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Clinical Trials/EUCTR2004-000803-17-LT
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

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.

Registry
who.int
Start Date
November 11, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
The SAVE trial group

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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