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Behcet's DiseasePhase 3INCYTOBNCT00167583

Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet's Disease (INCYTOB)

A Phase 3 study testing Cyclosporin A and Interferon-alpha2a in people with Behcet's Disease and Panuveitis, run by University Hospital Tuebingen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate if interferon-alpha2a is superior to the standard treatment with cyclosporin A for the treatment of severe ocular manifestations of Behcet's disease. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Behcet's Disease, Panuveitis, Posterior Uveitis
What is being tested?
Cyclosporin A and Interferon-alpha2a
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteGermany
Study dates
Nov 2004to Dec 2014
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Behçet's disease fulfilling the International Study Group Criteria with active pan- or posterior uveitis (according to the posterior uveitis scoring system) or retinal vasculitis and active disease according to the Behcet's Disease activity scoring system.

Who cannot join

  • Previous treatment with interferon-α or cyclosporin A
  • Pregnancy, breast feeding women, malignancy
  • Renal impairment (creatinine > 1.5 mg/dl)
  • Uncontrolled hypertension or diabetes
  • Depression or other psychic disorders(also history of depression)
  • History of acute or chronic inflammatory joint or autoimmune disease
Show all 15Show fewer
  • Organ or bone marrow transplant recipient, cardiac failure > NYHAIII
  • Acute liver disease with SGPT 2x above normal
  • White blood cell count < 3500/mm3
  • Platelet count < 100000/mm3
  • Hgb < 8.5g/dl
  • Body weight <45 kg
  • Alcohol abuse or drug abuse
  • Mental impairment
  • Uncooperative attitude

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Internal Medicine II and Department of Ophthalmology

    Tübingen, D-72076

Other trials in Germany

About this study

Official title: Phase III Study of Recombinant Human Interferon-alpha2a Versus Cyclosporin A for the Treatment of Ocular Behcet's Disease - a National,Randomised, Single-masked Controlled Trial (INCYTOB)

The purpose of this study is to investigate if interferon-alpha2a is superior to the standard treatment with cyclosporin A for the treatment of severe ocular manifestations of Behcet's disease.

Read the detailed description

Behcet's disease is a multisystem vasculitis often involving ocular (retinal) blood vessels (in 70% of all cases). This form of uveitis or retinal vasculitis still leads to blindness in 25 to 50% of the patients irrespective of immunosuppressive treatment.

The aim of the study is to evaluate if Interferon-alpha2a is superior to the present standard treatment (cyclosporin A (CSA)) for severe ocular (panuveitis, posterior uveitis, retinal vasculitis) Behçet's Disease (BD) and significantly improves visual prognosis and quality of health and life of the patients with ocular BD and is acting more rapidly than standard treatment. Furthermore, we want to evaluate if IFN-α induces long term remissions of ocular BD which can be maintained without further medical treatment.

The patients are randomised into two treatment groups (IFN/CSA) and treated for one year according to an algorithm which adapts dosages to clinical course. A crossover from one treatment arm to the other is planned in case of inefficacy.

Being tested
Cyclosporin A, Interferon-alpha2a
Keywords
Ocular Behcet's disease, Panuveitis, Posterior Uveitis, Retinal vasculitis, Treatment, Interferon-alpha, Cyclosporin A
Medical subject headings
Behcet Syndrome, Panuveitis, Uveitis, Posterior, Retinal Vasculitis

What participants receive

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

  • Cyclosporin ADrug

    Also called Sandimmun neoral

    3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels

  • Interferon-alpha2aDrug

    Also called Roferon

    3-6 million iU per day sc., augmented to up to 9 if necessary, later reduced (according to clinical response) to 3 x 3 million iU /week.

