Study of Apremilast Use in Patients With Psoriatic Arthritic in Practice Conditions (LAPIS-PsA)

September 1, 2025 updated by: Amgen

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-

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
526

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20354
        • Klinikum Stephansplatz
    • City state of Hamburg
      • Altona, City state of Hamburg, Germany, 22767
        • Rheumatology at Struenseehaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Up to approximately 7 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
Additionally to the primary endpoint the improvement of the PGA of minimum 1 point will be measured throughout the study.
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
Tender Joint Count will be measured throughout the study and compared to baseline.
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
Swollen Joint Count will be measured throughout the study and compared to baseline.
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
Visual Analog Scale; scale from 0-100 to question how the patient feels subjectively about their pain (0 = no pain, 100 = worst imaginable pain)
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
Improvement of the Impact of Disease (PsAID) will be measured during visit 1, 2 and 5 and compared to baseline
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
Composite score to measure functional improvement will be measured during visits 1, 2 and 5 and compared to baseline
Up to approximately 104 weeks
Patient Preference Questionnaire (PPQ) on visits 3, 5 and 7
Time Frame: Up to approximately 104 weeks
The therapy preference of the patient will be measured compared to his previous systemic therapy
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
Extension of the psoriatic plaques will be measured by body surface area (BSA) throughout the study
Up to approximately 104 weeks
Adverse Events (AEs)
Time Frame: Up to approximately 104 weeks
Number of subjects with adverse events
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
Visual Analog Scale; scale from 0-100 to question how the patient feels subjectively about their enthesitis (0 = no enthesitis, 100 = worst imaginable enthesitis)
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
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)
Up to approximately 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CC-10004-PSA-008

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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