An observational study in Psoriatic Arthritis, sponsored by Janssen Cilag S.A.S.. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Janssen Cilag S.A.S. (part of Johnson & Johnson) · Observational
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Among 37 studies in Arthritis, Psoriatic by Johnson & Johnson — 5 open to participants now, 13 under way, 5 of them phase 3. Arthritis, Psoriatic · Johnson & Johnson.
Among the 37 studies in Arthritis, Psoriatic by Johnson & Johnson, this one is the 9th largest by enrollment of the 12 observational ones that give a count, is one of 3 that started in 2017, is one of 12 observational ones, and was the 20th registered.
600 studies on the registry are indexed under Arthritis, Psoriatic; 128 are open to participants now.
Browse Arthritis, Psoriatic studies →5 of the 37 studies in Arthritis, Psoriatic by Johnson & Johnson are open now, in 12 countries. Recruiting first, the newest first:
Janssen Research & Development, LLC · Sites in United States
Ages 18+ · Women only
Janssen-Cilag Ltd. · Sites in France
Ages 18+
Janssen Research & Development, LLC · Sites in Italy
Ages 18+
Johnson & Johnson Private Limited · Sites in India
Ages 18+
Janssen Research & Development, LLC · Sites in United States, Argentina, Australia and 15 more countries
Ages 3+
By country, each count listing its studies:
Of the 88 Arthritis, Psoriatic studies recruiting now, 53 (60%) set no upper age limit and 26 (30%) stop at 75 or younger; 12 take children under 18; 12 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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37 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 221 is below the median of 300 across 243 observational studies indexed under Arthritis, Psoriatic.
Median enrollment 196 across the 25 interventional studies, 681 across the 12 observational. Of the 23 that completed or were terminated, 13 (57%) have results posted.
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This study is registered under Janssen Cilag S.A.S., one of the names counted as Johnson & Johnson. Under that name alone:
Janssen Cilag S.A.S. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
8 of the studies in Arthritis, Psoriatic by Johnson & Johnson that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06807424Phase 3Janssen Research & Development, LLCA Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis | 2027-02-10 |
| NCT05092269Phase 3Janssen Research & Development, LLCA Long-term Extension Study of Ustekinumab in Pediatric Participants | 2027-09-29 |
| NCT04929210Janssen Research & Development, LLCA Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease | 2027-04-01 |
| NCT07141004Johnson & Johnson Private LimitedA Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA) | 2027-06-05 |
| NCT07321873Janssen Research & Development, LLCA Study to Evaluate the Efficacy and Safety of JNJ-88545223 for the Treatment of Participants With Active Psoriatic Arthritis | 2027-06-28 |
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Among the 37 studies in Arthritis, Psoriatic by Johnson & Johnson, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The primary purpose of this study is to describe the Psoriatic Arthritis (PsA) participant profiles depending on whether their disease is managed by a dermatologist or by a rheumatologist in routine practice.
Participants with a confirmed diagnosis of Psoriatic Arthritis (PsA) according to the clinical practice and for which a treatment with ustekinumab is indicated as a first (biological-naïve participants) or a second line (biological-experienced participants) of biological disease-modifying antirheumatic drugs (bDMARD) for PsA / psoriasis (PsO) will be observed depending on whether their disease is managed by a dermatologist or by a rheumatologist in routine practice.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who will receive ustekinumab (as a first or second line of biologic disease modifying anti-rheumatic drug \[bDMARD\] therapy) along with other co-medications as per clinical dematologist's discretion will be observed in this study. Ustekinumab will not be provided by the sponsor. The treatment by ustekinumab must have been decided by the physician prior to the decision to include the participant in the study. Only data available from a participant's source medical records will be collected. Additionally investigators will be asked to obtain (or record where available) Patient-Reported Outcome (PRO) data from participants participating in this study.
