Clinical and ultrasonographic efficacy of low-dose prednisone co-treatment versus methotrexate alone in early rheumatoid arthritis
| ISRCTN | ISRCTN24868111 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24868111 |
| Protocol serial number | N/A |
| Sponsor | IRCCS Policlinico San Matteo (Italy) |
| Funder | University of Pavia (Italy) |
- Submission date
- 21/09/2010
- Registration date
- 25/10/2010
- Last edited
- 25/10/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Roberto Caporali
Scientific
Scientific
Piazzale Golgi 19
Pavia
27100
Italy
| labreum@smatteo.pv.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open label randomised clinical trial with parallel design |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 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 |
| Study acronym | RAREmission |
| Study objectives | The use of corticosteroids (CS) in association with conventional disease modifying anti-rheumatic drugs (DMARDs) is strongly recommended in the treatment of rheumatoid arthritis (RA) and other rheumatic diseases after a careful evaluation of patients risk to benefit ratio. In particular in RA, CS show a rapid symptomatic effect on inflammatory symptoms (pain and general well-being) and help in controlling objective signs of inflammation (tender and swollen joints). Several studies also support disease modifying properties for CS, in terms of prevention of future joint damage in early RA, both for initial short-time high dosages followed by step down schedules and for low-dose oral therapy. On the whole, in clinical trials involving early-onset RA patients treated with low-dose oral CS in association with DMARDs, clinical and functional benefits last only few months after the start of treatment, fading away thereafter, whilst prevention of structural damage persists over a longer time. Thus, these studies on CS therapy in RA seem to point at the very same conclusion, suggesting a sort of dissociation between the short-term unsustained clinical response against the long lasting effect on radiographic progression. This might be due both to a partial dissociation between clinically detectable joint inflammation and structural damage, and to a deeper effect of CS in reducing synovial inflammation and subsequent joint destruction. Ultrasensitive imaging techniques may help in testing this hypotheses. Recent imaging studies on RA have demonstrated that the structural progression observed in patients in clinical remission might be explained by the persistency of a subclinical signs of synovitis detected by magnetic resonance imaging or ultrasonography (US). In particular, Power-Doppler ultrasonography (PDUS), which measures the amount of intrarticular blood flow, has been demonstrated to be a valid and reliable tool in detecting subclinical inflammation in RA, and it is believed to be an objective measure of activity of joint inflammation. However, only a few uncontrolled studies have tested the effect of CS on US-detected joint inflammation, showing rapid improvement of US-detected synovial inflammation after intra-articular and intravenous CS treatment in established RA. At present there is no evidence about the effect of low dose oral CS on the US-detected synovial inflammation. This study aimed to verify, in patients with recent-onset RA, the effect of low doses of oral prednisone on clinical and US outcomes over 12 months of follow-up. |
| Ethics approval(s) | Local Ethical Committee of the IRCCS Policlinico San Matteo Foundation of Pavia approved on the 8/05/2007 (ref: P-20070011051) |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | 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: MTX escalation to 15mg/week and to 20mg/week if lack of achievement of low-disease activity (DAS<2.4). |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Prednisone, methotrexate |
| Primary outcome measure(s) |
1. Clinical remission (DAS<1.6), measured at 12 months |
| Key secondary outcome measure(s) |
measured at 12 months: |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 220 |
| Key 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 |
| Key exclusion criteria | Contraindications for glucocorticoid therapy, including uncontrolled diabetes and previous fragility osteoporotic fractures |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Italy
Study participating centre
Piazzale Golgi 19
Pavia
27100
Italy
27100
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
