Arthritis, Psoriatic
Conditions
Brief summary
This observational study aims to assess the 1-year persistence of guselkumab in adult patients with psoriatic arthritis (an inflammatory disease that affects the joints in participants with psoriasis, a skin condition that causes red, scaly patches).
Interventions
None listed
Sponsors
Janssen-Cilag Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a confirmed diagnosis of psoriatic arthritis (PsA) as determined by a rheumatologist with reference to ClASsification criteria for Psoriatic ARthritis (CASPAR) * Start guselkumab as a first, second, third, or fourth line of disease-modifying antirheumatic drug (bDMARD) therapy for the indication of PsA as part of standard clinical practice at the time of enrollment into the observational study * Initiating guselkumab treatment according to Summary of Product Characteristics (SmPC) indication * The treatment decision must be taken by the participating rheumatologist prior to, and independently of the patient's inclusion into the study, following clinical practice in accordance with local and overarching guidelines and local regulations * Must have received the information note, given his/her oral agreement and has not objected to the collection of his/her data in accordance with French requirements
Exclusion criteria
* Have already taken a specific interleukin-23 inhibitor (IL-23i) treatment. * Are receiving combination therapy: 2 or more targeted therapies (biotherapy, Janus kinase \[JAK\] inhibitor, phosphodiesterase 4 (PDE4) inhibitor) indicated for PsA/PsO at the same time * Has a contra-indication to guselkumab according to the SmPC (for hypersensitivity or due to active clinically important infection, example active tuberculosis) * Unwilling or unable to participate in long-term data collection * Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study ( that is, signing of informed consent) * Currently enrolled in any interventional study or any Janssen-Cilag France-sponsored observational clinical study * Is under guardianship or curatorship, judicial protection, future protection mandate or under family authorization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Still Receiving Treatment at Persistence Time | Up to 8 weeks | Persistence time of the initial treatment: defined as the time from the date of the first administration of guselkumab to the date that the last dose of guselkumab treatment was administered plus 1 dosing interval (8 weeks), or until start of subsequent treatment. |
| Number of Participants Starting New Treatment | At 1 year | Participants starting new treatment along with reason of discontinuation will be reported. |
| Proportion of Participants Still Receiving Treatment at 1 Year | At 1 year | Discontinuation or maintenance of guselkumab treatment will be recorded by the physician at each visit. Proportion of participants still receiving treatment will be reported in the outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Still Receiving Treatment at 2 years | At 2 years | Percentage of participants still receiving treatment at 2 years will be reported. |
| Percentage of Participants Discontinuing The Treatment | At 2 years | Participants discontinuing the treatment along with the reasons will be reported. |
| Number of Participants Switching to New Treatment in Case of Discontinuation of Guselkumab Treatment | At Months 0, 3, 6, 12, 18 and 24 | Participants switching to new treatment in case of discontinuation of guselkumab treatment will be reported. |
| Change From Baseline in Disease Activity Index in Psoriatic Arthritis (DAPSA)/ Clinical Disease Activity Index in Psoriatic Arthritis (cDAPSA) | Baseline, Months 3,6,12,18, and 24 | The DAPSA was developed to characterize psoriatic arthritis (PsA) disease activity. It considers the number of painful and swollen joints, the patient's assessment of their disease and the C-reactive protein (CRP) measurement for acute inflammation. Where CRP measurements are not available, the clinical DAPSA (cDAPSA) maybe be used, which omits CRP. An overall score is calculated, where higher scores correspond to higher disease activity. Cut-off values for DAPSA low and high disease activity are: ≤14 and \>28 points, respectively, and for remission is ≤4 points. The cut-off values for cDAPSA are: ≤4 points for remission, \>4 to ≤13 points for low disease activity, \> 13 to ≤27 points for moderate disease activity, and \>27 points for high disease activity. |
