A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients
- Conditions
- Rheumatoid arthritis
- Registration Number
- EUCTR2005-000902-30-GB
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method