Very early steroid therapy in arthritis - the Stop Arthritis Very Early (SAVE) trial
| ISRCTN | ISRCTN86668322 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86668322 |
| Clinical Trials Information System (CTIS) | 2004-000803-17 |
| Protocol serial number | Study protocol - version IX, EudraCT number 2004-000803-17 |
| Sponsor | Vienna Medical University (Austria) |
| Funder | European League Against Rheumatism (EULAR) grant |
- Submission date
- 24/11/2005
- Registration date
- 10/03/2006
- Last edited
- 14/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Klaus Machold
Scientific
Scientific
Vienna Medical University
Department of Internal Medicine III
Division of Rheumatology
Wahringer Gurtel 18-20
Vienna
A-1090
Austria
| Phone | +43 (0)140 400 4381 |
|---|---|
| klaus.machold@meduniwien.ac.at |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized placebo-controlled multicentre clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | SAVE |
| Study objectives | The primary hypothesis underlying this clinical trial is that in patients with early inflammatory arthritis, one intramuscular injection with 120 mg of methyl-prednisolone (depot formula) will result in 10 to 15% more clinical remissions compared to one placebo injection |
| Ethics approval(s) | Approved by the Internal Review Boards and Ethical Committees of the Vienna Medical University and all other participating centres on 20/10/2003, reference number 350/2003 |
| Health condition(s) or problem(s) studied | Early arthritis with a symptom duration of less than four months |
| Intervention | Patients allocated to the corticosteroid group will receive one intramuscular injection of methyl-prednisolone (120 mg depot-formulation such as depomedrol or equivalent) at baseline. Patients allocated to the placebo group will receive one intramuscular injection with isotonic saline. Follow-up is for a maximum of one year. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methyl prednisolone |
| Primary outcome measure(s) |
The primary outcome will be the presence of clinical remission both at week 12 and at one year |
| Key secondary outcome measure(s) |
Secondary outcome measures include all core-set measures for clinical trials in rheumatoid arthritis (RA), as well as the use of NSAIDs and dosage |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Austria
- Lithuania
- Mexico
Study participating centre
Vienna Medical University
Vienna
A-1090
Austria
A-1090
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2010 | Yes | No | |
| Results article | results | 01/08/2013 | Yes | No |
