Last updated: 07/14/2020 12:50:04

Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)

GSK study ID
RA3103730
See study documents
Clinicaltrials.gov ID
NCT00256919
EudraCT ID
2005-002969-37
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the C-Reactive Protein (CRP) dose response relationship
Trial description: This study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

C-reactive protein (CRP) levels 72 hours post-dose.

Timeframe: 72 hours post-dose.

Secondary outcomes:

C-reactive protein (CRP) levels 24 and 48 hours post-dose

Timeframe: 24 and 48 hours post-dose

Interventions:
  • Drug: GW856553
    • Enrollment:
    51
    Primary completion date:
    2006-18-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Arthritis, Rheumatoid
    Product
    losmapimod
    Collaborators
    Not applicable
    Study date(s)
    November 2005 to November 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.
    • Must have 3 or more swollen or 3 or more tender/painful joints at screening.
    • Must be on stable weekly methotrexate (2.5mg-25mg) for at least eight weeks prior to screening. Exclusion criteria:
    • Must not be morbidly obese.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bad Bramstedt, Schleswig-Holstein, Germany, 24576
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Donetsk, Ukraine, 83045
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Erlangen, Bayern, Germany, 91056
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 21075
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kharkiv, Ukraine, 61002
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kiev, Ukraine, 01030
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 16 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2006-18-11
    Actual study completion date
    2006-18-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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