Interferon-alpha2a Versus Cyclosporin A for Severe Ocular... | NCT00167583

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

NCT00167583

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

May 17, 2018Actual

Enrollment

37Actual

Phase

Phase 3

Conditions

Behcet's Disease
Panuveitis
Posterior Uveitis
Retinal Vasculitis

Interventions

Cyclosporin A
Interferon-alpha2a

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BMBF-01KG0706	Other Grant/Funding Number	German Ministry of Health

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2018

Last Update Posted Date

May 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A Cyclosporin A	Active Comparator	Cyclosporin A	Drug: Cyclosporin A
B Interferon alpha	Active Comparator	Interferon-alpha2a	Drug: Interferon-alpha2a

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyclosporin A	Drug	3 mg/kg bw, augmented to 5 mg if necessary and combined with prednisolone. Adapted to serum levels	A Cyclosporin A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Laboratory values for inflammatory activity (monthly)		2 years
Number of switches from one treatment to the other		2 years
Quality of life for patients with low vision (monthly)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ina Koetter, MD	Tuebingen University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Internal Medicine II and Department of Ophthalmology		Tübingen		D-72076	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15079763	Background	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.
15079762	Background	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.

ID	Term
D001528	Behcet Syndrome
D015864	Panuveitis
D015866	Uveitis, Posterior
D031300	Retinal Vasculitis

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D014606	Uveitis, Anterior
D014605	Uveitis

ID	Term
D016572	Cyclosporine
D000077190	Interferon alpha-2

ID	Term
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds