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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	2 June 2020
Main ID:	EUCTR2004-004403-37-DE
Date of registration:	28/10/2005
Prospective Registration:	Yes
Primary sponsor:	Universitätsklinikum Heidelberg
Public title:	Eine monozentrische, randomisierte, kontrollierte Studie zur Untersuchung von Interferon-beta zur Behandlung der Multiplen-Sklerose (MS)-assoziierten und primären Uveitis intermedia im Vergleich zur Standardtherapie A monocentric, randomised, controlled trial for the investigation of Interferon-beta in the treatment of multiple-slerosis (MS)-associated and primary uveitis intermedia compared to the standardized treatment - TEAM-Studie
Scientific title:	Eine monozentrische, randomisierte, kontrollierte Studie zur Untersuchung von Interferon-beta zur Behandlung der Multiplen-Sklerose (MS)-assoziierten und primären Uveitis intermedia im Vergleich zur Standardtherapie A monocentric, randomised, controlled trial for the investigation of Interferon-beta in the treatment of multiple-slerosis (MS)-associated and primary uveitis intermedia compared to the standardized treatment - TEAM-Studie
Date of first enrolment:	27/02/2006
Target sample size:	34
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004403-37
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
Germany

Contacts

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Address:
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Affiliation:

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Key inclusion & exclusion criteria

Inclusion criteria:
- male and female patients who are at least 18 years old
- active, one or two-sided non-infectious uveitis intermedia for at least one year
- visual acuity ranging from at least 0,1 up to 0,6 on the worse eye, due to a macula edema (height of fovea > 180 micrometers)
- multiple sclerosis (if there is no primary uveitis intermedia)
- previous therapy with corticosteroids for a minimum of 4 weeks with at least 0,5 mg/kg body weight which has not been successful

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- a sole uveitis anterior
- no macula-edema
- an atrophy of the optic nerve after retro-bulbar-neuritis
- a peri- or intraocular injection of corticosteroids in the last 3 months
- a prior, unsuccesful, systemic treatment with prednisone
- a prior, unsuccesful, systemic treatment with acetacolamid (in order to treat macula edema)
- a known allergy against human or recombinant Interferon
- a psychiatric diagnosed endogenous depression
- diseases of the liver for which hepatotoxic pharmaceuticals cannot be tolerated
- infectious kinds of uveitis
- all systemic diseases except for MS
- pregnancy, lactation
- no contraception
- additional metabolic or psychiatric diseases or malignant tumor(s)

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Uveitis intermedia with inflammatory macula edema with or without associated Multiple Sclerosis

Intervention(s)

Product Name: Rebif
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 22-

Product Name: Rebif
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-

Product Name: Metex
Pharmaceutical Form: Cutaneous liquid
INN or Proposed INN: Methotrexat
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Main Objective: To measure any changes (as an arithmetic mean) of the visual acuity of both eyes

Secondary Objective: The reversion of ocular complications such as macula edema, intraocular inflammatory processes and neovascularisation or changes in the frequency of adverse events

Primary end point(s): N/A

Secondary Outcome(s)

Secondary ID(s)

N/A

TEAM-Studie

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 27/02/2006
Contact:

Results

Results available:	Yes
Date Posted:	30/05/2020
Date Completed:	31/03/2011
URL:	https://www.clinicaltrialsregister.eu/ctr-search/trial/2004-004403-37/results

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