Drug: Ustekinumab
Participants who will receive ustekinumab (as a first or second line of bDMARD therapy) along with other co-medications as per clinical rheumatologist's discretion will be observed in this study. Ustekinumab will not be provided by the sponsor. The treatment by ustekinumab must have been decided by the physician prior to the decision to include the participant in the study. Only data available from a participant's source medical records will be collected. Additionally investigators will be asked to obtain (or record where available) PRO data from participants participating in this study.
Drug: Ustekinumab
All participants will receive ustekinumab at study entry. Ustekinumab will not be provided by the sponsor. The treatment decision must have been taken by the investigator prior to, and independently of the participant's inclusion into the study following the standard clinical practice. Only data available from a participant's source medical records will be collected.
Number of Participants With Swelling of Joints at Baseline
Participants with swollen 28-joints or 66/68-joints counts according to the practices will be evaluated.
Time frame: Baseline (Week 0)
Number of Participants With Swelling of Joints at Week 16
Participants with swollen 28-joints or 66/68-joints counts according to the practice will be evaluated.
Time frame: Week 16
Number of Participants With Swelling of Joints at Week 28
Participants with swollen 28-joints or 66/68-joints counts according to the practice will be evaluated.
Time frame: Week 28
Number of Participants With Tenderness of Joints at Baseline
Participants with tender 28-joints or 66/68-joints counts according to the practice will be evaluated.
Time frame: Baseline (Week 0)
Number of Participants With Tenderness of Joints at Week 16
Participants with tender 28-joints or 66/68-joints counts according to the practice will be evaluated.
Time frame: Week 16
Number of Participants With Tenderness of Joints at Week 28
Participants with tender 28-joints or 66/68-joints counts according to the practice will be evaluated.
Time frame: Week 28
Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Week 16
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0 = no disease activity to 100 = maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from baseline indicated improvement.
Time frame: Baseline and Week 16
Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Week 28
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], participant's global assessment of disease activity \[visual analog scale: 0 = no disease activity to 100 = maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from baseline indicated improvement.
Time frame: Baseline and Week 28
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good Response at Baseline
Clinical response will be assessed according to EULAR categorical DAS28 response criteria. DAS28 score: participant's disease activity calculated using TJC28, SJC28, PGH \[VAS: 0=no disease activity to 100=maximum disease activity\] and ESR. Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28 less than or equal to (\<=) 3.2 or a change from baseline less than (\<) -1.2.
Time frame: Baseline (Week 0)
Percentage of Participants Achieving EULAR Good Response at Week 16
Clinical response will be assessed according to EULAR categorical DAS28 response criteria. DAS28 score: participant's disease activity calculated using TJC28, SJC28, PGH \[VAS: 0=no disease activity to 100=maximum disease activity\] and ESR. Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28 \<= 3.2 or a change from baseline \< -1.2.
Time frame: Week 16
Percentage of Participants Achieving EULAR Good Response at Week 28
Clinical response will be assessed according to EULAR categorical DAS28 response criteria. DAS28 score: participant's disease activity calculated using TJC28, SJC28, PGH \[VAS: 0=no disease activity to 100=maximum disease activity\] and ESR. Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28 \<= 3.2 or a change from baseline \< -1.2.
Time frame: Week 28
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Baseline
The MDA is a state of disease activity deemed a useful target of treatment by both the participant and physician. The percentage of participants achieving MDA will be determined based on participants fulfilling 5 of the following 7 criteria must be met: Tender joint count \<= 1; Swollen joint count \<= 1; psoriasis area and severity index (PASI) \<= 1 or BSA \<= 3; Participant pain VAS \<= 15; Participant global activity VAS \<= 20; Health Assessment Questionnaire (HAQ) \<= 0.5; Tender enthesial points \<= 1.
