Contact information
Type
Scientific
Primary contact
Dr Klaus Machold
ORCID ID
Contact details
Vienna Medical University
Department of Internal Medicine III
Division of Rheumatology
Wahringer Gurtel 18-20
Vienna
A-1090
Austria
+43 (0)140 400 4381
klaus.machold@meduniwien.ac.at
Additional identifiers
EudraCT number
2004-000803-17
ClinicalTrials.gov number
Protocol/serial number
Study protocol - version IX, EudraCT number 2004-000803-17
Study information
Scientific title
Acronym
SAVE
Study hypothesis
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
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
Study design
Randomized placebo-controlled multicentre clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Methyl prednisolone
Primary outcome measures
The primary outcome will be the presence of clinical remission both at week 12 and at one year
Secondary outcome measures
Secondary outcome measures include all core-set measures for clinical trials in rheumatoid arthritis (RA), as well as the use of NSAIDs and dosage
Overall trial start date
01/01/2004
Overall trial end date
01/07/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant 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
Recruitment start date
01/01/2004
Recruitment end date
01/07/2007
Locations
Countries of recruitment
Lithuania, Mexico
Trial participating centre
Vienna Medical University
Vienna
A-1090
Austria
Sponsor information
Organisation
Vienna Medical University (Austria)
Sponsor details
Vienna Medical University
Department of Internal Medicine III
Division of Rheumatology
Wahringer Gurtel 18-20
Vienna
1090
Austria
+43 (0)140 400 4381
tanja.stamm@meduniwien.ac.at
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
European League Against Rheumatism (EULAR) grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20223838
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22984174
Publication citations
-
Results
Machold KP, Landewé R, Smolen JS, Stamm TA, van der Heijde DM, Verpoort KN, Brickmann K, Vázquez-Mellado J, Karateev DE, Breedveld FC, Emery P, Huizinga TW, The Stop Arthritis Very Early (SAVE) trial, an international multicentre, randomised, double-blind, placebo-controlled trial on glucocorticoids in very early arthritis., Ann. Rheum. Dis., 2010, 69, 3, 495-502, doi: 10.1136/ard.2009.122473.
-
Results
Biliavska I, Stamm TA, Martinez-Avila J, Huizinga TW, Landewé RB, Steiner G, Aletaha D, Smolen JS, Machold KP, Application of the 2010 ACR/EULAR classification criteria in patients with very early inflammatory arthritis: analysis of sensitivity, specificity and predictive values in the SAVE study cohort., Ann. Rheum. Dis., 2013, 72, 8, 1335-1341, doi: 10.1136/annrheumdis-2012-201909.