An observational study in Psoriasis and Psoriatic Arthritis, sponsored by AbbVie (prior sponsor, Abbott). Completed at 15 sites in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-12.
Sponsored by AbbVie (prior sponsor, Abbott) · Observational
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.
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 52 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants treated with adalimumab, per approved label, with moderate or severe plaque psoriasis
Exclusion Criteria:
Participants with moderate or severe plaque psoriasis treated with adalimumab
Percentage of Participants Who Developed Psoriatic Arthritis (PsA)
A participant is said to have PsA if they meet the following criteria: 1. PsA defined by a rheumatologist; or 2. A participant with inflamed joints \>0 and CASPAR score \>=3; or 3. Participant meeting at least one of the two previous definitions.
Time frame: 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.
Time frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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.
Time frame: Baseline up to Visit 4 (month 12)
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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: 1. PsA defined by a rheumatologist; or 2. A participant with inflamed joints \>0 and CASPAR score \>=3; or 3. Participant meeting at least one of the two previous definitions occurring over person time (defined as the overall sum of Psoriasis disease duration without PsA).
Time frame: 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.
Time frame: At Baseline, Week 24, and Week 48
| Milestone | Moderate or Severe Psoriasis |
|---|---|
| Started | 52 |
| Completed visit 1 to dermatologist | 52 |
| Completed visit 1 to rheumatologist | 49 |
| Completed visit 2 to dermatologist | 51 |
| Completed visit 3 to dermatologist | 48 |
| Completed visit 3 to rheumatologist | 39 |
| Completed visit 4 to dermatologist | 42 |
| Completed visit 4 to rheumatologist | 28 |
| Completed | 42 |
| Not completed | 10 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Adverse event | 3 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Adverse event with treatment failure | 1 |
| Withdrew: Other | 1 |
The measure of time from Psoriasis diagnosis to the appearance of PsA signs or symptoms.
| Years | Moderate or Severe Psoriasis |
|---|---|
| Mean Time to First Occurrence of PsA Signs or Symptoms | 23.17 (16.33 to 30.01) |
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).
| PASI score | Moderate or Severe Psoriasis |
|---|---|
| Baseline | 17.42 ± 12.11 |
| Change from Baseline at Visit 2 (N=51) | -11.56 ± 11.96 |
| Change from Baseline at Visit 3 (N=47) | -13.12 ± 12.69 |
| Change from Baseline at Visit 4 (N=41) | -15.17 ± 12.69 |
Percentage of participants with comorbidities (metabolic syndrome, hypertension, diabetes, atherosclerosis, obesity, alcohol and other associated comorbidities) was assessed.
| Percentage of participants | Moderate or Severe Psoriasis |
|---|---|
| Non-PsA participants (N=25) | 60.0 |
| PsA participants (N=19) | 52.6 |
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.
| Score on scale | Moderate or Severe Psoriasis |
|---|---|
| Physical Functioning (PF) at Baseline | 78.46 ± 28.66 |
| Change from Baseline in PF at Visit 3 (N=47) | -1.52 ± 25.80 |
| Change from Baseline in PF at Visit 4 (N=47) | -0.95 ± 24.92 |
| Role-Physical (RP) at Baseline | 68.75 ± 26.89 |
| Change from Baseline in RP at Visit 3 (N=47) | 6.52 ± 26.67 |
| Change from Baseline in RP at Visit 4 (N=42) | 6.55 ± 35.16 |
| Bodily Pain (BP) at Baseline (N=51) | 66.78 ± 29.73 |
| Change from Baseline in BP at Visit 3 (N=47) | -0.87 ± 32.08 |
| Change from Baseline in BP at Visit 4 (N=42) | 9.10 ± 34.82 |
| General Health (GH) at Baseline | 57.88 ± 23.55 |
| Change from Baseline in GH at Visit 3 (N=46) | 8.24 ± 28.30 |
| Change from Baseline in GH at Visit 4 (N=42) | 12.95 ± 31.45 |
| Vitality at Baseline | 60.58 ± 24.37 |
| Change from Baseline in vitality at Visit 3 (N=47) | 2.13 ± 24.18 |
| Change from Baseline vitality at Visit 4 (N=42) | 5.51 ± 30.78 |
| Social Functioning (SF) at Baseline | 66.35 ± 31.07 |
| Change from Baseline in SF at Visit 3 (N=47) | 13.56 ± 29.24 |
| Change from Baseline in SF at Visit 4 (N=42) | 13.39 ± 36.98 |
| Role-Emotional (RE) at Baseline | 68.11 ± 28.47 |
| Change from Baseline in RE at Visit 3 (N=47) | 6.03 ± 29.47 |
| Change from Baseline in RE at Visit 4 (N=42) | 15.67 ± 34.05 |
| Mental Health (MH) at Baseline | 64.13 ± 25.70 |
| Change from Baseline in MH at Visit 3 (N=47) | 6.28 ± 24.33 |
| Change from Baseline in MH at Visit 4 (N=42) | 5.45 ± 30.73 |
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.
