Condition category
Musculoskeletal Diseases
Date applied
21/09/2010
Date assigned
25/10/2010
Last edited
25/10/2010
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

Prof Roberto Caporali

ORCID ID

Contact details

Piazzale Golgi 19
Pavia
27100
Italy
labreum@smatteo.pv.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

RAREmission

Study hypothesis

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 patient’s 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

Local Ethical Committee of the IRCCS Policlinico San Matteo Foundation of Pavia approved on the 8/05/2007 (ref: P-20070011051)

Study design

Open label randomised clinical trial with parallel design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Prednisone, methotrexate

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/01/2006

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

220

Participant exclusion criteria

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

Recruitment start date

01/01/2006

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Italy

Trial participating centre

Piazzale Golgi 19
Pavia
27100
Italy

Sponsor information

Organisation

IRCCS Policlinico San Matteo (Italy)

Sponsor details

Chair and Unit of Rheumatology
Reparti Speciali IV Floor
Piazzale Golgi 19
Pavia
27100
Italy
+39 (0)382 501878
scottir@unipv.it

Sponsor type

Not defined

Website

http://www.www.unipv.it

Funders

Funder type

University/education

Funder name

University of Pavia (Italy)

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

Publication citations

Additional files

Editorial Notes