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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT03106051

Collaborator

(none)

526

Enrollment

Locations

53.8

Actual Duration (Months)

263

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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-

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Psoriatic

Study Design

Study Type:

Observational

Actual Enrollment :

526 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 18, 2016

Actual Primary Completion Date :

Jul 31, 2018

Actual Study Completion Date :

Aug 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients with active psoriatic arthritis Patients who suffer from active psoriatic arthritis with at least moderate disease corresponding to a PGA of ≥2

Outcome Measures

Primary Outcome Measures

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) [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 Outcome Measures

Percentage of patients with an improvement of ≥ 1 points on the Patient Global Assessment (PaGA) scale on visits 1 to 7 compared to baseline [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.
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 [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.
Efficacy of the treatment with regard to rheumatic changes measured with Tender Joint Count (TJC) on visits 1 to 7 compared to baseline [Up to approximately 104 weeks]
Tender Joint Count will be measured throughout the study and compared to baseline.
Efficacy of the treatment with regard to rheumatic changes measured with Swollen Joint Count (SJC) on visits 1 to 7 compared to baseline [Up to approximately 104 weeks]
Swollen Joint Count will be measured throughout the study and compared to baseline.
Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Pain [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)
Psoriatic arthritis Impact of Disease (PsAID) questionnaire on visits 1, 2, 3, 5 and 7 compared to baseline [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
Hannover Functional Ability Questionnaire (FFbH) on visits 1, 2, 3, 5 and 7 compared to baseline [Up to approximately 104 weeks]
Composite score to measure functional improvement will be measured during visits 1, 2 and 5 and compared to baseline
Patient Preference Questionnaire (PPQ) on visits 3, 5 and 7 [Up to approximately 104 weeks]
The therapy preference of the patient will be measured compared to his previous systemic therapy
Assessment of psoriatic skin changes (Body Surface Area, BSA) on visits 1 to 7 [Up to approximately 104 weeks]
Extension of the psoriatic plaques will be measured by body surface area (BSA) throughout the study
Adverse Events (AEs) [Up to approximately 104 weeks]
Number of subjects with adverse events
Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Enthesitis [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)
Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Joints [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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