Psoriatic ArthritisNCT00451243
Differential Clinical and Serologic Response in Psoriasis and Psoriatic Arthritis to Drug Treatment
An observational study of Psoriatic Arthritis, run by National Taiwan University Hospital.
Trial summary
Psoriasis is a multifactorial cutaneous disorders which affects about 100000 patients in Taiwan. Psoriatic arthritis is also present in about 20~30 percents. Many drugs have been shown to aggravate psoriasis including drugs used in the treatment of psoriatic arthritis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriatic Arthritis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jun 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of psoriasis
Who cannot join
None listed.
About this study
Official title: Differential Clinical and Serologic Response in Psoriasis and Psoriatic Arthritis to Drug Treatmen
Psoriasis is a multifactorial cutaneous disorders which affects about 100000 patients in Taiwan. Psoriatic arthritis is also present in about 20~30 percents. Many drugs have been shown to aggravate psoriasis including drugs used in the treatment of psoriatic arthritis. On the contrary, anti-psoriatic drugs are also known to aggravate or induce psoriatic arthritis. Psoriasis and psoriatic arthritis are believed to share the same pathogenic lymphocytes, but the differential responses to drugs are intriguing. This also causes problems in the treatment of psoriasis and psoriatic arthritis. Recently different serologic markers have been found for the assessment of psoriasis and psoriatic arthritis. Recent genetic study showed a different genetic susceptibility genes. We tested the serologic responses of three new biologic drugs used in the treatment of psoriasis and psoriatic arthritis. Paired blood samples of the same patients before and after 12 weeks of treatment were used. IL6 decreased after alefacept and etanercept but was increased after efalizumab treatment without statistical significance (Paired t test: 0.3336、0.2773、0.5904)。IL-8 decreased after etanercept but increased after efalizumab and alefacept without statistical significance (Paired t test: 0.4031、0.6749、0.2998)。IL10 decreased after efalizumab and etanercept, but increased significantly after alefacept treatment (Paired t test: 0.7254、0.5123、0.0350)。None of the treatment has a significant effect on TNF-alpha. HC10 decreased after alefacept and efalizumab,but increased after etanercept treatmentwithout statistical significance (Paired t test: 0.6589、0.1576、0.1988).
- Conditions
- Psoriatic Arthritis
- Keywords
- psoriatic arthritis
- Medical subject headings
- Arthritis, Psoriatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startJan 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- TSEN-FANG Tsai, Study chair, TSEN-FANG Tsai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451243
- Sponsor's protocol ID
- 9361701244
- Other IDs
- 9361701244
- Status last verified
- Dec 2004
- First submitted
- 22 Mar 2007
- Last updated
- 23 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Clinical and Serologic Response in Psoriasis and Psoriatic Arthritis to Drug Treatmen
- ClinicalTrials.gov ID
- NCT00451243
- Acronym / sponsor ID
- 9361701244
- Conditions
- Psoriatic Arthritis
- Keywords
- psoriatic arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jun 2005
- First posted
- 23 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psoriasis is a multifactorial cutaneous disorders which affects about 100000 patients in Taiwan. Psoriatic arthritis is also present in about 20~30 percents. Many drugs have been shown to aggravate psoriasis including drugs used in the treatment of psoriatic arthritis. On the contrary, anti-psoriatic drugs are also known to aggravate or induce psoriatic arthritis. Psoriasis and psoriatic arthritis are believed to share the same pathogenic lymphocytes, but the differential responses to drugs are intriguing. This also causes problems in the treatment of psoriasis and psoriatic arthritis. Recently different serologic markers have been found for the assessment of psoriasis and psoriatic arthritis. Recent genetic study showed a different genetic susceptibility genes. We tested the serologic responses of three new biologic drugs used in the treatment of psoriasis and psoriatic arthritis. Paired blood samples of the same patients before and after 12 weeks of treatment were used. IL6 decreased after alefacept and etanercept but was increased after efalizumab treatment without statistical significance (Paired t test: 0.3336、0.2773、0.5904)。IL-8 decreased after etanercept but increased after efalizumab and alefacept without statistical significance (Paired t test: 0.4031、0.6749、0.2998)。IL10 decreased after efalizumab and etanercept, but increased significantly after alefacept treatment (Paired t test: 0.7254、0.5123、0.0350)。None of the treatment has a significant effect on TNF-alpha. HC10 decreased after alefacept and efalizumab,but increased after etanercept treatmentwithout statistical significance (Paired t test: 0.6589、0.1576、0.1988).
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of psoriasis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TSEN-FANG Tsai study chair
TSEN-FANG Tsai
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2007.