Psoriatic ArthritisPhase 4NCT00432406
Tumor Necrosis Factors (TNF)-α Blockade for Psoriatic Arthritis
A Phase 4 study testing Infliximab and Etanercept in people with Psoriatic Arthritis, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The purpose of this study is: To elucidate the immunomodulating properties of anti-TNF-α therapy in patients with psoriatic arthritis (PsA). To ascertain whether magnetic resonance imaging (MRI) is a sensitive tool in measuring early response after therapy with anti-TNF-α in the PsA wrist using the Outcome Measures in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Infliximab and Etanercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- May 2006to Mar 2009
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or above
- PsA with active disease despite treatment with non-steroidal anti-inflammatory drug (NSAID)
- 3 or more swollen and tender joints
- Inadequate response after 4 weeks of, or intolerance to nonsteroidal anti-inflammatory drug therapy.
- Methotrexate (MTX) is allowed during the study only if it has been taken for at least 3 months previously, with the dosage stable for at least 4 weeks prior to the baseline visit.
- Prednisone ≤ 10 mg/day and/or nonsteroidal anti-inflammatory drugs must have been taken at stable dosage for at least 2 weeks before entering the trial.
- Informed consent
Who cannot join
- Little or no ability for self-care
- Used a DMARD other than methotrexate or received intra-articular, intramuscular, or intravenous corticosteroids in the 4 weeks before screening.
- Topical vitamin A (Neotigason CR) or D analog preparations (Daivonex CR), and anthralin for psoriasis within 2 weeks of baseline.
- Concurrent treatment with MTX at dosages > 15 mg/week and/or corticosteroids in a prednisone-equivalent dosage of > 10 mg/day.
- Prior anti-TNF therapy at any time.
- Infected joint prosthesis during the previous 5 years.
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- Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months.
- Any chronic infectious disease such as renal infection, chest infection with bronchiectasis or sinusitis.
- Active tuberculosis requiring treatment within the previous 3 years.
- Opportunistic infections such as herpes zoster within the previous 2 months.
- Any evidence of active cytomegalovirus; active Pneumocystis carinii; or drug-resistant atypical mycobacterial infection.
- Known hypersensitivity to murine proteins
- Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
- A history of lymphoproliferative disease including lymphoma or signs suggestive of disease, such as lymphadenopathy of unusual size or location (ie, lymph nodes in the posterior triangle of the neck, infraclavicular epitrochlear, or periaortic areas); splenomegaly.
- Any known malignant disease except basal cell carcinoma currently or in the past 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TNF-α Blockade for Psoriatic Arthritis - A Clinical and MRI Study, and the Effects on Cytokine and Cardiovascular Risk Profile
The purpose of this study is:
- To elucidate the immunomodulating properties of anti-TNF-α therapy in patients with psoriatic arthritis (PsA).
- To ascertain whether magnetic resonance imaging (MRI) is a sensitive tool in measuring early response after therapy with anti-TNF-α in the PsA wrist using the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) guidelines for rheumatoid arthritis (RA).
- To assess whether the lipid and other cardiovascular risk profiles would improve after anti-TNF-α therapy in patients with PsA.
Read the detailed description
The study was a 12-week, open-label trial of anti-TNF therapy in 20 consecutive patients (Group 1). Another 20 consecutive patients with active disease whom have met the exclusion criteria, or were unwilling to start anti-TNF therapy for fear of toxicity would be recruited as control patients (Group 2). 20 healthy controls were recruited for comparison of the metabolic risk factors (Group 3). Study visits for groups 1 and 2 were conducted at baseline, weeks 2 and 6, and then week 12.
