Study of Apremilast Use in Patients With Psoriatic Arthritic in Practice Conditions

Arthritis, Psoriatic Clinical Trial

— LAPIS-PsA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106051
• Other study ID #: CC-10004-PSA-008
• Status: Completed
• Start date: February 18, 2016
• Est. completion date: August 12, 2020

Study information

• Verified date: August 2020
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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-

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: August 12, 2020
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Locations

Country	Name	City	State
Germany	Klinikum Stephansplatz	Hamburg
Germany	Rheumatology at Struenseehaus	Hamburg-Altona	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse Events (AEs)	Number of subjects with adverse events	Up to approximately 104 weeks
Secondary	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
Secondary	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

External Links

•   AmgenTrials clinical trials website