Last updated: 07/17/2024 17:49:26

A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein that Is an Indicator For Rheumatoid Arthritis

GSK study ID
RA1104046
See study documents
Clinicaltrials.gov ID
NCT00134693
See results summary
EudraCT ID
2004-005115-29
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 SB681323 in patients with active RA to investigate the CRP dose response relationship
Trial description: This study is designed to compare a range of doses of SB-681323 with prednisolone, which has known effects on rheumatoid arthritis patients. By comparing the two drugs and their effects on blood proteins that indicate for rheumatoid arthritis, we hope to ascertain information on the most effective dose of SB-681323 to use in future.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Analysis for C-Reactive protein (CRP) levels 72 hours post-dose following SB-681323

Timeframe: Day 3 (at 72 hour)

Secondary outcomes:

Analysis of CRP levels 24 and 48 hours post-dose following SB-681323

Timeframe: Day 1 (at 24 hour) and Day 2 (at 48 hour)

Analysis of Interleukin (IL)-6 levels up to 72 hours post-dose following SB-681323

Timeframe: Upto Day 3 (at 1, 3, 24 and 72 hour)

Number of participants with adverse events (AE) and serious adverse events (SAE)

Timeframe: Upto Day 3 (72 hours)

Change from Baseline in vital sign systolic blood pressure (SBP) and diastolic blood pressure (DBP)

Timeframe: Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)

Change from Baseline in vital sign heart rate

Timeframe: Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)

Number of participants with abnormal electrocardiogram (ECG) findings

Timeframe: Day 1 (pre-dose, 1 hour and 3 hour)

Number of participants with clinical chemistry data outside the clinical concern range

Timeframe: Upto Day 3 (pre-dose, 24, 48 and 72 hours

Number of participants with hematology data outside the clinical concern

Timeframe: Upto Day 3 (pre-dose, 24 and 72 hours)

Number of participants with abnormal urinalysis dipstick results

Timeframe: Upto Day 3 (pre-dose, 24 and 72 hours)

Whole blood messenger RNA (mRNA) levels of tumor necrosis factor alpha [TNF-α], IL-8, IL-1β and Cyclo-oxygenase-2 [COX-2] (and other genes implicated in the pathogenesis of RA or genes involved in the mode of action of the compounds administered)

Timeframe: Pre-dose, 45 minutes, 90 minutes and 3 hours on Day 1

Interventions:
  • Drug: Prednisolone
  • Drug: SB-681323
    • Enrollment:
    77
    Primary completion date:
    2006-03-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Arthritis, Rheumatoid
    Product
    dilmapimod
    Collaborators
    Not applicable
    Study date(s)
    June 2005 to August 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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Amiens, Picardie, France, 80054
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 12163
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13125
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14059
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14109
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 25 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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-03-08
    Actual study completion date
    2006-03-08

    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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