Apremilast in Psoriatic Arthritis in Real-life Clinical Practice in Greece

NCT03780504 | Unknown

• 1 other identifier: GEN-NIS-APR-002
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Following the evidence from the controlled clinical trial setting on the significant clinical benefits of apremilast in the treatment of active PsA, there is a scarcity of real-life evidence on the effectiveness and the beneficial role of apremilast in PsA in routine clinical practice. The present study primarily aims to generate real-world evidence on the impact of apremilast treatment on a broad population of biologic-naïve PsA patients in terms of its clinical effectiveness across the wide spectrum of disease manifestations, as well as its impact on disease burden and HRQoL, in the routine primary care settings of Greece.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• evaluate the apremilast impact on peripheral PsA disease activity

  Percentage of patients with active PsA treated with apremilast who will achieve at least 50% improvement in cDAPSA (clinical Disease Activity in Psoriatic Arthritis) baseline score at 24 weeks post-treatment onset

  at 24 weeks post-treatment onset

Secondary Outcomes (10)

• estimate the moderate cDAPSA response rate

  at 24 and 52 weeks post-treatment onset

• estimate the major cDAPSA response rate

  at 24 and 52 weeks post-treatment onset

• classify the study population into the PsA disease activity states

  at 52 weeks post-treatment onset

• evaluate the effect of apremilast treatment on enthesitis (complete resolution)

  at 16, 24 and 52 weeks post-treatment onset

• evaluate the effect of apremilast treatment on enthesitis (change in LEI score)

  at 16, 24 and 52 weeks post-treatment onset

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

The study population is adult biologic-naïve PsA patients, diagnosed with active peripheral PsA (as per physician's clinical judgement) who have had an inadequate response (to at least one DMARD and within the first 12 months of treatment) or who have been intolerant to a prior DMARD therapy, and who have prescribed treatment with apremilast according to the routine primary care settings of Greece.

You may qualify if:

• Male or female outpatients ≥18 years of age at the time of apremilast treatment onset;
• Patients diagnosed with active peripheral PsA (as per physician's clinical judgement) who have had an inadequate response (to at least one DMARD and within the first 12 months of treatment) or who have been intolerant to a prior DMARD therapy;
• Patients who have been prescribed treatment with apremilast (Otezla®) for PsA, either as a monotherapy or combination therapy with classical systemic DMARD, prior to signed Informed Consent and for whom, if treatment has started, no more than one week has elapsed from treatment initiation to obtaining the signed Informed Consent;
• Patients for whom the decision to prescribe therapy with apremilast according to the locally approved SmPC has already been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study;
• Patients with available information on the measures needed for the calculation of cDAPSA score at the start of apremilast treatment (i.e., number of swollen and tender joints based on the 66 swollen joint count and the 68 tender joint count, respectively, and patient global assessments of disease activity and pain);
• Patients must be able to read, understand and complete the study specific questionnaires;
• Patients must be able to understand the study procedures and adhere to the study visit schedule.

You may not qualify if:

• A patient who meets any of the following criteria will be excluded from participation in this study:
• Patients who have a history of exposure to biologic treatment and/or to tofacitinib in PsA;
• Patients that meet any of the contraindications to the administration of the apremilast as outlined in the latest version of the locally approved SmPC;
• Patients who currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the start of therapy with apremilast;
• Patients who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period.

Sponsors & Collaborators

• Genesis Pharma S.A.: lead
• Celgene: collaborator
• Amgen: collaborator

Study Sites (1)

Euromedica Private Clinic

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Nikos Antonakopoulos, MD

  Genesis Pharma S.A.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: April 15, 2019
• Primary Completion: July 20, 2021
• Study Completion: December 31, 2022
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)