Trial · NCT02376790
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 37
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 | Baseline and week 24 | A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: * ≥ 20% improvement in 68 tender joint count; * ≥ 20% improvement in 66 swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein concentration. |
| Secondary | Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24 | Week 24 | Minimal Disease Activity (MDA) is a measure of low disease activity specific for psoriatic arthritis (PsA) that incorporates measures of joint and entheseal inflammation, skin disease, patient reported outcomes and functional disability to assess disease activity. Participants were classified as achieving MDA if they fulfilled 5 of the following 7 outcome measures: * Tender joint count (0-68) ≤ 1 * Swollen joint count (0-66) ≤ 1 * Body surface area (BSA) involvement with psoriasis (0% to 100%) ≤ 3% * Patient global assessment of joint pain VAS (0-100) ≤ 15 * Patient global assessment of disease activity VAS (0-100) ≤ 20 * HAQ-DI (0-3) ≤ 0.5 * Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index (18 sites assessed for enthesitis with an overall score of 0 - 16) ≤ 1 |
| Secondary | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: * ≥ 20% improvement in 68 tender joint count; * ≥ 20% improvement in 66 swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein. |
| Secondary | Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met: * ≥ 50% improvement in 68 tender joint count; * ≥ 50% improvement in 66 swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein. |
| Secondary | Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met: * ≥ 70% improvement in 68 tender joint count; * ≥ 70% improvement in 66 swollen joint count; and * ≥ 70% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein. |
| Secondary | Change From Baseline in Tender Joint Count Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | The tender joint count is an assessment of the pain and/or tenderness of 68 joints using a 0 to 1 point scale (0 = none, 1 = present). The total tender joint count is calculated by summing the number of joints with present tenderness. |
| Secondary | Change From Baseline in Swollen Joint Count Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | The swollen joint count is an assessment of the swelling of 66 joints using a 0 to 1 point scale (0 = none, 1 = present). The total swollen joint count is calculated by summing the number of joints with present swelling. |
| Secondary | Change From Baseline in Physician Global Assessment of Disease Activity Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | A global assessment of the participant's arthritis assessed by the physician on a 100 mm visual analog scale (VAS) where 0 mm = No activity at all and 100 mm = Worst activity imaginable. |
| Secondary | Change From Baseline in Patient Global Assessment of Disease Activity Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | A global assessment of the participant's arthritis, assessed by the participant on a 100 mm VAS where 0 mm = No arthritis activity at all and 100 mm = Worst arthritis activity imaginable. |
| Secondary | Change From Baseline in Patient Global Assessment of Joint Pain Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | A global assessment of the severity of the participant's joint pain, assessed by the participant on a 100 mm VAS where 0 mm = No pain at all and 100 mm = Worst pain imaginable. |
| Secondary | Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability. |
| Secondary | Change From Baseline in C-reactive Protein Concentration Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | C-reactive protein (CRP) is a specific measure of inflammatory activity. |
| Secondary | Percentage of Participants With a American Minimal Disease Activity (MDA) Response Over Time | Weeks 4, 8, 12, 24, 36, and 48 | Minimal Disease Activity (MDA) is a measure of low disease activity specific for psoriatic arthritis (PsA) that incorporates measures of joint and entheseal inflammation, skin disease, patient reported outcomes and functional disability to assess disease activity. Participants were classified as achieving MDA if they fulfilled 5 of the following 7 outcome measures: * Tender joint count (0-68) ≤ 1 * Swollen joint count (0-66) ≤ 1 * Body surface area (BSA) involvement with psoriasis (0% to 100%) ≤ 3% * Patient global assessment of joint pain VAS (0-100) ≤ 15 * Patient global assessment of disease activity VAS (0-100) ≤ 20 * HAQ-DI (0-3) ≤ 0.5 * Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index (18 sites assessed for enthesitis with an overall score of 0 - 16) ≤ 1 |
| Secondary | Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Over Time | Baseline and weeks 12, 24, 36, and 48 | PASDAS is a measure of disease activity derived from the following variables: * Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) * 68 tender joint count * 66 swollen joint count * Short Form-36 Questionnaire (SF-36) physical component summary (general health status on a scale from 0-100) * Tender dactylitis count (each digit assessed for tender dactylitis; total score 0-20) * Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6) * CRP level (mg/L) The composite score is a weighted index where higher scores indicate more severe disease. |
| Secondary | Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the following items: * 28 tender joint count, * 28 swollen joint count, * Patient's Global Assessment of Disease Activity measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest; * Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. |
| Secondary | Change From Baseline in Simplified Disease Activity Index (SDAI) Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | The Simplified Disease Activity Index (SDAI) is a composite index that is calculated as the sum of the following items: * 28 tender joint count, * 28 swollen joint count, * Patient's Global Assessment of Disease Activity measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest; * Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. * CRP The SDAI score ranges from 0 to 86 with higher scores representing worse disease. |
| Secondary | Change From Baseline in the Disease Activity Score 28 (DAS28) Over Time | Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 | The DAS28 measures the severity of disease at a specific time and is derived from the following variables: * 28 tender joint count * 28 swollen joint count * C-reactive protein (CRP) * Patient's global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. |
| Secondary | Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24 | Baseline and week 24 | The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring in 8 functional areas: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability. |
| Secondary | Change From Baseline in Medical Outcomes Health Survey Short Form 36 Items Version 2 (SF-36 v2) at Week 24 | Baseline and week 24 | The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains. Two summary component scores are calculated: mental component summary score (MCS) and physical component summary score (PCS). The MCS consists of social functioning, vitality, mental health, and role-emotional scales and the PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. |
| Secondary | Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Week 24 | Baseline and week 24 | The modified NAPSI scale is a grading system for nail psoriasis that incorporates the following 7 clinical features: * pitting (scores 0-3, depending on the number of pits) * nail plate crumbling (scores 0-3, depending on the % of nail involvement) * onycholysis and oil drop dyschromia (scores 0-3, depending on the % of nail involvement) * leukonychia (0 = absent, 1 = present) * red spots in lunula (0 = absent, 1 = present) * nail bed hyperkeratosis (0 = absent, 1 = present) * splinter hemorrhages (0 = absent, 1 = present) In participants with fingernails involved with psoriasis, each fingernail was scored at baseline to determine the worst fingernail (ie, the fingernail with the highest mNAPSI score). This fingernail was followed for the remainder of the study. mNAPSI scores range from 0-13 where higher scores represent worse nail disease. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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