EUCTR2004-000803-17-LT
Active, Not Recruiting
N/A
Prospective, controlled clinical study on the effect of 120 mg depot-methyl-prednisolone compared to placebo on the course of recent onset arthritis - Very early steroid therapy in arthritis - the Stop Arthritis Very Early (SAVE) trial
The SAVE trial group0 sites400 target enrollmentNovember 11, 2005
ConditionsEarly undifferentiated arthritis
DrugsDepo-Medrol
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Early undifferentiated arthritis
- Sponsor
- The SAVE trial group
- Enrollment
- 400
- Status
- Active, Not Recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible to the trial are newly referred patients with
- •\- arthritis of at least one joint (out of 66 possible joints),
- •\- a duration of symptoms of inflammatory arthritis of 16 weeks at most,
- •\- no pre\-treatment with steroids for this indication
- •\- no pre\-treatment with a coxib for this indication
- •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
Exclusion Criteria
- •Excluded will be:
- •\-Patients under 18 yrs.
- •\-Patients with joint swelling due to trauma.
- •\-Patients with only DIP arthritis.
- •\-Patients with suspected or proven septic arthritis or gout.
- •\-Patients requiring oral anticoagulant therapy precluding i. m. injections
- •\-Patients who are pregnant.
- •\-Patients with a contraindication for Paracetamol
- •osevere liver function failure (Child\-Pugh \>9\)
- •osignificantly impaired kidney function (creatinine \>1,8 mg/dl)
Outcomes
Primary Outcomes
Not specified
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