Adalimumab in Uveitis Refractory to Conventional Therapy (ADUR Trial)

NCT00348153 | Unknown Phase 2

• 1 other identifier: EudraCT: 2006-001732-53
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveitis

Keywords

Uveitis; Adalimumab; TNF alpha

Outcome Measures

Primary Outcomes (1)

• Improvement of visual acuity (3 lines EDTRS)

  at week 0, 2, 6, 12 and 24

Secondary Outcomes (5)

• Improvement of intraocular inflammatory activity

  at week 0, 2, 6, 12 and 24

• Evolution of cystoid macula edema(FLA, OCT)

  at week 0, 6, 12 and 24

• Number of switchers from Arm A to Arm B

  after six months

• Cumulative steroid dosage

  after six months

• Frequency of adverse events

  whole study period

Study Arms (2)

Adalimumab + corticosteroids + immunosuppressive treatments

EXPERIMENTAL

Adalimumab 40 mg eow, stable immunosuppression, corticosteroids in 1 mg/kg/Bodyweight (max. 80 mg) and taper

Drug: Adalimumab

immunosuppressive treatment + corticosteroids

ACTIVE COMPARATOR

corticosteroids upped to 1mg/kg/Bodyweight and taper, stable immunosuppressive treatment

Drug: Adalimumab

Interventions

Adalimumab DRUG

Adalimumab + corticosteroids + immunosuppressive treatments; immunosuppressive treatment + corticosteroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead
• Abbott: collaborator

Study Sites (1)

Interdisciplinary Uveitis Center, University of Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (4)

• Becker MD, Smith JR, Max R, Fiehn C. Management of sight-threatening uveitis: new therapeutic options. Drugs. 2005;65(4):497-519. doi: 10.2165/00003495-200565040-00005.

  PMID: 15733012 BACKGROUND

• Lim L, Suhler EB, Smith JR. Biologic therapies for inflammatory eye disease. Clin Exp Ophthalmol. 2006 May-Jun;34(4):365-74. doi: 10.1111/j.1442-9071.2006.01225.x.

  PMID: 16764659 BACKGROUND

• Suhler EB, Smith JR, Wertheim MS, Lauer AK, Kurz DE, Pickard TD, Rosenbaum JT. A prospective trial of infliximab therapy for refractory uveitis: preliminary safety and efficacy outcomes. Arch Ophthalmol. 2005 Jul;123(7):903-12. doi: 10.1001/archopht.123.7.903.

  PMID: 16009830 BACKGROUND

• Smith JR, Levinson RD, Holland GN, Jabs DA, Robinson MR, Whitcup SM, Rosenbaum JT. Differential efficacy of tumor necrosis factor inhibition in the management of inflammatory eye disease and associated rheumatic disease. Arthritis Rheum. 2001 Jun;45(3):252-7. doi: 10.1002/1529-0131(200106)45:33.0.CO;2-5.

  PMID: 11409666 BACKGROUND

MeSH Terms

Conditions

Uveitis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hannes M Lorenz, MD

  Department of Rheumatology, University of Heidelberg

  PRINCIPAL INVESTIGATOR

• Matthias D Becker, MD

  Interdisziplinary Uveitis Center, University of Heidelberg

  PRINCIPAL INVESTIGATOR

• Regina Max, MD

  Interdisziplinary Uveitis Center, University of Heidelberg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: July 3, 2006
• First Posted: July 4, 2006
• Study Start: August 1, 2006
• Primary Completion: September 1, 2012
• Study Completion: March 1, 2013
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

DE (1)