Condition category
Musculoskeletal Diseases
Date applied
25/01/2007
Date assigned
26/02/2007
Last edited
02/10/2008
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 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

  1. 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.

Additional files

Editorial Notes