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

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Brief Title

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

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)

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.
    

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Laboratory values for inflammatory activity (monthly)

Condition

Behcet's Disease

Intervention

Cyclosporin A

Study Arms / Comparison Groups

 A Cyclosporin A
Description:  Cyclosporin A

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

37

Start Date

November 2004

Completion Date

December 2014

Primary Completion Date

December 2014

Eligibility 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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Ina Koetter, MD, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00167583

Organization ID

AKF 105-0-0

Secondary IDs

BMBF-01KG0706

Responsible Party

Sponsor

Study Sponsor

University Hospital Tuebingen


Study Sponsor

Ina Koetter, MD, Principal Investigator, Tuebingen University Hospital


Verification Date

May 2016