Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2005-11-30
2006-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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SB-681323
Eligibility Criteria
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Inclusion Criteria
* Must use defined contraceptive methods if of child-bearing potential.
* BMI range: 18.5-35.0 kg/m2.
* Diagnosis of RA (rheumatoid arthritis) according to revised 1987 American College of Rheumatology (ACR) criteria.
* If other RA-medication is used: Disease-Modifying Anti-Rheumatic Drug (DMARDS) must be stable for at least 8 weeks before first trial visit.
* If other oral anti-RA therapies are used, these must have been stable at least 4 weeks before first trial visit.
* If Methotrexate medication is used as RA-therapy, Folate supplement must be taken with stable red cell folate levels.
* Must give informed consent.
* Must abstain from alcohol during the trial participation.
Exclusion Criteria
* Has a positive alcohol screen.
* Any history of liver disease.
* Positive Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of screening.
* Have any significant disease that places the subject at unacceptable risk as a participant in this trial.
* Acute infection.
* History of active tuberculosis.
* History of repeated or chronic infection.
* History of malignancy.
* History of HIV or other immunosuppressive diseases.
* Participated in a clinical trial within the last 3 months for non-biological therapies and 6 months for biological therapies.
* Uncontrolled diabetes or psoriasis.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Hvidovre, , Denmark
GSK Investigational Site
Augsburg, Bavaria, Germany
GSK Investigational Site
Hamburg, City state of Hamburg, Germany
GSK Investigational Site
Hamburg, City state of Hamburg, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, Germany
GSK Investigational Site
Hofheim, Hesse, Germany
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany
GSK Investigational Site
Halle, Saxony-Anhalt, Germany
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, Germany
GSK Investigational Site
Shatin, , Hong Kong
GSK Investigational Site
Foggia, Apulia, Italy
GSK Investigational Site
Benevento, Campania, Italy
GSK Investigational Site
Telese Terme (BN), Campania, Italy
GSK Investigational Site
Jesi (AN), The Marches, Italy
GSK Investigational Site
Pisa, Tuscany, Italy
GSK Investigational Site
Drammen, , Norway
GSK Investigational Site
Lillehammer, , Norway
GSK Investigational Site
Oslo, , Norway
GSK Investigational Site
Oslo, , Norway
GSK Investigational Site
Sarpsborg, , Norway
GSK Investigational Site
Stavanger, , Norway
GSK Investigational Site
Tønsberg, , Norway
GSK Investigational Site
Grudziądz, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Wroclaw, , Poland
GSK Investigational Site
A Coruña, , Spain
GSK Investigational Site
Baracaldo/Vizcaya, , Spain
GSK Investigational Site
Granada, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Mérida, , Spain
GSK Investigational Site
Santiago de Compostela, , Spain
GSK Investigational Site
Seville, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Gothenburg, , Sweden
GSK Investigational Site
Luleå, , Sweden
GSK Investigational Site
Wigan, Lancashire, United Kingdom
GSK Investigational Site
Metropolitan Borough of Wirral, Merseyside, United Kingdom
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Sheffield, , United Kingdom
Countries
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Other Identifiers
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RA1100849
Identifier Type: -
Identifier Source: org_study_id