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

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: Completed
• Conditions: Arthritis, Psoriatic

• Study Type: Observational
• Enrollment (Actual): 526

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

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)	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

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	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	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	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	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	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	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	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	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	Extension of the psoriatic plaques will be measured by body surface area (BSA) throughout the study	Up to approximately 104 weeks
Adverse Events (AEs)	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	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	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

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2016
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): August 12, 2020

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: September 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Arthritis; Observational; Apremilast; Psoriatic
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Skin and Connective Tissue Diseases; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: CC-10004-PSA-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No