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

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ClinicalTrials.gov Identifier: NCT00256919
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : November 5, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE November 21, 2005
First Posted Date  ICMJE November 22, 2005
Last Update Posted Date November 5, 2012
Study Start Date  ICMJE November 2005
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2007)
C-reactive protein (CRP) levels 72 hours post-dose. [ Time Frame: 72 hours post-dose. ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2005)
Determine dose-response relationship for a range of doses (7.5, 20 and 60mg) of GW856553 on levels of a blood protein (CRP) associated with rheumatoid arthritis
Change History Complete list of historical versions of study NCT00256919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2007)
C-reactive protein (CRP) levels 24 and 48 hours post-dose [ Time Frame: 24 and 48 hours post-dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2005)
Determine plasma drug concentrations to allow characterisation of the action of the body on the drug.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)
Official Title  ICMJE 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
Brief Summary This study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE Drug: GW856553
Study Arms  ICMJE Not Provided
Publications * Yang S, Lukey P, Beerahee M, Hoke F. Population pharmacokinetics of losmapimod in healthy subjects and patients with rheumatoid arthritis and chronic obstructive pulmonary diseases. Clin Pharmacokinet. 2013 Mar;52(3):187-98. doi: 10.1007/s40262-012-0025-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2012)
51
Original Enrollment  ICMJE
 (submitted: November 21, 2005)
48
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Germany,   Spain,   Sweden,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00256919
Other Study ID Numbers  ICMJE RA3103730
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP