Condition category
Musculoskeletal Diseases
Date applied
18/05/2010
Date assigned
06/07/2010
Last edited
06/07/2010
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

Dr Maurizio Benucci

ORCID ID

Contact details

Ospedale S. Giovanni di Dio
ASL 10 Florence
via di Torregalli 3
Florence
50122
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison between leflunomide or methotrexate plus subcutaneous tumour necrosis factor-alpha (TNF-alpha) blocking agents in rheumatoid arthritis: a two year open label study

Acronym

Study hypothesis

To compare the effectiveness and safety of a therapeutic regimen associating subcutaneous anti-tumour necrosis factor-alpha (anti-TNF-alpha) agents etanercept (ETN) and adalimumab (ADA) with leflunomide (LEF) or methotrexate (MTX), in a two year open-label study performed in clinical practice.

Background information:
New biological disease-modifying antirheumatic drugs (DMARDs) became available in 1999, including agents targeting anti-TNF-alpha agents. Among these, infliximab (INF), etanercept (ETN) and adalimumab (ADA) have been shown to reduce signs and symptoms of RA and to protect joints from structural damage in double-blind placebo-controlled randomised trials. Certain anti-TNF-alpha agents can be prescribed alone, but randomised trials have consistently demonstrated that the efficacy of these biological agents is significantly increased by concomitant MTX. However, not all patients tolerate or respond to MTX, and anti-TNF-alpha agents are commonly prescribed with DMARDs other than MTX in clinical routine.

Ethics approval

Local ethical committee of ASL10 Florence approved in 2005 (ref: CTS/2005/31057)

Study design

Randomised open label active controlled trial

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 (RA)

Intervention

Leflunomide 20 mg/ day or methotrexate 10-15 mg/ once week plus etanercept 50 mg /once week or adalimumab 14 mg/ every other week.
Total duration 104 weeks.

Intervention type

Drug

Phase

Phase IV

Drug names

Etanercept, adalimumab, leflunomide, methotrexate

Primary outcome measures

All patients were assessed at the beginning of the study (baseline) and every 3 months for 2 years by measuring 28-item Disease Activity Scale (DAS-28) score and DAS-CRP score. Remission was considered for a value less than 2.6 while low disease activity was considered for a value between 2.6 and 3.2.

Secondary outcome measures

Effectiveness and safety of both groups assessed using the value of DAS 28 and DAS-CRP score every 6 months.

Overall trial start date

05/05/2005

Overall trial end date

20/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (aged between 26 and 86 years, either sex) with active rheumatoid arthritis (RA) defined as follows: greater than or equal to 6 swollen joints and greater than or equal to 6 painful joints and at least two of the following:
1.1. Morning stiffness greater than or equal to 45 minutes
1.2. Erythrocyte sedimentation rate (ESR) greater than or equal to 28 mm/first hour
1.3. C-reactive protein (CRP) greater than or equal to 2.0 mg/dL
2. Stabilised low-dose of prednisone (less than or equal to 7.5 mg )
3. Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs)
4. Intrarticular injections of corticosteroids not allowed

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

96 undifferentiated Caucasian patients

Participant exclusion criteria

Patients in stable therapy with LEF or MTX with a non-controlled disease activity with association therapy using a biological infusion (infliximab, rituximab, abatacept) or with a high dose of prednisone (greater than 10 mg)

Recruitment start date

05/05/2005

Recruitment end date

20/09/2007

Locations

Countries of recruitment

Italy

Trial participating centre

Ospedale S. Giovanni di Dio
Florence
50122
Italy

Sponsor information

Organisation

St John of God Hospital (Ospedale S. Giovanni di Dio) (Italy)

Sponsor details

ASL 10 Florence
via di Torregalli 3
Florence
Italy
50012
Italy

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

St John of God Hospital (Ospedale S. Giovanni di Dio) (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