Condition category
Musculoskeletal Diseases
Date applied
24/11/2005
Date assigned
10/03/2006
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes