Frequency and duration of clinical remission in patients with peripheral psoriatic arthritis requiring second-line drugs. A 6-year, case-control study.

ISRCTN ISRCTN45507228
DOI https://doi.org/10.1186/ISRCTN45507228
Secondary identifying numbers Prato/33
Submission date
25/01/2007
Registration date
26/02/2007
Last edited
02/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Fabrizio Cantini
Scientific

Hospital of Prato
2nd Division of Medicine and Rheumatology
Piazza Ospedale, 1
Prato
59100
Italy

Phone +39 (0)574 434572
Email fcantini@usl4.toscana.it

Study information

Study designCase-control study
Primary study designInterventional
Secondary study designCase-control study
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymPSARE (PSoriatic Arthritis REmission)
Study objectivesStudies 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(s)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.
Health condition(s) or problem(s) studiedPeripheral psoriatic arthritis
InterventionTraditional DMARDs vs anti-TNF agents
Intervention typeOther
Primary outcome measureModified American College of Rheumatology (ACR) criteria for clinical remission
Secondary outcome measuresDuration 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 study start date01/01/2000
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants400
Key inclusion criteriaCase patients: consecutive new outpatients with peripheral psoriatic arthritis requiring second-line drugs
Controls: consecutive new outpatients with rheumatoid arthritis
Key exclusion criteriaPatients 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.
Date of first enrolment01/01/2000
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Italy

Study participating centre

Hospital of Prato
Prato
59100
Italy

Sponsor information

Hospital of Prato (Italy)
Hospital/treatment centre

(c/o Dr Fabrizio Cantini)
2nd Division of Medicine and Rheumatology
Hospital of Prato
Piazza Ospedale,1
Prato
59100
Italy

Phone +39 (0)574 434572
Email fcantini@usl4.toscana.it
ROR logo "ROR" https://ror.org/03gbp6p96

Funders

Funder type

Other

Investigator-funded (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2008 Yes No