Time frame: Baseline (Week 0)
Percentage of Participants Achieving MDA at Week 16
The MDA is a state of disease activity deemed a useful target of treatment by both the participant and physician. The percentage of participants achieving MDA will be determined based on participants fulfilling 5 of the following 7 criteria must be met: Tender joint count \<= 1; Swollen joint count \<= 1; PASI \<= 1 or BSA \<= 3; Participant pain VAS \<= 15; Participant global activity VAS \<= 20; HAQ \<= 0.5; Tender enthesial points \<= 1.
Time frame: Week 16
Percentage of Participants Achieving MDA at Week 28
The MDA is a state of disease activity deemed a useful target of treatment by both the participant and physician. The percentage of participants achieving MDA will be determined based on participants fulfilling 5 of the following 7 criteria must be met: Tender joint count \<= 1; Swollen joint count \<= 1; PASI \<= 1 or BSA \<= 3; Participant pain VAS \<= 15; Participant global activity VAS \<= 20; HAQ \<= 0.5; Tender enthesial points \<= 1.
Time frame: Week 28
Change from Baseline in Physician's Global Assessment of Disease Activity - Psoriatic Arthritis (PGA-PsA) Visual Analogue Scale (VAS) Scores at Week 16
Physician's Global Assessment of Disease Activity (PGA-PsA) will be measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).
Time frame: Baseline and Week 16
Change from Baseline in PGA-PsA VAS Scores at Week 28
Physician's Global Assessment of Disease Activity (PGA) will be measured using a visual analogue scale with scores ranging from 0 to 100 (higher scores indicate worse disease activity).
Time frame: Baseline and Week 28
Change from Baseline in Patient's Global Assessment (PtGA-PsA) VAS Scores at Week 16
The PtGA by VAS measuring the overall way the disease affects the participants at a point in time. The score will be recorded as a single vertical mark on a 100 millimeter (mm) visual analogic scale (VAS), with 0 representing the lowest level of disease activity and 100 representing the highest.
Time frame: Baseline and Week 16
Change from Baseline in PtGA-PsA VAS Scores at Week 28
The PtGA by VAS measuring the overall way the disease affects the participants at a point in time. The score will be recorded as a single vertical mark on a 100 millimeter (mm) visual analogic scale (VAS), with 0 representing the lowest level of disease activity and 100 representing the highest.
Time frame: Baseline and Week 28
Participant's Pain VAS Scores at Baseline
The score will be recorded as a single vertical mark placed by participant on a 100 mm visual analogic scale (VAS), with 0 representing the no pain of and 100 representing the highest pain as severe as can be imagined. The distance from the mark will be recorded.
Time frame: Baseline (Week 0)
Participant's Pain VAS Scores at Week 16
The score will be recorded as a single vertical mark placed by participant on a 100 mm visual analogic scale (VAS), with 0 representing the no pain of and 100 representing the highest pain as severe as can be imagined. The distance from the mark will be recorded.
Time frame: Week 16
Participant's Pain VAS Scores at Week 28
The score will be recorded as a single vertical mark placed by participant on a 100 mm visual analogic scale (VAS), with 0 representing the no pain and 100 representing the highest pain as severe as can be imagined. The distance from the mark will be recorded.
Time frame: Week 28
Percentage of Participants With Dactylitis at Baseline
Percentage of participants with dactylitis will be evaluated.
Time frame: Baseline (Week 0)
Percentage of Participants With Dactylitis at Week 16
Percentage of participants with dactylitis will be evaluated.
Time frame: Week 16
Percentage of Participants With Dactylitis at Week 28
Percentage of participants with dactylitis will be evaluated.
Time frame: Week 28
Change from Baseline in Dactylitis Count at Week 16
The change from baseline in total number of digits of the hands and feet (that is, 0 to 20) with dactylitis will be evaluated.
Time frame: Baseline and Week 16
Change from Baseline in Dactylitis Count at Week 28
The change from baseline in total number of digits of the hands and feet (that is, 0 to 20) with dactylitis will be evaluated.
