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

Primary Purpose

Behcet's Disease, Panuveitis, Posterior Uveitis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Cyclosporin A
Interferon-alpha2a
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behcet's Disease focused on measuring Ocular Behcet's disease, Panuveitis, Posterior Uveitis, Retinal vasculitis, Treatment, Interferon-alpha, Cyclosporin A

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Internal Medicine II and Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A Cyclosporin A

B Interferon alpha

Arm Description

Cyclosporin A

Interferon-alpha2a

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2005
Last Updated
May 14, 2018
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT00167583
Brief Title
Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet's Disease (INCYTOB)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behcet's Disease, Panuveitis, Posterior Uveitis, Retinal Vasculitis
Keywords
Ocular Behcet's disease, Panuveitis, Posterior Uveitis, Retinal vasculitis, Treatment, Interferon-alpha, Cyclosporin A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A Cyclosporin A
Arm Type
Active Comparator
Arm Description
Cyclosporin A
Arm Title
B Interferon alpha
Arm Type
Active Comparator
Arm Description
Interferon-alpha2a
Intervention Type
Drug
Intervention Name(s)
Cyclosporin A
Other Intervention Name(s)
Sandimmun neoral
Intervention Description
3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels
Intervention Type
Drug
Intervention Name(s)
Interferon-alpha2a
Other Intervention Name(s)
Roferon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of disease activity and preservation of visual acuity (monthly, at one and 2 years)
Time Frame
2 years
Title
Time to improvement and remission
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Laboratory values for inflammatory activity (monthly)
Time Frame
2 years
Title
Number of switches from one treatment to the other
Time Frame
2 years
Title
Quality of life for patients with low vision (monthly)
Time Frame
2 years
Title
Number of ocular and non-ocular relapses (1 year, 2 years)
Time Frame
2 years
Title
Duration of the treatment-free period (second year)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ina Koetter, MD
Organizational Affiliation
Tuebingen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Internal Medicine II and Department of Ophthalmology
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15079763
Citation
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.
Results Reference
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PubMed Identifier
15079762
Citation
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.
Results Reference
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PubMed Identifier
12642304
Citation
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.
Results Reference
background
PubMed Identifier
11186866
Citation
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.
Results Reference
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PubMed Identifier
11114291
Citation
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.
Results Reference
background
PubMed Identifier
14991308
Citation
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.
Results Reference
background
PubMed Identifier
16078350
Citation
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.
Results Reference
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Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet's Disease (INCYTOB)

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