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

ISRCTN ISRCTN86668322
DOI https://doi.org/10.1186/ISRCTN86668322
EudraCT/CTIS number 2004-000803-17
Secondary identifying numbers Study protocol - version IX, EudraCT number 2004-000803-17
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

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
Email klaus.machold@meduniwien.ac.at

Study information

Study designRandomized placebo-controlled multicentre clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymSAVE
Study objectivesThe 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) studiedEarly arthritis with a symptom duration of less than four months
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Methyl prednisolone
Primary outcome measureThe primary outcome will be the presence of clinical remission both at week 12 and at one year
Secondary outcome measuresSecondary outcome measures include all core-set measures for clinical trials in rheumatoid arthritis (RA), as well as the use of NSAIDs and dosage
Overall study start date01/01/2004
Completion date01/07/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants400
Key inclusion criteriaNewly 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 criteria1. 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 enrolment01/01/2004
Date of final enrolment01/07/2007

Locations

Countries of recruitment

  • Austria
  • Lithuania
  • Mexico

Study participating centre

Vienna Medical University
Vienna
A-1090
Austria

Sponsor information

Vienna Medical University (Austria)
University/education

Vienna Medical University
Department of Internal Medicine III
Division of Rheumatology
Wahringer Gurtel 18-20
Vienna
1090
Austria

Phone +43 (0)140 400 4381
Email tanja.stamm@meduniwien.ac.at
ROR logo "ROR" https://ror.org/05n3x4p02

Funders

Funder type

Research organisation

European League Against Rheumatism (EULAR) grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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