NCT02875184

Brief Summary

This is a multicenter, prospective, non-interventional, observational single arm study. 100 patients will be recruited in the Netherlands over a one year period. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into this study. Treatment will be according to routine clinical practice and based on recommendations as per the Summary of Product Characteristics (SPC) of apremilast (Otezla®). Each patient will be followed up for a maximum of 24 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

March 6, 2017

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

5.3 years

First QC Date

August 18, 2016

Last Update Submit

October 9, 2023

Conditions

Arthritis, Psoriatic

Keywords

Psoriatic ArthritisApremilastCC-10004

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with a Health Assessment Questionnaire - Disability Index (HAQ-DI) score of ≤ 0.5 or with a decrease of ≥ 0.3 of the HAQ-DI score compared with baseline

    The HAQ is a general questionnaire to assess physical functioning.

    Up to 24 months

Secondary Outcomes (7)

  • Change from Baseline in Psoriatic Arthritis Impact of Disease (PsAID) at various time point

    Up to 24 months

  • Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points

    Up to 24 months

  • Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at month 6

    Up to 6 months

  • Change from Baseline in Dermatology Life Quality Index (DLQI) at month 6

    Up to 6 months

  • Change from Baseline in Short Form 36 (SF36) at 12 months

    Up to 12 months

  • +2 more secondary outcomes

Study Arms (1)

Psoriatic arthritis patients treated with apremilast

Psoriatic arthritis patients who are treated with apremilast according to daily practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Two hundred adult patients treated with apremilast for psoriatic arthritis will be recruited. In all cases, the decision to treat the patient with apremilast will be made prior to the decision to enter the subject into the study.

You may not qualify if:

  • Refusal to participate in the study.
  • Language barrier for completing the questionnaires.
  • Women who are pregnant or breast-feeding.
  • Hypersensitivity to the active substance or to any of the excipients.
  • Prior exposure to apremilast
  • Initiation of apremilast treatment by a dermatologist for psoriasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Reumazorg ZWN

Lelystad/Emmeloord, Flevoland, 8233GT / 8303 BX, Netherlands

Location

St. Jansdal

Harderwijk, Gelderland, 3844DG, Netherlands

Location

Viecuri Medisch Centrum

Venlo, Limburg, 5912 BL, Netherlands

Location

Amphia

Breda, North Brabant, 4819 EV, Netherlands

Location

Elkerliek ziekenhuis

Helmond, North Brabant, 5707 HA, Netherlands

Location

Reumazorg ZWN

Roosendaal, North Brabant, 4707 CH, Netherlands

Location

MC Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

Location

Beatrix Ziekenhuis

Gorinchem, South Holland, 4204 AA, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, South Holland, 2803 HH, Netherlands

Location

Erasmus MC

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, South Holland, 3079 DZ, Netherlands

Location

Reumazorg ZWN

Goes, Zeeland, 4462 EV, Netherlands

Location

Research Site

Breda, 4818 CK, Netherlands

Location

Research Site

Gorinchem, 4204 AA, Netherlands

Location

Research Site

Gouda, 2803 HH, Netherlands

Location

Research Site

Harderwijk, 3844 DG, Netherlands

Location

Research Site

Leeuwarden, 8934 AD, Netherlands

Location

Research Site

Roosendaal, 4707 CH, Netherlands

Location

Research Site

Rotterdam, 3015 CE, Netherlands

Location

Research Site

Rotterdam, 3079 DZ, Netherlands

Location

Research Site

Venlo, 5912 BL, Netherlands

Location

Related Links

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin 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

August 18, 2016

First Posted

August 23, 2016

Study Start

March 6, 2017

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

NL(21)