Last updated: 07/14/2020 12:50:04
Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2006-18-11
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
- 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 not be morbidly obese.
Inclusion and exclusion 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
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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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