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

SB-681323 In Subjects With Rheumatoid Arthritis

GSK study ID
RA1100849
See study documents
Clinicaltrials.gov ID
NCT00320450
See results summary
EudraCT ID
2005-002219-26
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, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)
Trial description: The purpose of this research is to find out how effective and safe SB-681323 will be in the treatment of RA when it is added to standard anti-rheumatic treatments.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Serum levels of C-Reactive Protein (CRP) at the end of study (after 28 days of treatment) following repeat dosing with SB-681323

Timeframe: At Day 28

Secondary outcomes:

Serum levels of CRP at other available time points

Timeframe: Up to 22 days

Mean Change from Baseline in Disease Activity Score using 28 tender and swollen joints counts (DAS28) clinical scores

Timeframe: Baseline (Day 1 pre-dose) and Day 15 and 28

Number of participants with American College of Rheumatology (ACR) response

Timeframe: Up to Day 28

Change from baseline in Mean Tender or painful joints count and swollen joints count at indicated time points

Timeframe: Baseline (Day 1), Day 15 and Day 28

Change from baseline in Patient’s and physician’s global assessment of arthritis condition -VAS

Timeframe: Baseline (Day 1), Day 15 and Day 28

Change from baseline in Patient’s assessment of pain-VAS

Timeframe: Baseline (Day 1) and Day 15 and 28

Number of participants with Adverse events (AEs) and Serious adverse Events (SAEs)

Timeframe: Up to 28 days post last dose (Day 28)

Change from baseline in systolic and diastolic blood pressure (BP)

Timeframe: Day 1 pre-dose (Baseline) and Day 15, Day 28 and follow-up (28 days post last dose [Day 28])

Change from Baseline in pulse rate

Timeframe: Day 1 pre-dose (Baseline) and Day 15, Day 28 and follow-up (28 days post last dose [Day 28])

Change from baseline in weight

Timeframe: Day 1 pre-dose (Baseline) and Day 15, Day 28 and follow-up (28 days post last dose [Day 28])

Number of participants with abnormal Electrocardiogram (ECG) Values

Timeframe: Up to follow-up (28 days post last dose)

Change from Baseline in laboratory assessments- Alanine Amino Transferase (ALT), aspartate amino transferase (AST), Gamma Glutamyl Transferase (GGT) and Alkaline Phosphatase (ALP)

Timeframe: Up to 28 days

Change from baseline in values of laboratory assessments- total, direct and indirect bilirubin

Timeframe: Up to 28 days

ESR values

Timeframe: Day 1 pre-dose (Baseline) and Day 15, Day 28

Population pharmacokinetic (PK) parameters for SB-681323-oral clearance (CL)

Timeframe: Pre-dose, 15-45 minutes and 2-4 hours post-dose on Day 1, 15 and 28

Population pharmacokinetic (PK) parameters for SB-681323- volume of distribution (V2)

Timeframe: Pre-dose, 15-45 minutes and 2-4 hours post-dose on Day 1, 15 and 28

Population pharmacokinetic (PK) parameters for SB-681323-absorption rate constant (KA)

Timeframe: Pre-dose, 15-45 minutes and 2-4 hours post-dose on Day 1, 15 and 28.

Biomarkers of inflammation-Serum Interleukin-6 (IL-6), Transforming Growth Factor-alpha (TNFα)

Timeframe: Up to 28 days

Biomarkers of inflammation - Matrix metalloproteinase (MMP)-3

Timeframe: Up to 28 days

Biomarkers of inflammation - Serum Amyloid A

Timeframe: Up to 28 days

Biomarkers of inflammation-Fibrinogen

Timeframe: Up to 28 days

Biomarkers of inflammation- Messenger Ribonucleic Acid (mRNA)

Timeframe: Up to 28 days

Change from baseline in Functional disability index (Health Assessment Questionnaire [HAQ])

Timeframe: Day 1 (Baseline) and Day 15, 28

Change from baseline in levels of fatigue (Multidimensional Assessment of Fatigue [MAF])

Timeframe: Baseline (Day 1) and Day 28

Interventions:
  • Drug: SB-681323
  • Drug: Placebo
    • Enrollment:
    79
    Primary completion date:
    2006-19-10
    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)
    November 2005 to October 2006
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Females cannot be pregnant or lactating.
    • Must use defined contraceptive methods if of child-bearing potential.
    • Non-responder on biological RA treatment.
    • Has a positive alcohol screen.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Females cannot be pregnant or lactating.
    • 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:
    • Non-responder on biological RA treatment.
    • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Santiago de Compostela, Spain, 15706
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Frankfurt, Hessen, Germany, 60433
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Luebeck, Schleswig-Holstein, Germany, 23538
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Foggia, Puglia, Italy, 71100
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Granada, Spain, 18014
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shatin, Hong Kong
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 54 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
    2006-19-10
    Actual study completion date
    2006-19-10

    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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