Time frame: Baseline and Week 28
Percentage of Participants With Dactylitis Complete Resolution at Baseline
Percentage of participants with complete resolution of dactylitis in hands and feet will be evaluated.
Time frame: Baseline (Week 0)
Percentage of Participants With Dactylitis Complete Resolution at Week 16
Percentage of participants with complete resolution of dactylitis in hands and feet will be evaluated.
Time frame: Week 16
Percentage of Participants With Dactylitis Complete Resolution at Week 28
Percentage of participants with complete resolution of dactylitis in hands and feet will be evaluated.
Time frame: Week 28
Percentage of Participants With Enthesitis at Baseline
Percentage of participants with enthesitis will be evaluated.
Time frame: Baseline (Week 0)
Percentage of Participants With Enthesitis at Week 16
Percentage of participants with enthesitis will be evaluated.
Time frame: Week 16
Percentage of Participants With Enthesitis at Week 28
Percentage of participants with enthesitis will be evaluated.
Time frame: Week 28
Change from Baseline in Enthesitis Score at Week 16
Enthesitis will be documented using the Leeds Enthesitis Index (LEI). The LEI evaluates the presence or absence of pain by applying local pressure to lateral epicondyle (left and right), medial femoral condyle (left and right), and Achilles tendon insertion (left and right). LEI Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Time frame: Baseline and Week 16
Change from Baseline in Enthesitis Score at Week 28
Enthesitis will be documented using the Leeds Enthesitis Index (LEI). The LEI evaluates the presence or absence of pain by applying local pressure to lateral epicondyle (left and right), medial femoral condyle (left and right), and Achilles tendon insertion (left and right). LEI Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Time frame: Baseline and Week 28
Percentage of Participants With Enthesitis Complete Resolution at Week 16
Percentage of participants with complete resolution from enthesitis will be evaluated.
Time frame: Week 16
Percentage of Participants With Enthesitis Complete Resolution at Week 28
Percentage of participants with complete resolution from enthesitis will be evaluated.
Time frame: Week 28
Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 16
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hr). A higher rate is consistent with inflammation.
Time frame: Baseline and Week 16
Change From Baseline in ESR at Week 28
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hr). A higher rate is consistent with inflammation.
Time frame: Baseline and Week 28
Change From Baseline in C-Reactive Protein (CRP) at Week 16
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline and Week 16
Change From Baseline in CRP at Week 28
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline and Week 28
Percentage of Participants With Psoriatic Arthritis (PsA) Extra-articular Manifestations at Baseline
Percentage of participants with PsA extraarticular manifestations will be assessed. Extra-articular manifestations are symptoms and diseases that occur in parts of the body other than joints. These included the presence of enthesitis (inflammation of ligaments and/or tendons at the site of insertion into bones), uveitis (inflammation of the middle layer of the eye), psoriasis (a skin condition that causes itchy or sore patches of thick, red skin with silvery scales), and Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
Time frame: Baseline (Week 0)
Percentage of Participants With PsA Extra-articular Manifestations at Week 16
Percentage of participants with PsA extraarticular manifestations will be assessed. Extra-articular manifestations are symptoms and diseases that occur in parts of the body other than joints. These included the presence of enthesitis (inflammation of ligaments and/or tendons at the site of insertion into bones), uveitis (inflammation of the middle layer of the eye), psoriasis (a skin condition that causes itchy or sore patches of thick, red skin with silvery scales), and Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
Time frame: Week 16
Percentage of Participants With PsA Extra-articular Manifestations at Week 28
Percentage of participants with PsA extraarticular manifestations will be assessed. Extra-articular manifestations are symptoms and diseases that occur in parts of the body other than joints. These included the presence of enthesitis (inflammation of ligaments and/or tendons at the site of insertion into bones), uveitis (inflammation of the middle layer of the eye), psoriasis (a skin condition that causes itchy or sore patches of thick, red skin with silvery scales), and Inflammatory bowel disease (Crohn's disease or ulcerative colitis).
