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

• Conditions: Early undifferentiated arthritis

• Registration Number: EUCTR2004-000803-17-LT
• Lead Sponsor: The SAVE trial group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

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
F.1.3.1 Number of subjects for this age range

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)
oGilbert-Meulengracht's syndrome
-Patients with a contraindication for NSAIDs and/or coxibs:
oa history of sulfonamide allergy
oactive gastric- or duodenal ulcer or gastrointestinal bleeding
oa history of exacerbation of asthma, uticaria, or angioedema following NSAID- or aspirin intake.
osevere liver function failure (Child-Pugh >9)
osignificantly impaired kidney function (creatinine >1,8 mg/dl)
osevere heart failure

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether patients with recent onset arthritis have a higher chance to be in remission both at 12 weeks and after one year of follow-up, if treated with 120mg Methyl-Prednisolone as compared to a placebo-injection.;Secondary Objective: ;Primary end point(s): The primary outcome will be the presence of clinical remission both at week 12 and at 1year