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

May 14, 2018 updated by: University Hospital Tuebingen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

37

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, D-72076
        • Department of Internal Medicine II and Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Roferon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years)
Time Frame: 2 years
2 years
Time to improvement and remission
Time Frame: 2 years
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Ina Koetter, MD, Tuebingen University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKF 105-0-0
  • BMBF-01KG0706 (Other Grant/Funding Number: German Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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