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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00930553




Registration number
NCT00930553
Ethics application status
Date submitted
26/06/2009
Date registered
30/06/2009
Date last updated
15/05/2017

Titles & IDs
Public title
An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
Scientific title
An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
Secondary ID [1] 0 0
2009-010788-18
Secondary ID [2] 0 0
CAMMS03409
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - alemtuzumab

Experimental: Previously treated with alemtuzumab - Alemtuzumab 12 mg per day administered through IV, once a day for 3 consecutive days (participants might receive additional cycles of alemtuzumab upon documented evidence of resumed disease activity, but not within same 12-month period)

Experimental: Previously treated with interferon beta-1a (Rebif®) - Alemtuzumab 12 mg per day administered through IV, once a day for 5 consecutive days during the first cycle and 12 mg per day administered through IV, once a day for 3 consecutive days during the second cycle, 12 months later. Participants might qualify for as-needed retreatment (12 mg per day administered through IV, once a day for 3 consecutive days) after their second fixed annual cycle.


Treatment: Other: alemtuzumab
Alemtuzumab 12 mg/day IV infusion on 5 consecutive days if the participants had no prior alemtuzumab exposure (ie, first treatment course). All subsequent treatment courses were for 3 days only.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualized Relapse Rate (ARR)
Timepoint [1] 0 0
Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively)
Primary outcome [2] 0 0
Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab
Timepoint [2] 0 0
Baseline (Year 0 of initial studies) up to Year 4
Primary outcome [3] 0 0
Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment
Timepoint [3] 0 0
Year 1 prior to retreatment, Year 1, 2, 3 after retreatment
Primary outcome [4] 0 0
Number of Participants With Sustained Accumulation of Disability (SAD)
Timepoint [4] 0 0
Baseline (Year 0) up to Year 6
Primary outcome [5] 0 0
Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison
Timepoint [5] 0 0
Baseline (Year 0 of initial studies) up to Year 4
Secondary outcome [1] 0 0
Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS at Year 6
Timepoint [1] 0 0
Baseline (Year 0) up to Year 6
Secondary outcome [2] 0 0
Number of Participants With Sustained Reduction in Disability (SRD) Assessed by EDSS (After Alemtuzumab Treatment) at Year 2 of the Extension Study
Timepoint [2] 0 0
Extension study (CAMMS03409) baseline up to Extension Year 2
Secondary outcome [3] 0 0
Change From Initial Study Baseline in EDSS Score at Year 3, 4, 5 and 6
Timepoint [3] 0 0
Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6
Secondary outcome [4] 0 0
Change From Initial Study Baseline in EDSS Score Before and After Alemtuzumab Treatment: 2 Year Comparison
Timepoint [4] 0 0
Baseline (Year 0 of initial studies) up to Year 4
Secondary outcome [5] 0 0
Change From Retreatment Baseline in EDSS Score After Alemtuzumab Retreatment
Timepoint [5] 0 0
Retreatment baseline, Year 1, 2 and 3 after retreatment baseline
Secondary outcome [6] 0 0
Percentage of Participants Without New or Enlarging Magnetic Resonance Imaging (MRI)-T2-Hypertense Lesion Activity
Timepoint [6] 0 0
Year 3, 4, 5 and 6
Secondary outcome [7] 0 0
Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Treatment
Timepoint [7] 0 0
Baseline (Year 0 of initial studies) up to Year 4
Secondary outcome [8] 0 0
Percentage of Participants Without New or Enlarging MRI-T2-Hypertense Lesion Activity Before and After Alemtuzumab Retreatment
Timepoint [8] 0 0
Retreatment Baseline, Year 1, 2 and 3 after retreatment
Secondary outcome [9] 0 0
Percentage Change From Baseline in MRI-T2-Hypertense Lesion Volumes at Year 3, 4, 5, 6
Timepoint [9] 0 0
Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6
Secondary outcome [10] 0 0
Percentage of Participants Without New Gadolinium-enhancing MRI Lesion Activity
Timepoint [10] 0 0
Year 3, 4, 5 and 6
Secondary outcome [11] 0 0
Percent Change From Baseline in Brain Parenchymal Fractions (BPF) at Year 3, 4, 5 and 6
Timepoint [11] 0 0
Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6
Secondary outcome [12] 0 0
Percentage of Relapse Free Participants
Timepoint [12] 0 0
Year 3, 4, 5 and 6
Secondary outcome [13] 0 0
Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey at Year 3, 4, 5 and 6
Timepoint [13] 0 0
Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "alemtuzumab treatment CAMMS323 extension group", "alemtuzumab Treatment CAMMS324 Extension" group, respectively),Year 3, 4, 5 and 6
Secondary outcome [14] 0 0
Change From Baseline in Physical Component Score (PCS) of Short Form-36 (SF-36) Health Survey Before and After Alemtuzumab Treatment: 2 Year Comparison
Timepoint [14] 0 0
Baseline (Year 0 of initial studies) up to Year 4
Secondary outcome [15] 0 0
Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) at Year 3, 4, 5, and 6
Timepoint [15] 0 0
Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6
Secondary outcome [16] 0 0
Change From Baseline in Mental Component Score (MCS) of Short Form-36 (SF-36) Before and After Alemtuzumab Treatment: 2 Year Comparison
Timepoint [16] 0 0
Baseline (Year 0 of initial studies) up to Year 4
Secondary outcome [17] 0 0
Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score at Year 3, 4, 5 and 6
Timepoint [17] 0 0
Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5, 6
Secondary outcome [18] 0 0
Change From Baseline in Self-reported Quality of Life as Assessed by Functional Assessment of Multiple Sclerosis (FAMS) Score Before and After Alemtuzumab Treatment: 2 Year Comparison
Timepoint [18] 0 0
Baseline (Year 0 of initial studies) up to Year 4
Secondary outcome [19] 0 0
Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score at Year 3, 4, 5 and 6
Timepoint [19] 0 0
Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively), Year 3, 4, 5 and 6
Secondary outcome [20] 0 0
Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Visual Analog Scale Score Before and After Alemtuzumab Treatment: 2 Year Comparison
Timepoint [20] 0 0
Baseline (Year 0 of initial studies) up to Year 4

