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

NCT ID: NCT03106051

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 526 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-18
• Study Completion Date: 2020-08-12

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-

Conditions

Arthritis, Psoriatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with active psoriatic arthritis

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Rheumatology at Struenseehaus

Altona, City state of Hamburg, Germany

Klinikum Stephansplatz

Hamburg, , Germany

Countries

Germany

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

CC-10004-PSA-008

Identifier Type: -

Identifier Source: org_study_id