Clinical and ultrasonographic efficacy of low-dose prednisone co-treatment versus methotrexate alone in early rheumatoid arthritis

Clinical and ultrasonographic efficacy of low-dose prednisone co-treatment versus methotrexate alone in early rheumatoid arthritis: an open label randomised clinical trial with parallel design

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN24868111

Enrollment

220

Registered

2010-10-25

Start date

2006-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis

Interventions

Steroid arm: prednisone (Deltacortene) 12.5 mg/day for 2 weeks and then 6.25 mg + Methotrexate 10mg/week No steroid arm: Methotrexate 10mg/week. Drug escalation after 2-4-6-9 months for every group:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Fulfilment of the American College of Rheumatology (ACR) classification criteria for RA 2. Aged greater than 18 years, either sex 3. Symptom duration less than 12 months

Exclusion criteria

Exclusion criteria: Contraindications for glucocorticoid therapy, including uncontrolled diabetes and previous fragility osteoporotic fractures

Design outcomes

Primary

Measure	Time frame
1. Clinical remission (DAS<1.6), measured at 12 months 2. Ultrosonographic remission (PD=0), measured at 12 months	—

Secondary

Measure	Time frame
measured at 12 months: 1. Mean decrease in swollen joint count 2. Tender joint count 3. ESR 4. CRP 5. Power Doppler scores	—

Countries

Italy

Outcome results

None listed

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