| Change From Baseline in Leeds Enthesitis Index (LEI) Score | Baseline, Months 3,6,12,18, and 24 | The Leeds enthesitis index (LEI) measures the activity of enthesitis in PsA. The index measures the severity and activity of enthesitis, inflammation at the attachment of the ligaments and tendons to bone. The clinical assessor must elicit tenderness at 6 enthesitis sites: both lateral epicondyles of the humerus, both medial condyles of the femur, and the Achilles tendon insertions. Each site affected is summed to give a score out of 6, where 6 indicates all sites affected. |
| Change From Baseline in Back and Neck Pain Numerical Rating Scale (NRS) Score | Baseline, Months 3,6,12,18, and 24 | NRS for back and neck pain will be administered. This is a simple numbered 0-10 scale on which the patient indicates the intensity of their pain (0 represents no pain and 10 indicates the worst possible pain). |
| Hazard Ratios Between Baseline Clinical Factors and Guselkumab Persistence and Effectiveness at Months 12 and 24 | At Month 12 and 24 | Hazard ratios for association between baseline clinical factors and persistence/effectiveness from Cox proportional hazards models will be reported. |
| Sociodemographic Characteristics: Age | At Baseline | Participant's age will be reported. |
| Sociodemographic Characteristics: Sex | At Baseline | Participant's sex (male, female) will be reported |
| Sociodemographic Characteristics: Weight | At Baseline | Participant's weight will be reported |
| Sociodemographic Characteristics: Height | At Baseline | Participant's height will be reported. |
| Sociodemographic Characteristics: Body Mass Index (BMI) | At Baseline | Participant's BMI will be reported. |
| Number of Participants Reporting Smoking, Cannabis and Alcohol Use | At Baseline | Participant's smoking, use of Cannabis and Alcohol habit will be reported. |
| Number of Participants With Family History of Psoriasis and/or Psoriatic Arthritis and/or Spondyloarthritis | At Baseline | Family history of psoriasis and/or psoriatic arthritis and/or spondyloarthritis wil be reported. |
| Date of Diagnosis of Psoriatic Arthritis | At Baseline | Date of diagnosis of psoriatic arthritis will be reported. |
| Date of Previous Treatments of Psoriatic Arthritis | At Baseline | Date of previous treatments of psoriatic arthritis will be reported. |
| Duration of Previous Treatments of Psoriatic Arthritis | At Baseline | Duration of previous treatments of psoriatic arthritis will be reported. |
| Medical History and Current Situation | At Baseline | Participants medical history and current medical situation will be reported. |
| Number of Participants Receiving Co-occurring Treatments Linked to Psoriatic Arthritis | Baseline up to 2 Years | Participants receiving co-occurring treatments linked to psoriatic arthritis at baseline and during follow-up will be reported. |
| Failure to Achieve or Maintain Response | Up to 2 Years | Failure to achieve or maintain response to at least 2 biologic/targeted synthetic DMARDs with at least 2 different mechanisms of action (Y/N) (For treatment refractory criteria). |
| Number of Participants Reporting Problems Related to the Management of Signs and Symptoms | At baseline | The management of signs and/or symptoms that is perceived as problematic by the rheumatologist and/or the participants will be reported. |
| Evidence of Persistent Disease | Up to 2 Years | Evidence of persistent disease as defined by at least 2 of the following: a) failure to achieve or maintain low disease activity, b) the presence of active extra-musculoskeletal manifestations of PsA, c) objective evidence of inflammatory activity, namely clinical signs, elevated acute phase reactants and/or imaging findings suggestive of inflammation. |
| Number of Participants with Co-Morbidities | At baseline | Number of participants with co-morbidities will be reported. |
| Number of Participants with Abnormal Psychosocial Factors | At Baseline | Number of participants with abnormal psychosocial factors will be reported. |
| Healthcare Professional (HCP): Age Group | At Baseline | Age group of HCP will be reported. |
| HCP: Sex | At Baseline | Sex of HCP will be reported. |
| HCP: Experience | At Baseline | Experience of HCP will be reported. |
| HCP: Type of Practice | At Baseline | Type of practice of HCP will be reported. |
