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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University Hospital Tuebingen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00167583
First received: September 9, 2005
Last updated: July 26, 2010
Last verified: March 2009

September 9, 2005
July 26, 2010
November 2004
September 2012   (final data collection date for primary outcome measure)
  • Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to improvement and remission [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 yearss)
  • Time to improvement and remission
Complete list of historical versions of study NCT00167583 on ClinicalTrials.gov Archive Site
  • Laboratory values for inflammatory activity (monthly) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of switches from one treatment to the other [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of life for patients with low vision (monthly) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of ocular and non-ocular relapses (1 year, 2 years) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Duration of the treatment-free period (second year) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Laboratory values for inflammatory activity (monthly)
  • Number of switches from one treatment to the other
  • Quality of life for patients with low vision (monthly)
  • Improvement of retinal function (monthly)
  • Number of ocular and non-ocular relapses (1 year, 2 years)
  • Duration of the treatment-free period (second year)
Not Provided
Not Provided
 
Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet`s Disease (INCYTOB)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Behcet's Disease
  • Panuveitis
  • Posterior Uveitis
  • Retinal Vasculitis
  • Drug: Cyclosporin A
    3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels
  • Drug: Interferon-alpha2a
    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.
  • Active Comparator: A
    Cyclosporin A
    Intervention: Drug: Cyclosporin A
  • Experimental: B
    Interferon-alpha2a
    Intervention: Drug: Interferon-alpha2a

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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
Both
18 Years to 75 Years
No
Contact: Ina Koetter, MD +49-7071-2985138 ina.koetter@med.uni-tuebingen.de
Contact: Christoph Deuter, MD christoph.deuter@med.uni-tuebingen.de
Germany
 
NCT00167583
AKF 105-0-0, BMBF-01KG0706
Yes
Prof. Ina Koetter, University Hospital Tuebingen
University Hospital Tuebingen
Not Provided
Principal Investigator: Ina Koetter, MD Tuebingen University Hospital
University Hospital Tuebingen
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP