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 |
| Protocol serial number | Prato/33 |
| Sponsor | Hospital of Prato (Italy) |
| Funder | Investigator-funded (Italy) |
- 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
Scientific
Hospital of Prato
2nd Division of Medicine and Rheumatology
Piazza Ospedale, 1
Prato
59100
Italy
| Phone | +39 (0)574 434572 |
|---|---|
| fcantini@usl4.toscana.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Case-control study |
| Secondary study design | Case-control study |
| Scientific title | |
| Study acronym | PSARE (PSoriatic Arthritis REmission) |
| Study objectives | 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(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) studied | Peripheral psoriatic arthritis |
| Intervention | Traditional DMARDs vs anti-TNF agents |
| Intervention type | Other |
| Primary outcome measure(s) |
Modified American College of Rheumatology (ACR) criteria for clinical remission |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 400 |
| Key inclusion criteria | Case patients: consecutive new outpatients with peripheral psoriatic arthritis requiring second-line drugs Controls: consecutive new outpatients with rheumatoid arthritis |
| Key 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. |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Italy
Study participating centre
Hospital of Prato
Prato
59100
Italy
59100
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
