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Psoriatic Arthritis (PsA) is a comorbidity that affects a significant proportion of participants with moderate or severe psoriasis. The purpose of this study was to describe the profile of patients with moderate or severe plaque psoriasis (Ps) in Colombia and to evaluate adalimumab efficacy and safety profile.
Psoriasis is a chronic inflammatory disease affecting 1% to 3% of the population worldwide. A significant portion (5%-40%) of participants with psoriasis develop PsA, a chronic inflammatory arthritis that causes progressive joint damage, reduced functionality and increased mortality risk. Skin disease typically manifests before arthritis in more than 80% of PsA participants, and psoriasis symptoms usually precede joint symptoms by an average of 10 years. Participants with psoriasis who have comorbid PsA incur substantially increased cost of care and experience greater impairment of physical functioning and quality of life compared with participants with psoriasis alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate or severe plaque psoriasis | Participants with moderate or severe plaque psoriasis treated with adalimumab |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Developed Psoriatic Arthritis (PsA) | A participant is said to have PsA if they meet the following criteria:
| At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
| Percentage of Participants Who Developed Signs or Symptoms of PsA | Signs or symptoms were defined as mentioning at the rheumatologist visit any joint symptoms prior to or during the visit or a total number of inflamed joints greater than 0. | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time to First Occurrence of PsA Signs or Symptoms | The measure of time from Psoriasis diagnosis to the appearance of PsA signs or symptoms. | Baseline up to Visit 4 (month 12) |
| Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score |
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Inclusion Criteria:
Exclusion Criteria:
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Participants treated with adalimumab, per approved label, with moderate or severe plaque psoriasis
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| Name | Affiliation | Role |
|---|---|---|
| Manuel G Uribe | Abbvie SAS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 48347 | Barranquilla | Colombia | ||||
| Site Reference ID/Investigator# 48349 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate or Severe Psoriasis | Participants with moderate or severe psoriasis in treatment with adalimumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The PASI score was used to measure the severity of psoriasis. It combined the assessment of the severity of lesions and the area affected into a single score ranging from 0 (no disease) to 72 (maximal disease). |
| At Baseline, Visit 2 (month 2), Visit 3 (month 6) and Visit 4 (month 12) |
| Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA | Percentage of participants with comorbidities (metabolic syndrome, hypertension, diabetes, atherosclerosis, obesity, alcohol and other associated comorbidities) was assessed. | Baseline up to Visit 4 (month 12) |
| Mean Change in Quality of Life (QoL) | The Short Form-36 was a self-reported questionnaire used to measure the QoL of participants in eight main health dimensions (physical functioning; bodily pain; role limitations due to physical health, personal, and emotional problems; emotional well-being; social functioning; vitality; and general health perception). The score from each health dimension was added together for a QoL score on a scale of 0 - 100; a higher score indicated a better QoL. | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
| Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score | The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point). CASPER scores range from 1 to 6, with 6 indicating a more definitive diagnosis of PsA. | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
| Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist | The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point). | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
| Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero | Pressure and joint manipulation by physical examination on 68 or 66 joints or regions (34 or 32 per body side, hip joints excluded) were assessed for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC was 0 - 68 and 0 - 66, respectively; with higher scores indicating worse conditions. | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
| Percentage of Participants With Joint Symptoms | Joint symptoms were evaluated by presence or absence of peripheral arthritis, morning stiffness and participant reported joint symptoms. | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
| Incidence Rate of PsA Since Psoriasis Diagnosis | The number of new PsA cases were determined by:
| Baseline up to Visit 4 (month 12) |
| Change in the Subject Proportion That Achieved a PASI (Psoriasis Area and Severity Index) Reduction of ≥50% | This outcome measure was not calculated. | At Baseline, Week 24, and Week 48 |
| Barranquilla |
| Colombia |
| Site Reference ID/Investigator# 53045 | Barranquilla | Colombia |
| Site Reference ID/Investigator# 53047 | Bogotá | Colombia |
| Site Reference ID/Investigator# 78533 | Bogotá | Colombia |
| Site Reference ID/Investigator# 48345 | Cali | Colombia |
| Site Reference ID/Investigator# 48346 | Cali | Colombia |
| Site Reference ID/Investigator# 59342 | Cali | Colombia |
| Site Reference ID/Investigator# 48342 | Cartagena | Colombia |
| Site Reference ID/Investigator# 48348 | Cartagena | Colombia |
| Site Reference ID/Investigator# 53050 | Cartagena | Colombia |
| Site Reference ID/Investigator# 48351 | Medellín | Colombia |
| Site Reference ID/Investigator# 48353 | Medellín | Colombia |
| Site Reference ID/Investigator# 53046 | Medellín | Colombia |
| Site Reference ID/Investigator# 53049 | Medellín | Colombia |
| Completed Visit 1 to Dermatologist |
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| Completed Visit 1 to Rheumatologist |
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| Completed Visit 2 to Dermatologist |
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| Completed Visit 3 to Dermatologist |
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| Completed Visit 3 to Rheumatologist |
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| Completed Visit 4 to Dermatologist |
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| Completed Visit 4 to Rheumatologist |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate or Severe Psoriasis | Participants with moderate or severe psoriasis in treatment with adalimumab |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Participants who indicated more than one race are referred to as "Metis" | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| C-Reactive Protein (CRP) (N=10) | Data is based on available information. | Mean | Standard Deviation | mg/dl |
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| Study Specific Characteristic | Participants with family history of PsA is based on available information from participants who completed the visits to the rheumatologist. | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Mean Time to First Occurrence of PsA Signs or Symptoms | The measure of time from Psoriasis diagnosis to the appearance of PsA signs or symptoms. | Participants who completed at least one of the follow up visits to the rheumatologist. | Posted | Mean | 95% Confidence Interval | Years | Baseline up to Visit 4 (month 12) |
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| Secondary | Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score | The PASI score was used to measure the severity of psoriasis. It combined the assessment of the severity of lesions and the area affected into a single score ranging from 0 (no disease) to 72 (maximal disease). | ITT population | Posted | Mean | Standard Deviation | PASI score | At Baseline, Visit 2 (month 2), Visit 3 (month 6) and Visit 4 (month 12) |
