Rheumatoid arthritis
Conditions
Interventions
Trade Name: Prednisolone Tablets USP 5 mg
Product Name: Prednisolone Tablets USP 5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients between 25 and 75 years of age who meet the ACR criteria for diagnosis of rheumatoid arthritis, and in whom treatment with prednisolone is clinically indicated. 2. Active rheumatoid arthritis. 3. Currently on a stable treatment regimen. 4. The subject is capable of giving informed consent. 5. Willingness to continue on their current treatment regimen for the 2 weeks duration of the study with no change in dosage. 6. Women of childbearing potential willing to use dual barrier method contraception during the study period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any clinically relevant abnormality identified on the screening medical assessment (including medical history) that is considered by the investigator to represent a risk to the patient's safety during the study 2. Currently diagnosed with osteoporosis or on bisphosphonate therapy, or prior history of vertebral or compression fracture. 3. Diabetes or heart failure 4. Myocardial infarction within 6 months prior to dosing 5. Renal insufficiency (serum creatinine greater than 1.8) 6. History of untreated gastric or duodenal ulcer within 6 months prior to dosing 7. Use of Remicade (infliximab) or Humira (adalimumab) within 90 days prior to first dose of study medication. Use of Enbrel (etanercept) within 4 weeks prior to first dose of study medication. Use of Kineret (anakinra) within 1 week prior to first dose of study medication 8. Use of investigational biological therapies within 90 days prior to dosing and during the study 9. History of HIV disease, immunodeficiency, or use of immunosuppressants cyclophosphamide, cyclosporine, tacrolimus, mycophenolate mofetil, or azathioprine within 30 days prior dosing and during the study 10. Daily use of opiate analgesics in excess of: 180 mg codeine /day, propoxyphene 400 mg /day, oxycodone >30mg/day, morphine >60mg/day, or hydrocodone >30mg/day, are not permitted. 11. An acute systemic infection within 14 days prior to dosing 12. Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To relate clinical response in RA patients treated with prednisolone, with defined biochemical markers of inflammation; Secondary Objective: •To determine pharmacokinetics of oral prednisolone in RA patients, and its relationship to the clinical response measures and pharmacodynamic measure of LPS-induced cytokine release. •To evaluate the effect of prednisolone on whole blood gene expression in RA patients, as measured by microarray analysis and quantitative RT PCR. •To relate exposure to prednisolone in RA patients to levels of biochemical markers of bone formation and resorption (serum CTX I, NTX I, osteocalcin, P1NP). •To evaluate the effect of prednisolone on protein expression in RA patients as measured by protein array. ; Primary end point(s): •DAS28 score (composed of swollen and tender joint counts at 28 sites, General Health VAS score, and ESR). •The levels of selected markers of inflammation, which may include (but are not limited to) ESR, C-reactive protein, IL-6, Rheumatoid factor and soluble TNF-R | — |
Countries
United Kingdom
Outcome results
None listed