Contact information
Type
Scientific
Primary contact
Dr Fabrizio Cantini
ORCID ID
Contact details
Hospital of Prato
2nd Division of Medicine and Rheumatology
Piazza Ospedale
1
Prato
59100
Italy
+39 (0)574 434572
fcantini@usl4.toscana.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Prato/33
Study information
Scientific title
Acronym
PSARE (PSoriatic Arthritis REmission)
Study hypothesis
Studies on the efficacy of traditional Disease-Modifying Anti-Rheumatic Drugs (DMARDs) in the treatment of Psoriatic Arthritis (PsA) show a significant efficacy compared to placebo, with a response ratio ranging from 20% to 50% of the patients. Better results have been obtained with leflunomide and anti-tumor necrosis factor drugs (anti-TNFα), with a response rate of 50%-70%. Similarly to rheumatoid arthritis (RA), response to therapy in PsA is usually measured in terms of percentage improvement with respect to baseline, but rarely patients have been evaluated for clinical remission. Moreover, differently from RA, remission criteria for PsA have not yet been defined. However, in keeping with other authors, over 15 years of activity of our rheumatologic centre, we noted PsA patients who experienced prolonged remission both during treatment and after therapy interruption. We designed a prospective, follow-up, case-control study to evaluate the frequency of clinical remission in patients with peripheral PsA, and the duration of remission episodes both during treatment and over the off-therapy follow-up period.
Ethics approval
Traditional DMARDs and all treatments employed in the study had the Italian Ministry of Health approval for PsA patients when the trial started in 2000. The trial obtained an automated approval from the Ethical Committee of the Hospital of Prato.
Study design
Case-control study
Primary study design
Interventional
Secondary study design
Case-control study
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Peripheral psoriatic arthritis
Intervention
Traditional DMARDs vs anti-TNF agents
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Modified American College of Rheumatology (ACR) criteria for clinical remission
Secondary outcome measures
Duration of clinical remission during treatment and after therapy interruption, to evaluate the ACR 20, 50, 70 response rates at the end of follow up, and to evaluate the correlation between initial clinical and laboratory variables and the frequency of remissions.
Overall trial start date
01/01/2000
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Case patients: consecutive new outpatients with peripheral psoriatic arthritis requiring second-line drugs
Controls: consecutive new outpatients with rheumatoid arthritis
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
400
Participant exclusion criteria
Patients with inflammatory spinal pain at presentation or during the disease course, or meeting the modified New York criteria for ankylosing spondylitis, and those with contraindications to the use of traditional DMARDs and anti-TNFα drugs.
Recruitment start date
01/01/2000
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Italy
Trial participating centre
Hospital of Prato
Prato
59100
Italy
Sponsor information
Organisation
Hospital of Prato (Italy)
Sponsor details
(c/o Dr Fabrizio Cantini)
2nd Division of Medicine and Rheumatology
Hospital of Prato
Piazza Ospedale,1
Prato
59100
Italy
+39 (0)574 434572
fcantini@usl4.toscana.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator-funded (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
2008 results on http://www.ncbi.nlm.nih.gov/pubmed/18400836
Publication citations
-
Results
Cantini F, Niccoli L, Nannini C, Cassarà E, Pasquetti P, Olivieri I, Salvarani C, Frequency and duration of clinical remission in patients with peripheral psoriatic arthritis requiring second-line drugs., Rheumatology (Oxford), 2008, 47, 6, 872-876, doi: 10.1093/rheumatology/ken059.