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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00624338




Registration number
NCT00624338
Ethics application status
Date submitted
15/02/2008
Date registered
27/02/2008
Date last updated
14/03/2016

Titles & IDs
Public title
Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)
Scientific title
A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)
Secondary ID [1] 0 0
27646
Universal Trial Number (UTN)
Trial acronym
APRIL-SLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lupus Erythematosus, Systemic 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atacicept 75 mg
Treatment: Drugs - Atacicept 150 mg
Other interventions - Placebo Comparator

Experimental: Atacicept 75 mg -

Experimental: Atacicept 150 mg -

Placebo comparator: Placebo -


Treatment: Drugs: Atacicept 75 mg
75 milligram (mg) atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

Treatment: Drugs: Atacicept 150 mg
150 mg atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

Other interventions: Placebo Comparator
Placebo matched to atacicept injection will be administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B
Timepoint [1] 0 0
From screening up to Week 52
Secondary outcome [1] 0 0
Time to First New Flare as Defined by BILAG Score A or B
Timepoint [1] 0 0
From screening up to Week 52
Secondary outcome [2] 0 0
Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks
Timepoint [2] 0 0
From screening up to Week 24
Secondary outcome [3] 0 0
Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Mean Cumulative Corticosteroid Dose
Timepoint [4] 0 0
Randomization up to Week 52

Eligibility
Key inclusion criteria
* Male or female 16 years of age or older
* Disease history of at least six months meeting at least 4 out of the 11 American College of Rheumatology (ACR) criteria for SLE
* Active SLE with at least one British Isles Lupus Assessment Group (BILAG) flare A or B at screening requiring a change in the dose of corticosteroids
* Positive antinuclear antibody (ANA) or anti-double-stranded deoxyribonucleic acid (dsDNA) at screening
* Female subjects must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks prior to Study Day 1, during the trial and 24 weeks after the last dose of study medication
* Other protocol defined inclusion criteria could apply
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Active moderate to severe glomerulonephritis (kidney impairment) as defined in the protocol
* Active central nervous system SLE deemed to be severe/progressive and/or associated with significant cognitive impairment leading to inability to provide informed consent and/or comply with the protocol
* Previous treatment with rituximab, abatacept, or belimumab
* History of demyelinating disease such as multiple sclerosis (MS) or optic neuritis
* Other protocol defined exclusion criteria could apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
461
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Cairns
Recruitment hospital [2] 0 0
Research Site - Clayton, Victoria
Recruitment hospital [3] 0 0
Research Site - Sunshine Coast, Queensland
Recruitment hospital [4] 0 0
Research Site - Woodville S.A.
Recruitment postcode(s) [1] 0 0
- Cairns
Recruitment postcode(s) [2] 0 0
- Clayton, Victoria
Recruitment postcode(s) [3] 0 0
- Sunshine Coast, Queensland
Recruitment postcode(s) [4] 0 0
- Woodville S.A.
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
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United States of America
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Idaho
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United States of America
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Massachusetts
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United States of America
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Michigan
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New York
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United States of America
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Ohio
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Quilmes
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Argentina
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San Juan
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Argentina
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Tucuman
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Austria
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Wein
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Bulgaria
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Sofia
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Croatia
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Osijek
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Croatia
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Rijeka
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Croatia
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Split
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Croatia
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Zagreb
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Czech Republic
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Prague
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France
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Bordeaux Pessac
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France
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Lille
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France
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Montpelier Cedex
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France
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Paris
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France
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Strasbourg
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France
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Toulouse
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Hanover
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Germany
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Heidelberg
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Germany
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Herne
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Germany
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Munchen
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Germany
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Munster
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Greece
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Athens
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Greece
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Thessaloniki
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India
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Secunderabad, Andhra Pradesh
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Israel
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Haifa
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Israel
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Jerasalem
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Israel
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Petah-Tikva
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Israel
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Tel Aviv
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Lebanon
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Beirut
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Malaysia
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Kuala Lumpur
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Malaysia
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Perak
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Malaysia
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Seremban
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Mexico
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Guadalajara Jalisco
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Mexico
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Tijuana, BC
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Netherlands
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Amsterdam
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Leiden
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Netherlands
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Maastricht
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Philippines
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Pampanga
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Davao
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Iloilo
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Las Pinas
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Manila
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Bialystok
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Gdansk
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Krakow
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Lublin
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Szczecin
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Torun
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Poland
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Warsawa
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Russian Federation
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Kemerovo
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Russian Federation
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Petrozavodsk
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Russian Federation
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Ryazan
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Russian Federation
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Saratov
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Russian Federation
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St Petersburg
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Russian Federation
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Tula
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Niska Banja
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Serbia
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Novi Beograd
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Panorama, Western Cape
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South Africa
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Parlow, Western Cape
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South Africa
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Pinelands
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South Africa
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Stellenbosch, Western Cape
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Santiago de Compostela
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Switzerland
State/province [89] 0 0
St. Gallen
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Taiwan
State/province [90] 0 0
Taichung
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Taiwan
State/province [91] 0 0
Taipei
Country [92] 0 0
Taiwan
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Taoyuan
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Ternopil
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Ukraine
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Vinnytsya
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Ukraine
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Zhytomyr
Country [100] 0 0
United Kingdom
State/province [100] 0 0
London
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EMD Serono
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
Merck KGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00624338