Last updated: 07/17/2024 17:49:07
SB-681323 In Subjects With Rheumatoid Arthritis
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2006-19-10
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
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
Status
Study Complete
Location
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH4 2XU
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Telese Terme (BN), Campania, Italy, 82100
Status
Study Complete
Location
GSK Investigational Site
Wigan, Lancashire, United Kingdom, WN6 9EP
Status
Study Complete
Location
GSK Investigational Site
Wirral, Merseyside, United Kingdom, CH49 9PE
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Status
Study Complete
Location
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom, EH4 2X
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Valeggio sul Mincio, Veneto, Italy, 37067
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wigan, Lancashire, United Kingdom, WN6 9E
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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Access to clinical trial data by researchers
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