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

NCT03106051 | Completed

• 1 other identifier: CC-10004-PSA-008
• Study Type: observational
• Target: 526
• Locations: 1 country
• Sites: 2

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

Keywords

Arthritis; Psoriatic; Observational; Apremilast

Outcome Measures

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)

  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 Outcomes (12)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Patients with active psoriatic arthritis

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (2)

Rheumatology at Struenseehaus

Altona, Hamburg, 22767, Germany

Location

Klinikum Stephansplatz

Hamburg, 20354, Germany

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Arthritis, Psoriatic; Arthritis

Condition Hierarchy (Ancestors)

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

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: April 10, 2017
• Study Start: February 18, 2016
• Primary Completion: July 31, 2018
• Study Completion: August 12, 2020
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

DE (2)