will be evaluated by laser flare photometry, a recently validated technique for follow-up of the efficacy of treatments of anterior uveitis. Seven hospital ophthalmology departments in France are equipped with laser flare photometry and have a sufficient experience to participate in this trial (Paris-Pitie-Salpetriere, Paris-Cochin, Nantes, Lille, Grenoble, Bordeaux and Lyon). Several teams of paediatric rheumatologists and hospital rheumatologists working with these ophthalmology departments will also be able to include patients. The primary endpoint is an at least 30% reduction of ocular inflammation after 2 months of treatment, quantified by laser flare photometry, considering the more severely affected eye in the case of bilateral uveitis. Based on the hypothesis of a response rate of at least 50% with adalimumab versus a maximum of 10% with placebo, comparison of two groups of 19 patients would be sufficient to conclude on a significant difference for a two-sided alpha risk of p=0.05 and a power of 80%. The investigators therefore plan to include 40 patients with randomization to two equal groups, one receiving 4 subcutaneous injections of adalimumab and the other receiving 4 injections of placebo on D0, D14, D28, and D42 with assessment of the primary endpoint at M2. The planned duration of inclusion is 2 years with a total duration of the trial of 3 years. From visit M2 onwards, all patients will be treated by adalimumab injections every 2 weeks and will be followed for 1 year of treatment. Clinical, laboratory and ophthalmological evaluation including laser flare photometry and conventional slit lamp examination will be performed at each visit (pre-inclusion, D0, D14, M1, M2, M3, M4, M5, M6, M9 and M12). Deterioration of ocular inflammation during the first 2 months will justify decoding for the patient concerned who will be considered to be a treatment failure.
A study will be conducted in parallel: gene expression profile studies on whole blood by a team experienced in the study of JIA and other inflammatory diseases (Dr Pascual, Dallas, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adalimumab | Experimental | Drug: Anti-tumor necrosis factor alpha monoclonal antibodyAnti-tumor necrosis factor alpha monoclonal antibody |
| placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Active uveitis associated with juvenile idiopathic arthritis, with the exclusion of systemic JIA, juvenile-onset rheumatoid arthritis, and enthesitis-related JIA
- Uveitis resistant to well conducted topical steroid therapy comprising either dexamethasone or rimexolone at a dose adapted to the patient's situation as validated by one of the investigating ophthalmologists.
- Failure of systemic treatment with methotrexate at a dose of 0.3 to 0.6 mg.kg (without exceeding 25 mg) once a week for at least 3 months (except in the case of methotrexate intolerance).
- Patient who can be evaluated by laser flare photometry.
- Patient at least 4 years old on initiation of trial medication and weighing a minimum of 15 kg
Key exclusion criteria (22 listed)
- Systemic JIA, juvenile-onset rheumatoid arthritis, enthesitis-related JIA (with a risk of red eye uveitis).
- History of treatment with anti-TNF alpha monoclonal antibody (either adalimumab or infliximab).
- Any contraindication to administration of immunosuppressive therapy (immune deficit, opportunistic infection, other severe chronic disease)
- Chronic rupture of the blood-aqueous barrier with marked flare on the initial examination but not modified by one month of anti-inflammatory therapy.
- Impossibility to monitor flare:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-tumor necrosis factor alpha monoclonal antibodyThe dose of adalimumab will be 40 mg for children age 13 and over and for children younger than 13 adalimumab 24 mg per m2 BSA (up to a maximum total body dose of 40 mg). | Drug | adalimumab |
| placeboPatients will receive 4 injections of placebo on D0, D14, D28, and D42 with assessment of the primary endpoint at M2 | Drug | placebo |
Primary outcome
To demonstrate that a higher proportion of subjects will have an improvement of uveitis on adalimumab versus placebo after 2 months relative to baseline
Time frame: Final visit could occur at any point up to 78 weeks
The primary objective is to demonstrate the efficacy of 2 months of treatment with adalimumab versus placebo on reduction of ocular inflammation in JIA-associated uveitis. By defining response to treatment as a reduction of at least 30% of ocular inflammation quantified by laser flare photometry in the initially more severely inflamed eye without deterioration of cell count or flare protein on slit lamp examination, we formulate the hypothesis that at least 50% of patients treated with adalimumab for 2 months will respond to treatment versus a maximum 10% of patients on placebo.
6 secondary outcomes
Evaluation of adverse events
Time frame: 12 months
Proportion of subjects at each study time point with an improvement of uveitis
Time frame: 2 months
Eyes with active uveitis
Time frame: 2 months
The efficacy of treatment on juvenile idiopathic arthritis
Time frame: 2 months
Decrease topical or systemic steroid therapy
Time frame: 12 months
Transcriptome modifications on whole blood
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 21452272Simonini G, Taddio A, Cattalini M, Caputo R, De Libero C, Naviglio S, Bresci C, Lorusso M, Lepore L, Cimaz R. Prevention of flare recurrences in childhood-refractory chronic uveitis: an open-label comparative study of adalimumab versus infliximab. Arthritis Care Res (Hoboken). 2011 Apr;63(4):612-8. doi: 10.1002/acr.20404.
- Background: PubMed 19049264Callejas-Rubio JL, Sanchez-Cano D, Serrano JL, Ortego-Centeno N. Adalimumab therapy for refractory uveitis: a pilot study. J Ocul Pharmacol Ther. 2008 Dec;24(6):613-4; author reply 614. doi: 10.1089/jop.2008.0073. No abstract available.
- Background: PubMed 18238789Tynjala P, Kotaniemi K, Lindahl P, Latva K, Aalto K, Honkanen V, Lahdenne P. Adalimumab in juvenile idiopathic arthritis-associated chronic anterior uveitis. Rheumatology (Oxford). 2008 Mar;47(3):339-44. doi: 10.1093/rheumatology/kem356. Epub 2008 Jan 31.
- Background: PubMed 17035274Biester S, Deuter C, Michels H, Haefner R, Kuemmerle-Deschner J, Doycheva D, Zierhut M. Adalimumab in the therapy of uveitis in childhood. Br J Ophthalmol. 2007 Mar;91(3):319-24. doi: 10.1136/bjo.2006.103721. Epub 2006 Oct 11.
- Background: PubMed 17011337Vazquez-Cobian LB, Flynn T, Lehman TJ. Adalimumab therapy for childhood uveitis. J Pediatr. 2006 Oct;149(4):572-5. doi: 10.1016/j.jpeds.2006.04.058.
- Results publication: PubMed 29275333Quartier P, Baptiste A, Despert V, Allain-Launay E, Kone-Paut I, Belot A, Kodjikian L, Monnet D, Weber M, Elie C, Bodaghi B; ADJUVITE Study Group. ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis. Ann Rheum Dis. 2018 Jul;77(7):1003-1011. doi: 10.1136/annrheumdis-2017-212089. Epub 2017 Dec 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Quartier dit Maire, MD, PhD principal investigator
hospital Necker Enfants Malades
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anti-tumor necrosis factor alpha monoclonal antibody in people with Uveitis and Juvenile Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate that a higher proportion of subjects will have an improvement of uveitis on adalimumab versus placebo after 2 months relative to baseline (time frame: Final visit could occur at any point up to 78 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01385826, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.