| Number of Participants With Adverse Events, Serious Adverse Events, Infections and Injection Site Reactions | Up to 2 Years | AEs with onset or worsening on or after date of first dose of study treatment. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1 equal (=) Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE. SAE is any untoward medical occurrence that results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. |
| Tolerance Related Guselkumab Treatment | Up to 2 Years | Tolerance Related guselkumab treatment will be reported. |
| Dose at Initiation of Guselkumab | At Months 0, 3, 6, 12, 18 and 24 | Dose at initiation of guselkumab will be reported. |
| Treatment Interval at Initiation of Guselkumab | At Months 0, 3, 6, 12, 18 and 24 | Treatment interval at initiation of guselkumab will be reported. |
| Type of Injection | At Months 0, 3, 6, 12, 18 and 24 | Type of injection will be reported. |
| Change From Baseline in 12-item Psoriatic Arthritis Impact of Disease Questionnaire (PsAID-12) Questionnaire Score | Baseline, Months 0, 3, 6, 12, 18 and 24 | The PsAID-12 questionnaire was designed to assess the impact of disease, with questions on pain, physical function, fatigue, coping and depression. It is a validated, self-administered questionnaire developed for use in clinical practice that assesses the impact of PsA on patients' lives. It consists of 12 questions, each answered using a numerical rating scale. Questions related to pain, skin problems, work and/or leisure activities, discomfort, embarrassment and/or shame, social participation, and anger, fear, and uncertainty, and depression are scored from 0 (none) to 10 (extreme), functional capacity and sleep disturbance are scored from 0 (no difficulty) to 10 (extreme difficulty) and coping is scored from 0 (very well) to 10 (very poorly). |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Each Visit After Baseline | Baseline, Months 0, 3, 6, 12, 18 and 24 | The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) was developed to measure disease activity in patients with ankylosing spondylitis. It consists of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (also called enthesitis, or inflammation of tendons and ligaments), morning stiffness duration and morning stiffness severity. Each symptom is assessed on a scale of 0-10 where 0 indicates no pain or discomfort and 10 indicates maximum pain or discomfort. To give each symptom equal weighting, the mean (average) of the 2 scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score. Scores of 4 or greater suggest suboptimal control of disease. |
| Satisfaction of Treatment for the Participants | At Months 3, 6, 12, 18 and 24 | The satisfaction of treatment for the participant will be assessed using a 5-point Likert scale, ("Very dissatisfied Dissatisfied Neither satisfied nor dissatisfied Satisfied Very satisfied"). The scale includes two patient reported questions: "1) How satisfied or dissatisfied are you with the overall convenience of this medication" and "2) How satisfied or dissatisfied are you with the ability of this medication ability to treat your condition?" Scores range from Very dissatisfied to Very satisfied and will be used to evaluate satisfaction with guselkumab treatment. |
| Number of Participants Reporting Change of Injection Frequency | At Months 0, 3, 6, 12, 18 and 24 | Participants reporting change of injection frequency (Q4 to Q8 or Q8 to Q4) and its reason will be reported. |
| Satisfaction of Treatment Care Management and Patient Relationship for the Rheumatologist | At Months 3, 6, 12, 18 and 24 | Satisfaction of treatment care management and patient relationship for the rheumatologist will be assessed using a 5-point Likert scale specified as : "Very dissatisfied, Dissatisfied, Neither satisfied nor dissatisfied, Satisfied and Very satisfied." The physician-reported questions are: "1) How satisfied or dissatisfied are you with this drug overall for this patient?" and "2) How satisfied or dissatisfied are you with the ease of managing your patient with guselkumab?" |
| Number of Participant With Co-occurring Treatments Linked to PSA | At Months 0, 3, 6, 12, 18 and 24 | Participants with co-occurring treatments linked to PSA will be reported. |
| Number of Participants With Reason for Choosing Guselkumab From the Therapeutic Arsenal | At Months 0, 3, 6, 12, 18 and 24 | Participants with reason for choosing guselkumab from the therapeutic arsenal will be reported. |
Countries
France
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen-Cilag France Clinical Trial
Janssen-Cilag France
Outcome results
None listed