Leflunomide or methotrexate plus subcutaneous tumour necrosis factor-alpha (TNF-alpha) blocking agents in rheumatoid arthritis
| ISRCTN | ISRCTN62900439 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62900439 |
| Secondary identifying numbers | N/A |
- Submission date
- 18/05/2010
- Registration date
- 06/07/2010
- Last edited
- 06/07/2010
- 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
Dr Maurizio Benucci
Scientific
Scientific
Ospedale S. Giovanni di Dio
ASL 10 Florence
via di Torregalli 3
Florence
50122
Italy
Study information
| Study design | Randomised open label active controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Local ethical committee of ASL10 Florence approved in 2005 (ref: CTS/2005/31057) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Etanercept, adalimumab, leflunomide, methotrexate |
| Primary outcome measure | 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 study start date | 05/05/2005 |
| Completion date | 20/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 96 undifferentiated Caucasian patients |
| Key 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 |
| Key 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) |
| Date of first enrolment | 05/05/2005 |
| Date of final enrolment | 20/09/2007 |
Locations
Countries of recruitment
- Italy
Study participating centre
Ospedale S. Giovanni di Dio
Florence
50122
Italy
50122
Italy
Sponsor information
St John of God Hospital (Ospedale S. Giovanni di Dio) (Italy)
Hospital/treatment centre
Hospital/treatment centre
ASL 10 Florence
via di Torregalli 3
Florence, Italy
50012
Italy
"ROR" |
https://ror.org/01c1ce922 |
|---|
Funders
Funder type
Hospital/treatment centre
St John of God Hospital (Ospedale S. Giovanni di Dio) (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
