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A Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands (REWARD)

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ClinicalTrials.gov Identifier: NCT02875184
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

This is a multicenter, prospective, non-interventional, observational single arm study.

Two-hundred 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.


Condition or disease
Arthritis, Psoriatic

Detailed Description:
The objective of this non-interventional study is to describe patient reported outcomes, effectiveness and real-life use of apremilast treatment in patients with psoriatic arthritis (PsA).

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Apremilast Use and Effectiveness in Patients With Psoriatic Arthritis in The Netherlands
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Apremilast

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



Primary Outcome Measures :
  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 [ Time Frame: Up to 24 months ]
    The HAQ is a general questionnaire to assess physical functioning.


Secondary Outcome Measures :
  1. Change from Baseline in Psoriatic Arthritis Impact of Disease (PsAID) at various time point [ Time Frame: Up to 24 months ]
    PsAID is a general questionnaire that measures the health impact of psoriatic arthritis.

  2. Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) at various time points [ Time Frame: Up to 24 months ]
    The TSQM questionnaire is a general measure of treatment satisfaction across medication types and patient conditions.

  3. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at month 6 [ Time Frame: Up to 6 months ]
    The BASDAI is used for measuring and evaluating disease activity in Ankylosing Spondylitis.

  4. Change from Baseline in Dermatology Life Quality Index (DLQI) at month 6 [ Time Frame: Up to 6 months ]
    The DLQI is a dermatology specific Quality of Life instrument.

  5. Change from Baseline in Short Form 36 (SF36) at 12 months [ Time Frame: Up to 12 months ]
    The SF-36v2® Health Survey measures functional health and well-being from the patients point of view. It can be used across age (18 and older), disease and treatments.

  6. Change from Baseline in EuroQol-5 dimensions (EQ5D) at 12 months [ Time Frame: Up to 12 months ]
    EQ-5D is a standard instrument to measure of health status.

  7. Change from Baseline in visual analogue scales (VAS) at various time point [ Time Frame: Up to 24 months ]
    VAS is a simple assessment of the global health, itch and pain severity using a visual analogue scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criter

  • Patients ≥ 18 years of age who understand and voluntarily sign an informed consent form.
  • Patients starting treatment with apremilast for psoriatic arthritis.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875184


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Netherlands
Viecuri Medisch Centrum Recruiting
Venlo, Limburg, Netherlands, 5912 BL
Reumazorg ZWN Recruiting
Roosendaal, Noord-Brabant, Netherlands, 4707 CH
Amphia Recruiting
Breda, North-Brabant, Netherlands, 4819 EV
Elkerliek ziekenhuis Recruiting
Helmond, North-Brabant, Netherlands, 5707 HA
Erasmus MC Recruiting
Rotterdam, South-Holland, Netherlands, 3015 CE
Maasstad Ziekenhuis Recruiting
Rotterdam, South-Holland, Netherlands, 3079 DZ
Sponsors and Collaborators
Celgene
Investigators
Study Director: Jan Pander, PhD Celgene B.V

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02875184     History of Changes
Other Study ID Numbers: CC-10004-PSA-009
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Keywords provided by Celgene:
Psoriatic Arthritis
Apremilast
CC-10004

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances