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Adalimumab in Uveitis Refractory to Conventional Therapy (ADUR Trial)

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ClinicalTrials.gov Identifier: NCT00348153
Recruitment Status : Unknown
Verified November 2012 by Friederike Mackensen, University of Heidelberg.
Recruitment status was:  Active, not recruiting
First Posted : July 4, 2006
Last Update Posted : December 3, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Uveitis Drug: Adalimumab Phase 2 Phase 3

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study to Evaluate the Efficacy of Adalimumab in Patients With Different Forms of Refractory Uveitis Acronym: Adalimumab in Uveitis Refractory to Conventional Therapy (ADUR Trial)
Study Start Date : August 2006
Primary Completion Date : September 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Adalimumab + corticosteroids + immunosuppressive treatments
Adalimumab 40 mg eow, stable immunosuppression, corticosteroids in 1 mg/kg/Bodyweight (max. 80 mg) and taper
Drug: Adalimumab
Active Comparator: immunosuppressive treatment + corticosteroids
corticosteroids upped to 1mg/kg/Bodyweight and taper, stable immunosuppressive treatment
Drug: Adalimumab


Outcome Measures

Primary Outcome Measures :
  1. Improvement of visual acuity (3 lines EDTRS) [ Time Frame: at week 0, 2, 6, 12 and 24 ]

Secondary Outcome Measures :
  1. Improvement of intraocular inflammatory activity [ Time Frame: at week 0, 2, 6, 12 and 24 ]
  2. Evolution of cystoid macula edema(FLA, OCT) [ Time Frame: at week 0, 6, 12 and 24 ]
  3. Number of switchers from Arm A to Arm B [ Time Frame: after six months ]
  4. Cumulative steroid dosage [ Time Frame: after six months ]
  5. Frequency of adverse events [ Time Frame: whole study period ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348153


Locations
Germany
Interdisciplinary Uveitis Center, University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Abbott
Investigators
Principal Investigator: Hannes M Lorenz, MD Department of Rheumatology, University of Heidelberg
Principal Investigator: Matthias D Becker, MD Interdisziplinary Uveitis Center, University of Heidelberg
Study Director: Regina Max, MD Interdisziplinary Uveitis Center, University of Heidelberg
More Information

Additional Information:
Publications:
Responsible Party: Friederike Mackensen, PD Dr. med., University of Heidelberg
ClinicalTrials.gov Identifier: NCT00348153     History of Changes
Other Study ID Numbers: EudraCT: 2006-001732-53
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012

Keywords provided by Friederike Mackensen, University of Heidelberg:
Uveitis
Adalimumab
TNF alpha

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases
Adalimumab
Immunosuppressive Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs