Psoriatic ArthritisPhase 4HUPSANCT01465438
HUmira in Psoriatic Arthritis
A Phase 4 study testing Adalimumab in people with Psoriatic Arthritis, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, which has a estimated prevalence of 0.3 - 1 %. The clinical course varies, but PsA is often a progressive, erosive arthritis causing severe disability and increased mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2006to Jun 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject Population: patients with active PsA, fulfilling the following major criteria:
- Diagnosis of PsA according to Moll and Wright criteria (Moll and Wright,
- Clinical active disease, defined as >2 (of 76) swollen joints and > 2 (of 78) tender joints
- Involvement of the hands (Clinical swelling of 1 or more finger joint and/or 1 or more 1 sausage finger)
- Clinical indication for anti-TNF alpha therapy, according to treating physician
- Among other issues: Age >18 years; adequate birth control; no contraindications for anti-TNF alpha-therapy, no previous anti-TNF alpha-therapy, no other significant dermatological disorders than psoriasis.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital, Glostrup
Glostrup Municipality, Copenhagen, 2600
About this study
Official title: Can New Imaging- and Biomarkers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Psoriatic Arthritis Patients Receiving Adalimumab?
Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, which has a estimated prevalence of 0.3 - 1 %. The clinical course varies, but PsA is often a progressive, erosive arthritis causing severe disability and increased mortality.
The biologic treatment infliximab and etanercept have recently been introduced for treatment of PsA and psoriasis, and current data indicate a higher efficacy than with previously available therapies. No clinical trials on adalimumab in PsA are yet published (2005), but preliminary data are encouraging. The improved treatment options have increased the need for sensitive methods for diagnosis, monitoring and prognostication of PsA, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Ultrasonography (US) and magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.
The hypothesis is that adalimumab will be an effective treatment option for PsA. Novel imaging- and biomarkers can provide additional information, compared to clinical measures and radiography, concerning activity, destructive progression and prediction of therapeutic response in PsA patients receiving adalimumab. The perspective is a potential improvement in diagnosis, monitoring and prognostication of patients with PsA.
- Conditions
- Psoriatic Arthritis
- Being tested
- Adalimumab
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira
Adalimumab 40 mg every other week
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | Responders at week 24 continue treatment with adalimumab. Non-responders at week 24 stops treatment with adalimumab. Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Psoriatic Arthritis Response criteria (PsARC)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startNov 2006
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Hvidovre
- Investigators
- Charlotte Wiell, MD, PhD, Study chair, University Hospital, Gentofte, CopenhagenInge Juul Sørensen, MD, PhD, Principal investigator, Copenhagen University Hospital, HvidovreMichael Sejer Hansen, MD, PhD, Principal investigator, Copenhagen University Hospital at HerlevOle Rintek Madsen, MD, PhD, Principal investigator, University Hospital, Gentofte, CopenhagenOle Slot, MD, Principal investigator, Glostrup University Hospital, CopenhagenSusanne J Pedersen, MD, Principal investigator, Gentofte University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465438
- Sponsor's protocol ID
- HUPSA HUM 05-040
- Other IDs
- 2006-000004-16
- Acronym
- HUPSA
- Status last verified
- Feb 2011
- First submitted
- 16 Jun 2011
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poggenborg RP, Wiell C, Boyesen P, Boonen A, Bird P, Pedersen SJ, Sorensen IJ, Madsen OR, Slot O, Moller JM, Hasselquist M, Kubassova O, Ostergaard M. No overall damage progression despite persistent inflammation in adalimumab-treated psoriatic arthritis patients: results from an investigator-initiated 48-week comparative magnetic resonance imaging, computed tomography and radiography trial. Rheumatology (Oxford). 2014 Apr;53(4):746-56. doi: 10.1093/rheumatology/ket426. Epub 2013 Dec 24.
PubMed 24369412
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can New Imaging- and Biomarkers Improve the Assessment of Disease Activity and Progression and Predict Therapeutic Outcome in Psoriatic Arthritis Patients Receiving Adalimumab?
- ClinicalTrials.gov ID
- NCT01465438
- Acronym / sponsor ID
- HUPSA / HUPSA HUM 05-040
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, Copenhagen University Hospital at Herlev, Copenhagen University Hospital, Hvidovre
- Study start
- Nov 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Nov 2011 (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.
Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, which has a estimated prevalence of 0.3 - 1 %. The clinical course varies, but PsA is often a progressive, erosive arthritis causing severe disability and increased mortality.
The biologic treatment infliximab and etanercept have recently been introduced for treatment of PsA and psoriasis, and current data indicate a higher efficacy than with previously available therapies. No clinical trials on adalimumab in PsA are yet published (2005), but preliminary data are encouraging. The improved treatment options have increased the need for sensitive methods for diagnosis, monitoring and prognostication of PsA, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Ultrasonography (US) and magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.
The hypothesis is that adalimumab will be an effective treatment option for PsA. Novel imaging- and biomarkers can provide additional information, compared to clinical measures and radiography, concerning activity, destructive progression and prediction of therapeutic response in PsA patients receiving adalimumab. The perspective is a potential improvement in diagnosis, monitoring and prognostication of patients with PsA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Drug: AdalimumabResponders at week 24 continue treatment with adalimumab. Non-responders at week 24 stops treatment with adalimumab. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of PsA according to Moll and Wright criteria (Moll and Wright,
- Clinical active disease, defined as >2 (of 76) swollen joints and > 2 (of 78) tender joints
- Involvement of the hands (Clinical swelling of 1 or more finger joint and/or 1 or more 1 sausage finger)
- Clinical indication for anti-TNF alpha therapy, according to treating physician
- Among other issues: Age >18 years; adequate birth control; no contraindications for anti-TNF alpha-therapy, no previous anti-TNF alpha-therapy, no other significant dermatological disorders than 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: HumiraAdalimumab 40 mg every other week | Drug | Adalimumab |
Primary outcome
Modified Psoriatic Arthritis Response criteria (PsARC)
Time frame: 24 weeks
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 4 Nov 2011.
- Derived from this study: PubMed 24369412Poggenborg RP, Wiell C, Boyesen P, Boonen A, Bird P, Pedersen SJ, Sorensen IJ, Madsen OR, Slot O, Moller JM, Hasselquist M, Kubassova O, Ostergaard M. No overall damage progression despite persistent inflammation in adalimumab-treated psoriatic arthritis patients: results from an investigator-initiated 48-week comparative magnetic resonance imaging, computed tomography and radiography trial. Rheumatology (Oxford). 2014 Apr;53(4):746-56. doi: 10.1093/rheumatology/ket426. Epub 2013 Dec 24.
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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.
Charlotte Wiell, MD, PhD study chair
University Hospital, Gentofte, Copenhagen
Inge Juul Sørensen, MD, PhD principal investigator
Copenhagen University Hospital, Hvidovre
Michael Sejer Hansen, MD, PhD principal investigator
Copenhagen University Hospital at Herlev
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 Adalimumab in people with Psoriatic Arthritis, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 6 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 4 Nov 2011. 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 Denmark. 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?
Modified Psoriatic Arthritis Response criteria (PsARC) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01465438, which also lists 1 linked publication.
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 4 Nov 2011.