Time frame: Week 28
Percentage of Participants With Body Surface Area (BSA) Psoriasis (PsO) Skin Involvement at Baseline
Psoriasis skin involvement will be documented using categories: \<3 percent (%), 3% to 10%, and \>10% of BSA. The typical method to assess BSA is to consider the surface area of the participant's handprint (palm and fingers) as representing 1% of the body's surface area.
Time frame: Baseline (Week 0)
Percentage of Participants With BSA PsO Skin Involvement at Week 16
Psoriasis skin involvement will be documented using categories: \<3 percent (%), 3% to 10%, and \>10% of BSA. The typical method to assess BSA is to consider the surface area of the participant's handprint (palm and fingers) as representing 1% of the body's surface area.
Time frame: Week 16
Percentage of Participants With BSA PsO Skin Involvement at Week 28
Psoriasis skin involvement will be documented using categories: \<3 percent (%), 3% to 10%, and \>10% of BSA. The typical method to assess BSA is to consider the surface area of the participant's handprint (palm and fingers) as representing 1% of the body's surface area.
Time frame: Week 28
Change From Baseline in Nail Involvement Scores at Week 16
Nail involvement will be evaluated by recording the total number of nails of the hands and feet (that is, 0 to 20) with PsA involvement.
Time frame: Baseline and Week 16
Change From Baseline in Nail Involvement Scores at Week 28
Nail involvement will be evaluated by recording the total number of nails of the hands and feet (that is, 0 to 20) with PsA involvement.
Time frame: Baseline and Week 28
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16
The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A participant must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.
Time frame: Baseline and Week 16
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 28
The Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis, consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. There are 4 possible responses for each question: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The score for each of the domains is the highest (worst) score in each domain. A participant must have a domain score for at least 6 of 8 domains to calculate a valid HAQ-DI score which is the sum of domain scores, divided by the number of domains that have a score for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.
Time frame: Baseline and Week 28
Percentage of Participants Achieving HAQ-DI Response at Baseline
Percentage of participants achieving HAQ-DI response that is change of greater than (\>) 0.3 will be evaluated.
Time frame: Baseline (Week 0)
Percentage of Participants Achieving HAQ-DI Response
Percentage of participants achieving HAQ-DI response that is change of \> 0.3 will be evaluated.
Time frame: Week 16
Percentage of Participants Achieving HAQ-DI Response at Week 28
Percentage of participants achieving HAQ-DI response that is change of \> 0.3 will be evaluated.
Time frame: Week 28
Change From Baseline in Psoriatic Arthritis Impact of Disease-12 (PsAID-12) Questionnaire Scores at Week 16
The PsAID-12 is a validated, self-administered questionnaire developed by EULAR for use in clinical practice that assesses the impact of PsA on participants' 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) and 10 (extreme difficulty) and coping is scored from 0 (very well) 10 (very poorly).
Time frame: Baseline and Week 16
Change From Baseline in PsAID-12 Questionnaire Scores at Week 28
The PsAID-12 is a validated, self-administered questionnaire developed by EULAR for use in clinical practice that assesses the impact of PsA on participants' 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) and 10 (extreme difficulty) and coping is scored from 0 (very well) 10 (very poorly).
Time frame: Baseline and Week 28
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 16
The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom.
Time frame: Baseline and Week 16
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Week 28
The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10cm visual analog scale (VAS), with 0 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom.
Time frame: Baseline and Week 28
Treatment Retention
Time from first ustekinumab administration to drug stop or switch or study withdrawal will be evaluated.
Time frame: Time from first ustekinumab administration to drug stop or switch or study withdrawal (approximately up to 28 weeks)
Ran from Apr 2017 to primary completion in Apr 2020, 35 months.
Of 52 industry-sponsored observational studies under Arthritis, Psoriatic, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 63. This study's 35 months is below that.
Counting every sponsor, half of 128 studies reached it within 47 months; a quarter within 28 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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