Very early steroid therapy in arthritis - the Stop Arthritis Very Early (SAVE) trial

Completed

• Conditions: Early arthritis with a symptom duration of less than four months; Musculoskeletal Diseases; Arthritis

• Registration Number: ISRCTN86668322
• Lead Sponsor: Vienna Medical University (Austria)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Newly referred patients with:
1. Arthritis of at least one joint (out of 66 possible joints)
2. A duration of symptoms of inflammatory arthritis of 16 weeks at most
3. No pre-treatment with steroids for this indication
4. No pre-treatment with a coxib for this indication

Exclusion Criteria

1. Patients under 18 years
2. Patients with joint swelling due to trauma
3. Patients with only distal interphalangeal (DIP) arthritis
4. Patients with suspected or proven septic arthritis or gout
5. Patients requiring oral anticoagulant therapy precluding intramuscular injections
6. Patients who are pregnant
7. Patients with a contraindication for paracetamol
8. Severe liver function failure (Child-Pugh >9)
9. Significantly impaired kidney function (creatinine >1.8 mg/dl)
10. Gilbert-Meulengracht's syndrome
11. Patients with a contraindication for Non Steroidal Anti-Inflammatory Drugs (NSAIDs) and/or coxibs
12. A history of sulfonamide allergy
13. Active gastric or duodenal ulcer or gastrointestinal bleeding
14. A history of exacerbation of asthma, urticaria, or angioedema following NSAID or aspirin intake
15. Severe liver function failure (Child-Pugh >9)
16. Significantly impaired kidney function (creatinine >1.8 mg/dl)
17. Severe heart failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified