Clinical Trial: A Study of the Real-life Management of Psoriatic Arthritis Patients Treated With Otezla® (Apremilast) in Belgium
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: An Observational Study of the Real-life Management of Psoriatic Arthritis Patients Treated With Otezla® (Apremilast) in Belgium
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.
Detailed Summary:
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 autho
Sponsor: Celgene
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
- 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.
- 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.
- 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.
- 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
- 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".
- 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
- 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).
- 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.
- 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
Original Secondary Outcome: Same as current
Information By: Celgene
Dates:
Date Received: March 24, 2017
Date Started: April 21, 2017
Date Completion: May 31, 2018
Last Updated: May 5, 2017
Last Verified: May 2017
