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Completed

NCT Number: NCT03106051

Study of Apremilast Use in Patients With Psoriatic Arthritic 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-

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Key information

Conditions

Arthritis, Psoriatic Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rheumatology at Struenseehaus, Altona, Free and Hanseatic City of Hamburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

  10. Adverse Events (AEs)

    Time frame: Up to approximately 104 weeks

    Number of subjects with adverse events

  11. 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)

  12. 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)

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

Long-term Documentation on the Use of Apremilast in Patients With Psoriatic Arthritis in Practice Conditions

Acronym: LAPIS-PsA

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Apr 10, 2017
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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