Efficacy and Tolerance of Baricitinib, a JAK Inhibitor, in the Treatment of Refractory Non-infectious Non-anterior Uveitis

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Rouen

About this trial

The aim of the study is to evaluate the efficacy of Baricitinib, a JAK1 and 2 inhibitor, in the management of non-infectious non-anterior uveitis refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab) after 6 months of treatment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with diagnosis of non-anterior non-infectious uveitis, refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab)

Need to stop biotherapy (anti-TNF alpha or tocilizumab) and conventional immunosuppressive drugs (mycofenolate mofetil, methotrexate, azathioprine, cyclosporine, interferon alpha 2a) for at least 10 days prior to the inclusion date

Disqualifiers

1. Isolated anterior uveitis. 2. Infectious uveitis. 3. Severe uveitis threatening the visual prognosis and requiring emergency treatment with intravenous corticosteroids.

Trial design

Design model

Single group

Treatments tested in this trial

  • Baricitinib 4 MG

    Drug

    4 mg per day for 6 months (For patients with creatinine clearance between 30 and 60 mL/min at baseline or during the study, the dosage of baricitinib will be 2 mg daily)

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Patient treated with baricitinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with complete remission

Time frame
6 months

Secondary outcomes

1

Number of patients with complete remission

Time frame
1 month
2

Number of patients with complete remission

Time frame
3 months
3

Number of serious events

Time frame
6 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: