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UveitisPhase 2/3NCT00348153

Adalimumab in Uveitis Refractory to Conventional Therapy (ADUR Trial)

A Phase 2/3 study testing Adalimumab in people with Uveitis, run by Heidelberg University at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Uveitis
What is being tested?
Adalimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteGermany
Study dates
Aug 2006to Mar 2013
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Interdisciplinary Uveitis Center, University of Heidelberg

    Heidelberg, 69120

Other trials in Germany

About this study

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)

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.

Read the 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.

Conditions
Uveitis
Being tested
Adalimumab
Keywords
Uveitis, Adalimumab, TNF alpha
Medical subject headings
Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00348153
Study groupRoleWhat they receive
Adalimumab + corticosteroids + immunosuppressive treatmentsExperimentalAdalimumab 40 mg eow, stable immunosuppression, corticosteroids in 1 mg/kg/Bodyweight (max. 80 mg) and taper
Receives: Drug: Adalimumab
immunosuppressive treatment + corticosteroidsActive comparatorcorticosteroids upped to 1mg/kg/Bodyweight and taper, stable immunosuppressive treatment
Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of visual acuity (3 lines EDTRS)

    Measured: at week 0, 2, 6, 12 and 24

Secondary outcomes (5)

  1. Improvement of intraocular inflammatory activity

    Measured: at week 0, 2, 6, 12 and 24

  2. Evolution of cystoid macula edema(FLA, OCT)

    Measured: at week 0, 6, 12 and 24

  3. Number of switchers from Arm A to Arm B

    Measured: after six months

  4. Cumulative steroid dosage

    Measured: after six months

  5. Frequency of adverse events

    Measured: whole study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionSep 2012
  4. Study completionMar 2013 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00348153
Sponsor's protocol ID
EudraCT: 2006-001732-53
Status last verified
Nov 2012
First submitted
3 Jul 2006
Last updated
3 Dec 2012
Results posted
No

Publications

  • 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.

    PubMed 15733012

  • 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.

    PubMed 16764659

  • 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.

    PubMed 16009830

  • 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.

    PubMed 11409666

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Adalimumab in people with Uveitis, run by Heidelberg University at 1 site in Germany.

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 8 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 3 Dec 2012. 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 Germany. 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. 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?

Results are not available in the source record.

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?

Improvement of visual acuity (3 lines EDTRS) (time frame: at week 0, 2, 6, 12 and 24). 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 NCT00348153, which also lists 4 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 3 Dec 2012.

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