Eligibility
Key inclusion criteria
* 1.Received alemtuzumab in CAMMS323 or CAMMS324, completed the 2-year study period, and had not subsequently received disease modifying treatments (other than glatiramer acetate or interferon beta); or
* 2.Received Rebif® in CAMMS323 or CAMMS324, completed the 2-year study period, and had not subsequently received alternative disease modifying treatments (other than glatiramer acetate or another interferon beta); or
* 3.Participated in CAMMS223.
* NOTE: Criteria 1 and 2 above meant that participants who enrolled in CAMMS323 or CAMMS324 but did not complete the 2-year study period or went on to receive non-study drug DMTs after randomization were not eligible for inclusion in the Extension Study. Participants who enrolled in CAMMS324 after participation in CAMMS223 must meet criteria 1 or 2 to be eligible for inclusion in the Extension Study.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any alemtuzumab participant from CAMMS223, CAMMS323, or CAMMS324 who had received alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies), or was participating in any other investigational study, unless approved by Genzyme. In addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab retreatment.
* Any Rebif® participants from CAMMS223, CAMMS323, or CAMMS324 who met any of the following criteria. In addition, these participants must be screened for disqualifying safety concerns before receiving alemtuzumab treatment. a) Did not wish to receive alemtuzumab; b) Ongoing participation in any other investigational study, unless approved by Genzyme; c) Had received alemtuzumab off-label (ie, outside of one of the prior Genzyme-sponsored studies); d) Known bleeding disorder or therapeutic anticoagulation; e) Diagnosis of idiopathic thrombocytopenia purpura or other autoimmune hematologic abnormality; f) History of malignancy, except basal cell skin carcinoma; g) Intolerance of pulsed corticosteroids, especially a history of steroid psychosis h) Significant Autoimmune disorder (other than MS); i) Major psychiatric disorder or epileptic seizures not adequately controlled by treatment; j) Active infection or high risk for infection k) Unwilling to use a reliable and acceptable contraceptive method during and for at least 6 months following each alemtuzumab treatment cycle (fertile participants only).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
Accrual to date
Final
1314
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Southern Neurology - Kogarah
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Gold Coast Hospital - Southport
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment hospital [8] 0 0
Austin Health - Heidelberg
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [10] 0 0
The Wesley Research Institute - Auchenflower QLD
Recruitment hospital [11] 0 0
The Queen Elizabeth Hospital - Woodville, SA
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Liverpool
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment postcode(s) [5] 0 0
- Southport
Recruitment postcode(s) [6] 0 0
- Hobart
Recruitment postcode(s) [7] 0 0
- Fitzroy
Recruitment postcode(s) [8] 0 0
- Heidelberg
Recruitment postcode(s) [9] 0 0
- Parkville
Recruitment postcode(s) [10] 0 0
- Auchenflower QLD
Recruitment postcode(s) [11] 0 0
- Woodville, SA
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
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United States of America
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Virginia
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Washington
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Argentina
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Buenos Aires
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Austria
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Vienna
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Esneux
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Leuven
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Brazil
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Porto Alegre
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Brazil
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Recife, PE
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Brazil
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São Paulo, SP
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Brazil
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São Paulo,SP
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Alberta
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Ontario
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Quebec
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London, ON
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Canada
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Ottawa, Ontario
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Canada
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Vancouver, BC
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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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Varazdin
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Croatia
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Zagreb
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Czechia
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Brno
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Hradec Kralove
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Prague
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Czechia
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Teplice
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Copenhagen
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Denmark
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Århus C
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France
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Dijon Cedex
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France
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Paris Cedex 13
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Rennes Cedex 9
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Strasbourg Cedex
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France
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Toulouse Cedex 9
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Germany
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DE
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Germany
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Berlin-Mitte
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Germany
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Dresden
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Germany
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Frankfurt am Main
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Germany
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Hamburg
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Hannover
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Germany
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Hennigsdorf
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Germany
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Ingolstadt
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Germany
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München
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Germany
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Rostock
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Ulm
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Wermsdorf
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Israel
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Ein Karem, Jerusalem
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Cagliari
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Italy
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Gallarate (Varese)
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Italy
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Orbassano (TO)
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Italy
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Roma
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Mexico
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Chihuahua, CHH
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Mexico
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Mexico City, DFE
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Netherlands
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Den Bosch
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Netherlands
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Sittard-Geleen
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Poland
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Krakow
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Lodz
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Lublin
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Poznan
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Poland
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Warsaw
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Pyatigorsk
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Russian Federation
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Ufa
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Nis
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Serbia
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Novi Sad
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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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Málaga
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Spain
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Seville
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Sweden
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Göteborg
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Sweden
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Umeå
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Ukraine
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Kharkov
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Ukraine
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Kiev-21
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Ukraine
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Kiev
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Ukraine
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Lviv
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United Kingdom
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Bristol
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United Kingdom
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Cambridge
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United Kingdom
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Cardiff
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United Kingdom
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London
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United Kingdom
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Salford
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United Kingdom
State/province [117] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genzyme, a Sanofi Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bayer
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 Monitor
Address 0 0
Genzyme Coorporation
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/NCT00930553