ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00167583
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief 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.

Condition or disease Intervention/treatment Phase
Behcet's Disease Panuveitis Posterior Uveitis Retinal Vasculitis Drug: Cyclosporin A Drug: Interferon-alpha2a Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : November 2004
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Active Comparator: A Cyclosporin A
Cyclosporin A
Drug: Cyclosporin A
3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels
Other Name: Sandimmun neoral

Active Comparator: B Interferon alpha
Interferon-alpha2a
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.
Other Name: Roferon




Primary Outcome Measures :
  1. Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years) [ Time Frame: 2 years ]
  2. Time to improvement and remission [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Laboratory values for inflammatory activity (monthly) [ Time Frame: 2 years ]
  2. Number of switches from one treatment to the other [ Time Frame: 2 years ]
  3. Quality of life for patients with low vision (monthly) [ Time Frame: 2 years ]
  4. Number of ocular and non-ocular relapses (1 year, 2 years) [ Time Frame: 2 years ]
  5. Duration of the treatment-free period (second year) [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00167583


Locations
Germany
Department of Internal Medicine II and Department of Ophthalmology
Tuebingen, Germany, D-72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Ina Koetter, MD Tuebingen University Hospital

Additional Information:
Publications:

Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT00167583     History of Changes
Other Study ID Numbers: AKF 105-0-0
BMBF-01KG0706 ( Other Grant/Funding Number: German Ministry of Health )
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital Tuebingen:
Ocular Behcet`s disease
Panuveitis
Posterior Uveitis
Retinal vasculitis
Treatment
Interferon-alpha
Cyclosporin A

Additional relevant MeSH terms:
Uveitis
Vasculitis
Behcet Syndrome
Panuveitis
Uveitis, Posterior
Retinal Vasculitis
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Retinal Diseases
Interferons
Interferon-alpha
Cyclosporine
Cyclosporins
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors