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A Study of the Real-life Management of Psoriatic Arthritis Patients Treated With Otezla® (Apremilast) in Belgium (APOLO)

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ClinicalTrials.gov Identifier: NCT03096990
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
The study will include a representative sample of 150 patients with active Psoriatic Arthritis (PsA) for whom the treating rheumatologist has decided to begin treatment with apremilast. This study is non-interventional, drug dosing and treatment duration will be at the sole discretion of the treating rheumatologist, in accordance with the local label and daily clinical practice. APOLO is a national (Belgium), multicentre, prospective, non-interventional, post-marketing study.

Condition or disease Intervention/treatment
Arthritis, Psoriatic Drug: apremilast

Detailed Description:

Patient care will follow routine clinical practice, involving regular follow-up visits, without any mandatory visit. In daily practice, patients are usually seen by their treating rheumatologist every 3 months. In this study, patients will be followed-up for a least 6 months and at most 18 months after apremilast treatment initiation. Considering that Belgian National Institute for Health and Disability Insurance (NIHDI) queries have to be addressed by 31st January 2019, patient data will be collected until May/June 2018. Assuming a recruitment phase of 12-month duration starting as of December 2016, individual patient follow-up times will range from 6 to 18 months, depending on the inclusion date.

During the study, it is expected to collect data at inclusion and at 6 months after apremilast initiation in all patients. As per NIHDI recommendations, patients should consult their treating rheumatologists 6 months after apremilast initiation in order to evaluate treatment response and decide on treatment continuation for an additional period of 12 months. For patients recruited early in the study, data will be collected during the next follow-up visits up to 18 months after apremilast initiation. Only data pertaining to visits occurring at 9 (± 1), 12 (± 1), 15 (±1), and 18 (± 1) months after treatment initiation will be collected. If a study visit occurs approximately 3 (± 1) months after treatment initiation, the data will also be recorded.

All clinical data collected during this non-interventional study will be routinely documented in the patient's medical records, which are the main source of information. The study data will be collecting via an electronic Case Report Form (eCRF). Data from source documents including PRO-questionnaires will be entered in the eCRF by the investigator or other authorised appropriately designed and trained study site personnel. Data entered into the eCRF will be reviewed for consistency by the Data Manager using both automated logical checks (issuing in automatic queries generated by the system) and manual review (issuing in manual checks set by the Data Manager or the Monitor into the eCRF). All data collected within the eCRF will be approved and electronically signed and dated by the Investigator or designee. At the conclusion of the study, before the final statistical analysis, the eCRF and other study data will be locked to further additions or corrections.

During the study, the Clinical Research Associate (CRA) will contact each study site on a regular basis in order to check the progress and conduct of the study. If issues regarding study conduct arise, additional on-site visits may be performed. In particular, a quality analysis will also be performed and based on data quality, it will be decided whether on-site monitoring is necessary, for which site and on which percentage of patients. During monitoring visits, eCRFs, patient's source documents, and all other study documentation will be reviewed by the CRA. Accuracy will be checked by performing source data verification that is a direct comparison of the entries made onto the eCRF against the appropriate source documentation.

Adverse events AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) terminology.

The detailed methodology of the statistical analyses will be documented in a statistical analysis plan (SAP). The SAP will be written by the Clinical Research Organisation (CRO) in charge of the study and will be validated by sponsor prior to performing the analysis and obligatory before the database lock. A scientific committee has been selected for this study. This committee will provide advice on the SAP.


Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of the Real-life Management of Psoriatic Arthritis Patients Treated With Otezla® (Apremilast) in Belgium
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Apremilast

Group/Cohort Intervention/treatment
Use of apremilast in patients with active PsA
Psoriatic arthritis patients treated with Otezla® (apremilast) in Belgium
Drug: apremilast
Psoriatic arthritis patients treated with Otezla® (apremilast) in Belgium




Primary Outcome Measures :
  1. Proportion of patients showing response assessed by improvement for at least 2 out of 4 measures which compose the Psoriatic Arthritis Response Criteria (PsARC) at 6 months after apremilast initiation with respect to baseline [ Time Frame: 6 months after Apremilast initiation ]
    The PsARC tool is a composite response measure that has been specifically developed to assess response to treatment in Psoriatic Arthritis (PsA). PsARC is considered as an acceptable primary endpoint by the European Medicines Agency (EMA) The response for a given subject is defined by an improvement for at least 2 out of 4 measures which compose the PsARC (Patient Global Assessment [PtGA] of disease activity, Patient Global Assessment [PGA] of disease activity, 68-joint count for pain/tenderness and 66 joint count for swelling) and no worsening in any of the 4 measures.