Study groups in NCT00167583
Study groupRoleWhat they receive
A Cyclosporin AActive comparatorCyclosporin A
Receives: Drug: Cyclosporin A
B Interferon alphaActive comparatorInterferon-alpha2a
Receives: Drug: Interferon-alpha2a

What is being measured

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

  1. Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years)

    Measured: 2 years

  2. Time to improvement and remission

    Measured: 2 years

Secondary outcomes (5)

  1. Laboratory values for inflammatory activity (monthly)

    Measured: 2 years

  2. Number of switches from one treatment to the other

    Measured: 2 years

  3. Quality of life for patients with low vision (monthly)

    Measured: 2 years

  4. Number of ocular and non-ocular relapses (1 year, 2 years)

    Measured: 2 years

  5. Duration of the treatment-free period (second year)

    Measured: 2 years

Timeline

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

  1. First posted14 Sep 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionDec 2014
  4. Study completionDec 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00167583
Sponsor's protocol ID
AKF 105-0-0
Other IDs
BMBF-01KG0706
Acronym
INCYTOB
Status last verified
May 2016
First submitted
9 Sep 2005
Last updated
17 May 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Kotter I, Gunaydin I, Zierhut M, Stubiger N. The use of interferon alpha in Behcet disease: review of the literature. Semin Arthritis Rheum. 2004 Apr;33(5):320-35. doi: 10.1016/j.semarthrit.2003.09.010.

    PubMed 15079763

  • Kotter I, Vonthein R, Zierhut M, Eckstein AK, Ness T, Gunaydin I, Grimbacher B, Blaschke S, Peter HH, Stubiger N. Differential efficacy of human recombinant interferon-alpha2a on ocular and extraocular manifestations of Behcet disease: results of an open 4-center trial. Semin Arthritis Rheum. 2004 Apr;33(5):311-9. doi: 10.1016/j.semarthrit.2003.09.005.

    PubMed 15079762

  • Kotter I, Zierhut M, Eckstein AK, Vonthein R, Ness T, Gunaydin I, Grimbacher B, Blaschke S, Meyer-Riemann W, Peter HH, Stubiger N. Human recombinant interferon alfa-2a for the treatment of Behcet's disease with sight threatening posterior or panuveitis. Br J Ophthalmol. 2003 Apr;87(4):423-31. doi: 10.1136/bjo.87.4.423.

    PubMed 12642304

  • Stuebiger N, Koetter I, Zierhut M. Complete regression of retinal neovascularization after therapy with interferon alfa in Behcet's disease. Br J Ophthalmol. 2000 Dec;84(12):1437-8. doi: 10.1136/bjo.84.12.1432g. No abstract available.

    PubMed 11186866

  • Kotter I, Aepinus C, Graepler F, Gartner V, Eckstein AK, Stubiger N, Kaskas B, Zierhut M, Bultmann B, Kandolf R, Kanz L. HHV8 associated Kaposi's sarcoma during triple immunosuppressive treatment with cyclosporin A, azathioprine, and prednisolone for ocular Behcet's disease and complete remission of both disorders with interferon alpha. Ann Rheum Dis. 2001 Jan;60(1):83-6. doi: 10.1136/ard.60.1.83. No abstract available.

    PubMed 11114291

  • Deuter CM, Kotter I, Gunaydin I, Zierhut M, Stubiger N. [Ocular involvement in Behcet's disease: first 5-year-results for visual development after treatment with interferon alfa-2a]. Ophthalmologe. 2004 Feb;101(2):129-34. doi: 10.1007/s00347-003-0927-7. German.

    PubMed 14991308

  • Kotter I, Deuter C, Stubiger N, Zierhut M. Interferon-a (IFN-a) application versus tumor necrosis factor-a antagonism for ocular Behcet's disease: focusing more on IFN. J Rheumatol. 2005 Aug;32(8):1633; author reply 1634. No abstract available.

    PubMed 16078350

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclosporin A and Interferon-alpha2a in people with Behcet's Disease and Panuveitis, run by University Hospital Tuebingen 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 1 inclusion and 15 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: finished, as of the sponsor's last update on 17 May 2018. 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 disease activity and preservation of visual acuity (monthly, at one and 2 years) (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT00167583, which also lists 7 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 17 May 2018.

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