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Prospective, controlled clinical study on the effect of 120 mg depot-methyl-prednisolone compared to placebo on the course of recent onset arthritis - Very early steroid therapy in arthritis - the "Stop Arthritis Very Early" (SAVE) trial

Prospective, controlled clinical study on the effect of 120 mg depot-methyl-prednisolone compared to placebo on the course of recent onset arthritis - Very early steroid therapy in arthritis - the "Stop Arthritis Very Early" (SAVE) trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000803-17-LT
Enrollment
400
Registered
2005-11-11
Start date
2006-01-06
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early undifferentiated arthritis

Interventions

Trade Name: Depo-Medrol Product Name: Depo-Medrol Pharmaceutical Form: Suspension for injection INN or Proposed INN: Methylprednisolone acetas Concentration unit: mg/ml milligram(s)/millilitre Concent

Sponsors

The SAVE trial group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible to the trial are newly referred patients with - arthritis of at least one joint (out of 66 possible joints), - a duration of symptoms of inflammatory arthritis of 16 weeks at most, - no pre-treatment with steroids for this indication - no pre-treatment with a coxib for this indication Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Excluded will be: - Patients under 18 yrs. - Patients with joint swelling due to trauma. - Patients with only DIP arthritis. - Patients with suspected or proven septic arthritis or gout. - Patients requiring oral anticoagulant therapy precluding i. m. injections - Patients who are pregnant. - Patients with a contraindication for Paracetamol o severe liver function failure (Child-Pugh >9) o significantly impaired kidney function (creatinine >1,8 mg/dl) o Gilbert-Meulengracht's syndrome - Patients with a contraindication for NSAIDs and/or coxibs: o a history of sulfonamide allergy o active gastric- or duodenal ulcer or gastrointestinal bleeding o a history of exacerbation of asthma, uticaria, or angioedema following NSAID- or aspirin intake. o severe liver function failure (Child-Pugh >9) o significantly impaired kidney function (creatinine >1,8 mg/dl) o severe heart failure

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate whether patients with recent onset arthritis have a higher chance to be in remission both at 12 weeks and after one year of follow-up, if treated with 120mg Methyl-Prednisolone as compared to a placebo-injection.;Secondary Objective: ;Primary end point(s): The primary outcome will be the presence of clinical remission both at week 12 and at 1year—

Countries

Lithuania

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026