A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients

INTERVENTION: Trade Name: Prednisolone Tablets USP 5 mg Product Name: Prednisolone Tablets USP 5 mg Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolone CAS Number: 50‐24‐8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Rheumatoid arthritis PRIMARY OUTCOME: Main Objective: To relate clinical response in RA patients treated with prednisolone, with defined biochemical markers of inflammation 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 ; 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.; 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