- Conditions
- Psoriatic Arthritis
- Being tested
- Infliximab, Etanercept
- Keywords
- Psoriatic Arthritis, TNF-α, Cardiovascular risk, Immunomodulatory activities
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called remicade
Infliximab 5 mg/kg given at day 1, week 2, week 6
EtanerceptDrug
Also called enbrel
Etanercept 25 mg twice weekly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | infliximab Receives: Drug: Infliximab |
| 2 | Active comparator | etanercept Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the degree of inflammation as reflected by the MRI score, cytokines and chemokine levels
Measured: week 52
Changes in the cardiovascular risk factor levels which are directly mediated by TNF-α
Measured: week 52
Secondary outcomes (2)
Number of patients who can achieve ACR 20
Measured: week 52
Correlation of clinical parameter, inflammatory markers and MRI findings
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study startMay 2006
- Primary completionMar 2009
- Study completionMar 2009
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 Chinese University of Hong KongThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Edmund K Li, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432406
- Sponsor's protocol ID
- PSA-2006-002
- Status last verified
- Mar 2009
- First submitted
- 6 Feb 2007
- Last updated
- 11 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TNF-α Blockade for Psoriatic Arthritis - A Clinical and MRI Study, and the Effects on Cytokine and Cardiovascular Risk Profile
- ClinicalTrials.gov ID
- NCT00432406
- Acronym / sponsor ID
- PSA-2006-002
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, TNF-α, Cardiovascular risk, Immunomodulatory activities
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 7 Feb 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.
The purpose of this study is:
- To elucidate the immunomodulating properties of anti-TNF-α therapy in patients with psoriatic arthritis (PsA).
- To ascertain whether magnetic resonance imaging (MRI) is a sensitive tool in measuring early response after therapy with anti-TNF-α in the PsA wrist using the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) guidelines for rheumatoid arthritis (RA).
- To assess whether the lipid and other cardiovascular risk profiles would improve after anti-TNF-α therapy in patients with PsA.
Detailed description
The study was a 12-week, open-label trial of anti-TNF therapy in 20 consecutive patients (Group 1). Another 20 consecutive patients with active disease whom have met the exclusion criteria, or were unwilling to start anti-TNF therapy for fear of toxicity would be recruited as control patients (Group 2). 20 healthy controls were recruited for comparison of the metabolic risk factors (Group 3). Study visits for groups 1 and 2 were conducted at baseline, weeks 2 and 6, and then week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Infliximabinfliximab |
| 2 | Active comparator | Drug: Etanerceptetanercept |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 or above
- PsA with active disease despite treatment with non-steroidal anti-inflammatory drug (NSAID)
- 3 or more swollen and tender joints
- Inadequate response after 4 weeks of, or intolerance to nonsteroidal anti-inflammatory drug therapy.
- Methotrexate (MTX) is allowed during the study only if it has been taken for at least 3 months previously, with the dosage stable for at least 4 weeks prior to the baseline visit.
Key exclusion criteria (15 listed)
- Little or no ability for self-care
- Used a DMARD other than methotrexate or received intra-articular, intramuscular, or intravenous corticosteroids in the 4 weeks before screening.
- Topical vitamin A (Neotigason CR) or D analog preparations (Daivonex CR), and anthralin for psoriasis within 2 weeks of baseline.
- Concurrent treatment with MTX at dosages > 15 mg/week and/or corticosteroids in a prednisone-equivalent dosage of > 10 mg/day.
- Prior anti-TNF therapy at any time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabAlso: remicadeInfliximab 5 mg/kg given at day 1, week 2, week 6 | Drug | 1 |
| EtanerceptAlso: enbrelEtanercept 25 mg twice weekly | Drug | 2 |
Primary outcome
Changes in the degree of inflammation as reflected by the MRI score, cytokines and chemokine levels
Time frame: week 52
Changes in the cardiovascular risk factor levels which are directly mediated by TNF-α
Time frame: week 52
2 secondary outcomes
Number of patients who can achieve ACR 20
Time frame: week 52
Correlation of clinical parameter, inflammatory markers and MRI findings
Time frame: week 52
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 11 Mar 2009.
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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.
Edmund K Li, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab and Etanercept in people with Psoriatic Arthritis, run by Chinese University of Hong Kong at 1 site in China.
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 7 inclusion and 15 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 11 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Changes in the degree of inflammation as reflected by the MRI score, cytokines and chemokine levels (time frame: week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 11 Mar 2009.