Adalimumab in Uveitis Refractory to Conventional Therapy (ADUR Trial)

Heidelberg University

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Uveitis

Treatments

Drug: Adalimumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00348153

EudraCT: 2006-001732-53

Details and patient eligibility

About

TNF alpha Inhibitors have been very effective in treating rheumatologic diseases as well as uveitis. Adalimumab is the first member of a new class of TNF antibody compounds developed to contain exclusively human sequences. We want to test the efficacy and safety of the TNF alpha Inhibitor Adalimumab in patients with active uveitis despite standard immunosuppressive therapy.

Full description

TNF alpha Inhibitors like Infliximab and Etanercept have been very effective in treating rheumatologic diseases. They have been used to treat severe uveitis by several groups, Suhler and coworkers have published the largest series in 2005. Adalimumab, a recombinant, full-length immunoglobulin, is the first member of a new class of TNF antibody compounds developed to contain exclusively human sequences. The duration of therapeutic efficacy of other TNF antibodies, which contain non-human sequences, may be limited to a greater extent by antibody responses raised in subjects over time. We want to test the efficacy and safety of the TNF alpha Inhibitor Adalimumab in patients with active uveitis despite standard immunosuppressive therapy requiring systemic corticosteroids > 7,5mg prednisolone.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female patients age 18 and older
Subjects must meet the criteria for non-infectious uveitis according to the definition of the SUN working group
Uveitis must have first been diagnosed at least 6 months ago
Persistence of active disease ( > 2 flares within 6 months) or progressive deterioration of vision (< 0,6) within the last 3 months despite immunosuppressive therapy requiring corticosteroids ≥ 7,5 mg prednisone
Women of childbearing potential have to practice a reliable birth control method throughout the study and until five months after the last administration of Adalimumab
Ability to comprehend and willing to give informed consent for participation in the study
Able and willing to self-administer sc injections or assistance of a suitable person to administer sc injections
Negative PPD skin test or serological testing according to official German recommendations for tuberculosis testing AND chest X-ray within the last three month. Treatment of latent TB with INH must be started 4 weeks prior to administration of first dose of study drug.

Exclusion criteria

Participation in another clinical trial and/or observation period of competing trials
Treatment with infliximab within the last 2 months or with etanercept within the last 3 weeks
Patients with only intermediary uveitis or optic neuritis multiple sclerosis
Patients with uveitis caused by infection
Patients with optic atrophy, macular scar, cataract, amblyopia or corneal scars
Patients with recurrent episodes of uveitis, but long intermittent phases of complete remissions without therapy
Patients possibly demanding vitrectomy or cataract surgery within the time of clinical trial
Pregnant and nursing women or women planning a pregnancy within 5 months
Persistent or recurrent infections or severe infections requiring hospitalization with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment
Known opportunistic infection (such as herpes zoster) during the last 2 months
Live vaccination during the last 30 days
History of tuberculosis; histoplasmosis or listeriosis
Known HIV infection, active hepatitis B or C
Comorbidities: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III, IV), active inflammatory bowl disease, recent stroke (within three months), chronic leg ulcer and similar conditions which would put the subject at risk by participation in the trial
Previous diagnosis of signs of central nervous system demyelinating diseases
History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma of the skin or cervical dysplasia, with no recurrence within the last two years
Hemoglobin < 10 g/dl, white blood cell count < 3.0x109/l, platelet count < 100x109/l, creatinine level >1.5 mg/dl, liver enzymes > 1.5 times above normal or alkaline phosphatase >3 times above normal
Clinical examination showing significant abnormalities of clinical relevance
Current evidence of significant abuse of drugs
Psychiatric disease/social situations that would limit compliance with study requirements