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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00686868
Registration number
NCT00686868
Ethics application status
Date submitted
28/05/2008
Date registered
30/05/2008
Date last updated
26/06/2017
Titles & IDs
Public title
Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients
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Scientific title
Clinical Phase I/IIA Study of Subcutaneously Administration of Ofatumumab in Rheumatoid Arthritis Patients on Stable Dose Methotrexate
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Secondary ID [1]
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OFA110867
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - placebo
Treatment: Drugs - ofatumumab
Experimental: 30mg - active
Experimental: 3mg - active
Experimental: 0.3mg - active
Placebo comparator: placebo - placebo
Experimental: 60mg - 60mg
Experimental: 100mg - 100mg
Other interventions: placebo
placebo
Treatment: Drugs: ofatumumab
fully human anti-CD20 monoclonal antibody
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and tolerability as described by the incidence and severity of adverse events [AEs], clinical laboratory parameters and vital signs.
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Assessment method [1]
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Timepoint [1]
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throughout the study
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Secondary outcome [1]
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Requirement for the use of pre-medication, including the timing, type and dose required.
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Assessment method [1]
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Timepoint [1]
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throughout study
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Secondary outcome [2]
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Pharmacodynamics (B-cell depletion and re-population) as measured by CD-19 peripheral blood B- lymphocyte count via routine fluorescent activated cell sorting (FACS) analysis.
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Assessment method [2]
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Timepoint [2]
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throughout study
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Secondary outcome [3]
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PK/PD parameters including estimation of time to re-population of CD-19 peripheral blood B-cells to above LLQ (and/or <95% depletion) following single subcutaneous dose of Ofatumumab.
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Assessment method [3]
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Timepoint [3]
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throughout study
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Secondary outcome [4]
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Immunogenicity as measured by the incidence, titre and type of human anti-human antibody (HAHA) immune response.
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Assessment method [4]
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Timepoint [4]
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throughout study
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Secondary outcome [5]
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Other pharmacodynamic/biomarkers of disease activity and immune status may include high sensitivity C-reactive protein (hsCRP), Erythrocyte Sedimentation Rate (ESR), B-Lymphocyte Stimulator (BLyS/BAFF), B-Lymphocyte Chemokine (BLC), IL-6,
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Assessment method [5]
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Timepoint [5]
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throughout study
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Secondary outcome [6]
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Immunoglobulins (IgA, IgG, IgM), Complement (CH50, C3, C4), IgM Rheumatoid Factor (IgM-RF), IgA-RF and IgG-RF, anti-cyclic citrullinated peptide antibody (aCCP),
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Assessment method [6]
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Timepoint [6]
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throughout study
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Secondary outcome [7]
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serum amyloid A (SAA), CD-3+, CD-4+ and CD-8+ lymphocytes or other biomarkers, as data permit.
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Assessment method [7]
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Timepoint [7]
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throughout study
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Secondary outcome [8]
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Pharmacodynamics (B-cell depletion and re-population) as measured by CD-19 peripheral blood B- lymphocyte count via routine FACS analysis.Other Secondary Endpoints
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Assessment method [8]
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Timepoint [8]
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throughout study
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Eligibility
Key inclusion criteria
Key
* Male or female aged = 18 years
* A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification) of at least six months prior to screening
* Subjects must be treated with MTX, 7.5-25 mg/week, for at least 12 weeks prior to Visit 2, with the last 4 weeks prior to Day 2 at a stable dosage
* Patient must be willing to receive folic acid =5mg/wk 4 weeks prior to baseline administered according to locally accepted practice
* Body mass index (BMI) < 35kg/m2 (inclusive)
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subjects with a history of a rheumatic autoimmune disease other than RA (except secondary Sjögren's syndrome), or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or Felty's syndrome)
* Previous exposure to biologic cell depleting anti-rheumatic therapies, including investigational compounds (e.g. anti-CD11a, anti-CD19, anti-CD20, anti-CD22, anti-BLyS/BAFF, anti-CD3, anti-CD4, anti-CD5, anti-CD52)
* Exposure to etanercept < 4 weeks, infliximab or adalimumab < 8 weeks, or abatacept or anakinra < 12 weeks prior to visit 2
* Received any of the following treatments within 4 weeks prior to Visit 2:
* Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues, monoclonal antibodies)
* Glucocorticoid unless given in doses equivalent to = 10 mg of prednisolone /day
* Intra-articular, i.m. or IV corticosteroids
* Live/attenuated vaccinations
* Cyclosporine
* Azathioprine
* Penicillamine
* Sulfasalazine
* Bucillamine
* Hydroxychloroquine
* Chloroquine
* Exposure to leflunomide within 12 weeks prior to visit 2 unless the subject has completed peroral cholestyramine treatment
* Exposure to gold therapy = 12 weeks prior to Visit 2
* Exposure to IV immunogammaglobulins = 24 weeks prior to Visit 2
* Past or current malignant melanoma
* Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, renal infection, chest infection with bronchiectasis, tuberculosis and active hepatitis B and C
* History of significant cerebrovascular disease
* Positive plasma / white cell JC Virus (JCV) PCR (either compartment)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/06/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/05/2011
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Sample size
Target
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Randwick
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Recruitment hospital [2]
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GSK Investigational Site - Adelaide
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Recruitment hospital [3]
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GSK Investigational Site - Heidelberg
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Recruitment hospital [4]
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GSK Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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United States of America
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Florida
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Belgium
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Brussels
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Belgium
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State/province [4]
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Leuven
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France
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Echirolles
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Italy
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Veneto
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New Zealand
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State/province [7]
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Christchurch
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Poland
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State/province [8]
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Bydgoszcz
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Country [9]
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Russian Federation
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State/province [9]
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Moscow
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Country [10]
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Russian Federation
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State/province [10]
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Ryazan
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Russian Federation
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State/province [11]
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Smolensk
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Russian Federation
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State/province [12]
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Yaroslavl
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Country [13]
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Spain
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State/province [13]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will examine the safety and tolerability, PK and PD of subcutaneously administered GSK1841157 in patients with RA on stable dose Methotrexate. The study comprises a single dose escalation/de-escalation phase to investigate the minimal efficacious dose based on PD markers with an acceptable safety profile.
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Trial website
https://clinicaltrials.gov/study/NCT00686868
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Trial related presentations / publications
Kurrasch R, Brown JC, Chu M, Craigen J, Overend P, Patel B, Wolfe S, Chang DJ. Subcutaneously administered ofatumumab in rheumatoid arthritis: a phase I/II study of safety, tolerability, pharmacokinetics, and pharmacodynamics. J Rheumatol. 2013 Jul;40(7):1089-96. doi: 10.3899/jrheum.121118. Epub 2013 Jun 1.
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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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 not provided in
https://clinicaltrials.gov/study/NCT00686868
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