|
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| Secondary | Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA | Percentage of participants with comorbidities (metabolic syndrome, hypertension, diabetes, atherosclerosis, obesity, alcohol and other associated comorbidities) was assessed. | Participants who completed at least one of the follow up visits to the rheumatologist. | Posted | Number | Percentage of participants | Baseline up to Visit 4 (month 12) |
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| Secondary | Mean Change in Quality of Life (QoL) | The Short Form-36 was a self-reported questionnaire used to measure the QoL of participants in eight main health dimensions (physical functioning; bodily pain; role limitations due to physical health, personal, and emotional problems; emotional well-being; social functioning; vitality; and general health perception). The score from each health dimension was added together for a QoL score on a scale of 0 - 100; a higher score indicated a better QoL. | ITT population | Posted | Mean | Standard Deviation | Score on scale | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score | The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point). CASPER scores range from 1 to 6, with 6 indicating a more definitive diagnosis of PsA. | Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available. | Posted | Mean | Standard Deviation | CASPAR score | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
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| Secondary | Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist | The CASPAR criteria permits the diagnosis of PsA in spite of low rheumatoid factor positivity. To be classified as having PsA, a participant must have inflammatory articular disease (joint, spine, entheseal) with greater than or equal to 3 of the following 5 points: evidence of psoriasis (current, history of, or family history of); psoriatic nail dystrophy; a negative RF test result; dactylitis (history of or current); and radiographic evidence of juxa-articular new bone formation. Only current psoriasis (2 points) was weighted more heavily than the other features (1 point). | Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available. | Posted | Number | Percentage of participants | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
|
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| Secondary | Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero | Pressure and joint manipulation by physical examination on 68 or 66 joints or regions (34 or 32 per body side, hip joints excluded) were assessed for TJC or SJC, respectively. Both joint tenderness and swelling were classified as present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The total TJC or SJC was derived as the sum of the tender and swollen joints; the range for TJC and SJC was 0 - 68 and 0 - 66, respectively; with higher scores indicating worse conditions. | Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available. | Posted | Number | Percentage of participants | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
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| Secondary | Percentage of Participants With Joint Symptoms | Joint symptoms were evaluated by presence or absence of peripheral arthritis, morning stiffness and participant reported joint symptoms. | Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available. | Posted | Number | Percentage of participants | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
|
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| Primary | Percentage of Participants Who Developed Psoriatic Arthritis (PsA) | A participant is said to have PsA if they meet the following criteria:
| Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available. | Posted | Number | Percentage of participants | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
|
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| Primary | Percentage of Participants Who Developed Signs or Symptoms of PsA | Signs or symptoms were defined as mentioning at the rheumatologist visit any joint symptoms prior to or during the visit or a total number of inflamed joints greater than 0. | Participants who completed the visits (visit 3 and visit 4) to the rheumatologist and for whom information was available. | Posted | Number | Percentage of participants | At Baseline, Visit 3 (month 6) and Visit 4 (month 12) |
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| Secondary | Incidence Rate of PsA Since Psoriasis Diagnosis | The number of new PsA cases were determined by:
| ITT population | Posted | Number | 95% Confidence Interval | new PsA cases per 100 person years | Baseline up to Visit 4 (month 12) |
|
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| Secondary | Change in the Subject Proportion That Achieved a PASI (Psoriasis Area and Severity Index) Reduction of ≥50% | This outcome measure was not calculated. | Not Posted | At Baseline, Week 24, and Week 48 |
Adverse events were collected from signing of informed consent until 70 days or 5 half-lives of drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate or Severe Psoriasis | Participants with moderate or severe psoriasis in treatment with Adalimumab | 16 | 52 | 5 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA V17.0 | Non-systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Localised oedema | General disorders | MedDRA V17.0 | Non-systematic Assessment |
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| No therapeutic response | General disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Tonsillitis bacterial | Infections and infestations | MedDRA V17.0 | Non-systematic Assessment |
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| Alpha 1 fetoprotein increased | Investigations | MedDRA V17.0 | Non-systematic Assessment |
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| Cardiac murmur | Investigations | MedDRA V17.0 | Non-systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA V17.0 | Non-systematic Assessment |
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| Transaminases increased | Investigations | MedDRA V17.0 | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Dactylitis | Musculoskeletal and connective tissue disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V17.0 | Non-systematic Assessment |
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| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V17.0 | Non-systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V17.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Bipolar I disorder | Psychiatric disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Breast calcifications | Reproductive system and breast disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Mammary duct ectasia | Reproductive system and breast disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Rash generalized | Skin and subcutaneous tissue disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Mastectomy | Surgical and medical procedures | MedDRA V17.0 | Non-systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA V17.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like illness | General disorders | MedDRA V17.0 | Non-systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Presence of Metabolic Syndrome |
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| Presence of Hypertension |
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| Presence of Family History of PsA (N=49) |
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| Prior Methotrexate Use |
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| Current Methotrexate Use |
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| Prior Biologic Therapy |
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