Secondary Outcome Measures :
  1. Characteristics of the patients treated with apremilast [ Time Frame: Baseline ]
    The patients treated with Apremilast will be described according to the following characteristics: demographics (age, gender, weight, height, and ethnicity), professional status, lifestyle habits, medical history (including psoriasis and PsA treatment

  2. Change from baseline in measures which compose the PsARC (PtGA of disease activity, PGA of disease activity, 68-joint count for pain/tenderness, and 66-joint count for swelling) [ Time Frame: up to 18 months ]
    The PsARC tool is a composite response measure that has been specifically developed to assess response to treatment in PsA. PsARC is considered as an acceptable primary endpoint by the European Medicines Agency (EMA) The response for a given subject is defined by an improvement for at least 2 out of 4 measures which compose the PsARC (Patient Global Assessment [PtGA] of disease activity, Patient Global Assessment [PGA] of disease activity, 68-joint count for pain/tenderness and 66 joint count for swelling) and no worsening in any of the 4 measures.

  3. Change from Baseline in Psoriatic Arthritis Impact Of Disease 12 [PsAID12] score [ Time Frame: up to 18 months ]
    The total score is divided by 20 and the final score ranges from 0 to 10, where '10' represents the worst health score. PsAID 12 is a questionnaire assessing 12 domains (pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping, anxiety, embarrassment, social life, and depression) based on a 0-10 NRS, each parameter having a different coefficient.

  4. Change from Baseline in Health Assessment Questionnaire Disability Index [HAQ-DI] score [ Time Frame: up to 18 months ]
    The Health Assessment Questionnaire (HAQ) is a validated PRO questionnaire designed to measure health status and health-related quality of life. It consists of 20 items covering activities of daily living classified in 8 domains. Respondents indicate for every item whether they can do the activity 'without any difficulty', with 'some' or 'much difficulty' or are 'unable to do' the activity. The HAQ yields a disability index (HAQ-DI) score between 0 and 3, where, 0 means no functional disability and 3 represents severe functional disability.

  5. Change from Baseline in disease activity Numerical Rating Scale (NRS) [ Time Frame: up to 18 months ]

    Is an 11-point horizontal scale anchored at 0 and 10, with 0 representing "no disease activity" and 10 representing "maximal disease activity".

    The patient's global self-assessment of disease activity is measured on a 0 to 10 unit NRS. The physician's global assessment of disease activity is also measured on a 0 to 10 unit NRS. For patient's assessment and for the physician's assessment, the NRS


  6. Change from Baseline in pain/itch Visual Analogue Scale [VAS] [ Time Frame: up to 18 months ]
    The patient is asked to mark the line at the point that best represented the intensity of his or her pain and itch respectively. The VAS numeric values are the distances in millimeters from "no pain" and "no itch" respectively to the points marked by the patient. The pain VAS consists of a 100-mm horizontal line anchored at one end with the words "no pain" and at the other end with the words "worst possible pain".

  7. Change from Baseline in body surface area (BSA) [ Time Frame: up to 18 months ]
    The investigator evaluates the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb

  8. Change from Baseline in Leeds Enthesitis Index (LEI) [ Time Frame: up to 18 months ]
    The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site is then added to produce a total score (range 0 to 6).

  9. Change from Baseline in Dactylitis score [ Time Frame: up to 18 months ]
    Each digit on the hands and feet is rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Dactylitis is characterized by swelling of the entire finger or toe.

  10. Mean duration of treatment with apremilast in biologic-naïve patients and in patients having received a previous biological treatment. [ Time Frame: up to 18 months ]
    Time to the stop of the treatment by Apremilast will be calculated as the time interval from the date of apremilast initiation to the date of the apremilast stop

  11. Rate and reasons for discontinuation of apremilast treatment within 6 months after initiation [ Time Frame: Up to 6 months ]
    Descriptive statistics will be provided for the rate and reasons for discontinuation of treatment within 6 months. This analysis will be performed on safety population and restricted to patients who stop the treatment before the time point to analyse or for which the follow-up is at least so long as the time point to analyse.

  12. Adverse Events (AEs) [ Time Frame: up to 18 months ]
    Number of participants with adverse event



Information from the National Library of Medicine

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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
Adult patients with active PsA visiting rheumatology practices in Belgium and eligible for treatment with apremilast according to the local label and reimbursement criteria. The decision to treat the patient with apremilast will be made prior to the decision to enter the patient into the study.
Criteria

Inclusion Criteria:

- Patients who meet ALL the following criteria can be enrolled:

  • Male or female aged at least 18 years,
  • With a diagnosis of active Psoriatic Arthritis (PsA),
  • For whom the treating physician has made the decision to commence apremilast treatment in accordance with the local label and reimbursement criteria (refer to the reimbursement conditions mentioned in Section 1.2),
  • Able to follow the instructions of the study,
  • Having signed an Informed Consent Form (ICF).

Exclusion Criteria:

- Patients who meet AT LEAST one of the following exclusion criteria will be excluded:

  • Women who are pregnant, breastfeeding or planning on becoming pregnant,
  • Non-menopausal women who are not using an adequate contraception method,
  • Patients with hypersensitivity to apremilast or to one of its excipients.

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): NCT03096990


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

Locations
Belgium
ASZ Aalst Recruiting
Aalst, Belgium, 9300
Onze Lieve Vrouw Aalst Not yet recruiting
Aalst, Belgium, 9300
AZ Sint-Jan Not yet recruiting
Brugge, Belgium, 8000
CHU St Pierre (César de Paepe) Recruiting
Bruxelles, Belgium, 1000
Clinicque Saint-Jean Botanique Not yet recruiting
Bruxelles, Belgium, 1000
CHU Brugmann Not yet recruiting
Bruxelles, Belgium, 1020
Clin Univ de Bxl Hôpital Erasme Not yet recruiting
Bruxelles, Belgium, 1170
Cliniques Universiatires Saint-Luc Not yet recruiting
Bruxelles, Belgium, 1200
Private Practice Not yet recruiting
Céroux-Mousty, Belgium, 1341
UZ Antwerpen Not yet recruiting
Edegem, Belgium, 2650
Reumacentrum Genk Not yet recruiting
Genk, Belgium, 3600
Reumaclinic Recruiting
Genk, Belgium, 3600
UZ Gent Not yet recruiting
Gent, Belgium, 9000
GHdC Site Saint-Joseph Recruiting
Gilly, Belgium, 6060
CHU UCL Mont-Godinne Recruiting
Godinne, Belgium, 5530
Reuma Instituut Not yet recruiting
Hasselt, Belgium, 3500
AZ Zeno campus Knokke-Heist Not yet recruiting
Knokke-Heist, Belgium, 8300
UZ Leuven Gasthuisberg Recruiting
Leuven, Belgium, 3000
CHU Sart-Tilman Recruiting
Liège, Belgium, 4000
Reumatologie Medizorg Not yet recruiting
Merksem, Belgium, 2170
ZNA Jan Palfijn Recruiting
Merksem, Belgium, 2170
Private Practice Not yet recruiting
Uccle, Belgium, 1180
Sponsors and Collaborators
Celgene
Investigators
Study Director: Christophe Tessier, MD Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03096990     History of Changes
Other Study ID Numbers: CC-10004-PSA-010
U1111-1194-0305 ( Other Identifier: UTN Number )
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Psoriatic Arthritis
Observational
Otezla
Apremilast
Real-Life management
Belgium
APOLO
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