Arthritis, PsoriaticLAPIS-PsANCT03106051
Study of Apremilast Use in Patients With Psoriatic Arthritic in Practice Conditions
An observational study of Arthritis, Psoriatic, run by Amgen at 2 sites in Germany.
Trial summary
A total of approximately 500 patients with active psoriatic arthritis in an estimated 80 to 100 trial centers are to be enrolled. Selection of centers will be made by the sponsor's medical section. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic
- How many people
- 526 participants
- Where
- 2 sitesGermany
- Study dates
- 18 Feb 2016to 12 Aug 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Overall approx. 500 patients with active psoriatic arthritis are to be enrolled. Inclusion and exclusion criteria derive from the current Otezla® summary of product characteristics and the criteria.
Who may be able to join
- The decision to treat with Otezla® has been made independently before inclusion in this study
- Patient age ≥ 18 years
- Existing diagnosis of active psoriatic arthritis
- At least moderately severe psoriatic arthritis (Physician's Global Assessment (PGA) scale ≥ 2)
- Insufficient response or intolerance to previous Disease-Modifying Anti-Rheumatic Drug (DMARD) treatment (disease modifying anti-rheumatic drugs)
- A written informed consent statement by the patient permitting data collection, evaluation, storage and transfer
Who cannot join
- Pregnancy
- Hypersensitivity to apremilast or one of the other ingredients in the film tablets
- Other criteria according to the summary of product characteristics Breast-feeding
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Rheumatology at Struenseehaus
Altona, Free and Hanseatic City of Hamburg, 22767
Klinikum Stephansplatz
Hamburg, 20354
About this study
Official title: Long-term Documentation on the Use of Apremilast in Patients With Psoriatic Arthritis in Practice Conditions
A total of approximately 500 patients with active psoriatic arthritis in an estimated 80 to 100 trial centers are to be enrolled. Selection of centers will be made by the sponsor's medical section. To increase the quality of the data and to reduce distribution of the data collected, centers to be included will be those which can enroll at least 5 patients. Care will be taken to ensure a balanced regional distribution. The proposed observation period for the trial is approx. 52 weeks per patient. Estimated patient enrolment is also 52 weeks. The duration of the follow-up period will be extended from approx. 52 weeks to approx. 100 weeks to gain further information about the long-term use of Otezla®. For this extension of the follow-up period 2 new visits (visits 6 and 7) are proposed.Thus, proposed duration from first patient in (FPI) to last patient out (LPO) is 36 months-
- Conditions
- Arthritis, Psoriatic
- Keywords
- Arthritis, Psoriatic, Observational, Apremilast
- Medical subject headings
- Arthritis, Psoriatic, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with active psoriatic arthritis | Patients who suffer from active psoriatic arthritis with at least moderate disease corresponding to a PGA of ≥2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with an improvement of ≥ 1 points on the Physician's Global Assessment (PGA) scale on visit 3 compared to baseline on the Physician's Global Assessment scale (PGA; scale from 0-4)
Physician's global assessment (PGA) will be measured on a VAS scale ranging from 0 to 4. Primary endpoint is the percentage of patients with an improvement of minimum 1 point on this VAS scale after about 6 months (visit 3)
Measured: Up to approximately 7 months
Secondary outcomes (12)
Percentage of patients with an improvement of ≥ 1 points on the Patient Global Assessment (PaGA) scale on visits 1 to 7 compared to baseline
Patient Global Assessment will be measured on a VAS scale ranging from 0 to 5. The percentage of patients with an improvement of minimum 1 point will be measured throughout the study.
Measured: Up to approximately 104 weeks
Percentage of patients with an improvement of ≥ 1 points on the Physician's Global Assessment (PGA) scale on visits 1, 2, 4, 5, 6, 7 compared to baseline
Additionally to the primary endpoint the improvement of the PGA of minimum 1 point will be measured throughout the study.
Measured: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Tender Joint Count (TJC) on visits 1 to 7 compared to baseline
Tender Joint Count will be measured throughout the study and compared to baseline.
Measured: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Swollen Joint Count (SJC) on visits 1 to 7 compared to baseline
Swollen Joint Count will be measured throughout the study and compared to baseline.
Measured: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Pain
Visual Analog Scale; scale from 0-100 to question how the patient feels subjectively about their pain (0 = no pain, 100 = worst imaginable pain)
Measured: Up to approximately 104 weeks
Psoriatic arthritis Impact of Disease (PsAID) questionnaire on visits 1, 2, 3, 5 and 7 compared to baseline
Improvement of the Impact of Disease (PsAID) will be measured during visit 1, 2 and 5 and compared to baseline
Measured: Up to approximately 104 weeks
Hannover Functional Ability Questionnaire (FFbH) on visits 1, 2, 3, 5 and 7 compared to baseline
Composite score to measure functional improvement will be measured during visits 1, 2 and 5 and compared to baseline
Measured: Up to approximately 104 weeks
Patient Preference Questionnaire (PPQ) on visits 3, 5 and 7
The therapy preference of the patient will be measured compared to his previous systemic therapy
Measured: Up to approximately 104 weeks
Assessment of psoriatic skin changes (Body Surface Area, BSA) on visits 1 to 7
Extension of the psoriatic plaques will be measured by body surface area (BSA) throughout the study
Measured: Up to approximately 104 weeks
Adverse Events (AEs)
Number of subjects with adverse events
Measured: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Enthesitis
Visual Analog Scale; scale from 0-100 to question how the patient feels subjectively about their enthesitis (0 = no enthesitis, 100 = worst imaginable enthesitis)
Measured: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Joints
Visual Analog Scale; scale from 0-100 to question how the patient feels subjectively about their joints (0 = no affected joints, 100 = heavily affected joints)
Measured: Up to approximately 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start18 Feb 2016
- Primary completion31 Jul 2018
- Study completion12 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106051
- Sponsor's protocol ID
- CC-10004-PSA-008
- Acronym
- LAPIS-PsA
- Status last verified
- Sep 2025
- First submitted
- 17 Mar 2017
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Documentation on the Use of Apremilast in Patients With Psoriatic Arthritis in Practice Conditions
- ClinicalTrials.gov ID
- NCT03106051
- Acronym / sponsor ID
- LAPIS-PsA / CC-10004-PSA-008
- Conditions
- Arthritis, Psoriatic
- Keywords
- Arthritis, Psoriatic, Observational, Apremilast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 12 Aug 2020 (actual)
- First posted
- 10 Apr 2017 (actual)
- 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.
A total of approximately 500 patients with active psoriatic arthritis in an estimated 80 to 100 trial centers are to be enrolled. Selection of centers will be made by the sponsor's medical section. To increase the quality of the data and to reduce distribution of the data collected, centers to be included will be those which can enroll at least 5 patients. Care will be taken to ensure a balanced regional distribution. The proposed observation period for the trial is approx. 52 weeks per patient. Estimated patient enrolment is also 52 weeks. The duration of the follow-up period will be extended from approx. 52 weeks to approx. 100 weeks to gain further information about the long-term use of Otezla®. For this extension of the follow-up period 2 new visits (visits 6 and 7) are proposed.Thus, proposed duration from first patient in (FPI) to last patient out (LPO) is 36 months-
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with active psoriatic arthritis | – | –Patients who suffer from active psoriatic arthritis with at least moderate disease corresponding to a PGA of ≥2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Overall approx. 500 patients with active psoriatic arthritis are to be enrolled. Inclusion and exclusion criteria derive from the current Otezla® summary of product characteristics and the criteria.
Key inclusion criteria (6 listed)
- The decision to treat with Otezla® has been made independently before inclusion in this study
- Patient age ≥ 18 years
- Existing diagnosis of active psoriatic arthritis
- At least moderately severe psoriatic arthritis (Physician's Global Assessment (PGA) scale ≥ 2)
- Insufficient response or intolerance to previous Disease-Modifying Anti-Rheumatic Drug (DMARD) treatment (disease modifying anti-rheumatic drugs)
Key exclusion criteria (3 listed)
- Pregnancy
- Hypersensitivity to apremilast or one of the other ingredients in the film tablets
- Other criteria according to the summary of product characteristics Breast-feeding
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
Percentage of patients with an improvement of ≥ 1 points on the Physician's Global Assessment (PGA) scale on visit 3 compared to baseline on the Physician's Global Assessment scale (PGA; scale from 0-4)
Time frame: Up to approximately 7 months
Physician's global assessment (PGA) will be measured on a VAS scale ranging from 0 to 4. Primary endpoint is the percentage of patients with an improvement of minimum 1 point on this VAS scale after about 6 months (visit 3)
12 secondary outcomes
Percentage of patients with an improvement of ≥ 1 points on the Patient Global Assessment (PaGA) scale on visits 1 to 7 compared to baseline
Time frame: Up to approximately 104 weeks
Percentage of patients with an improvement of ≥ 1 points on the Physician's Global Assessment (PGA) scale on visits 1, 2, 4, 5, 6, 7 compared to baseline
Time frame: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Tender Joint Count (TJC) on visits 1 to 7 compared to baseline
Time frame: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Swollen Joint Count (SJC) on visits 1 to 7 compared to baseline
Time frame: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Pain
Time frame: Up to approximately 104 weeks
Psoriatic arthritis Impact of Disease (PsAID) questionnaire on visits 1, 2, 3, 5 and 7 compared to baseline
Time frame: Up to approximately 104 weeks
Hannover Functional Ability Questionnaire (FFbH) on visits 1, 2, 3, 5 and 7 compared to baseline
Time frame: Up to approximately 104 weeks
Patient Preference Questionnaire (PPQ) on visits 3, 5 and 7
Time frame: Up to approximately 104 weeks
Assessment of psoriatic skin changes (Body Surface Area, BSA) on visits 1 to 7
Time frame: Up to approximately 104 weeks
Adverse Events (AEs)
Time frame: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Enthesitis
Time frame: Up to approximately 104 weeks
Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Joints
Time frame: Up to approximately 104 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 3 Sep 2025.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Psoriatic, run by Amgen at 2 sites in Germany.
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 3 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 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
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?
Percentage of patients with an improvement of ≥ 1 points on the Physician's Global Assessment (PGA) scale on visit 3 compared to baseline on the Physician's Global Assessment scale (PGA; scale from 0-4) (time frame: Up to approximately 7 months). 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 3 Sep 2025.