| CASPAR score | Moderate or Severe Psoriasis |
|---|---|
| Baseline | 2.82 ± 0.73 |
| Change from Baseline at Visit 3 (N=38) | 0.05 ± 0.73 |
| Change from Baseline at Visit 4 (N=27) | -0.07 ± 0.83 |
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).
| Percentage of participants | Moderate or Severe Psoriasis |
|---|---|
| Baseline | 67.30 |
| Visit 3 (N=39) | 64.10 |
| Visit 4 (N=28) | 71.40 |
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.
| Percentage of participants | Moderate or Severe Psoriasis |
|---|---|
| SJC at Baseline | 24.50 |
| SJC at Visit 3 (N=39) | 12.80 |
| SJC at Visit 4 (N=28) | 7.10 |
| TJC at Baseline | 36.70 |
| TJC at Visit 3 (N=39) | 20.50 |
| TJC at Visit 4 (N=28) | 14.30 |
Joint symptoms were evaluated by presence or absence of peripheral arthritis, morning stiffness and participant reported joint symptoms.
| Percentage of participants | Moderate or Severe Psoriasis |
|---|---|
| Baseline | 61.20 |
| Visit 3 (N=39) | 30.80 |
| Visit 4 (N=28) | 25.00 |
A participant is said to have PsA if they meet the following criteria: 1. PsA defined by a rheumatologist; or 2. A participant with inflamed joints \>0 and CASPAR score \>=3; or 3. Participant meeting at least one of the two previous definitions.
| Percentage of participants | Moderate or Severe Psoriasis |
|---|---|
| Definition 1 - Visit 3 (N=38) | 47.4 |
| Definition 1 - Visit 4 (N=28) | 35.7 |
| Definition 2 - Baseline | 17.3 |
| Definition 2 - Visit 3 (N=39) | 10.3 |
| Definition 2 - Visit 4 (N=28) | 3.6 |
| Definition 3 - Visit 3 (N=39) | 46.2 |
| Definition 3 - Visit 4 (N=28) | 35.7 |
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.
| Percentage of participants | Moderate or Severe Psoriasis |
|---|---|
| Baseline | 61.2 |
| Visit 3 (N=39) | 33.3 |
| Visit 4 (N=28) | 25.0 |
The number of new PsA cases were determined by: 1. PsA defined by a rheumatologist; or 2. A participant with inflamed joints \>0 and CASPAR score \>=3; or 3. Participant meeting at least one of the two previous definitions occurring over person time (defined as the overall sum of Psoriasis disease duration without PsA).
| new PsA cases per 100 person years | Moderate or Severe Psoriasis |
|---|---|
| Incidence Rate of PsA Since Psoriasis Diagnosis | 2.66 (1.70 to 4.14) |
This outcome measure was not calculated.
Results for this outcome have not been posted.
Collected over Adverse events were collected from signing of informed consent until 70 days or 5 half-lives of drug. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moderate or Severe Psoriasis | — | 16/52 (30.8%) | 5/52 (9.6%) |
| Event | Moderate or Severe Psoriasis |
|---|---|
| Neck painMusculoskeletal and connective tissue disorders | 2/52 |
| Psoriatic arthropathyMusculoskeletal and connective tissue disorders | 2/52 |
| BlisterSkin and subcutaneous tissue disorders | 2/52 |
| PsoriasisSkin and subcutaneous tissue disorders | 2/52 |
| Rash generalizedSkin and subcutaneous tissue disorders | 2/52 |
| AnemiaBlood and lymphatic system disorders | 1/52 |
| Myocardial infarctionCardiac disorders | 1/52 |
| VertigoEar and labyrinth disorders | 1/52 |
| Abdominal painGastrointestinal disorders | 1/52 |
| AscitesGastrointestinal disorders | 1/52 |
| Event | Moderate or Severe Psoriasis |
|---|---|
| Influenza like illnessGeneral disorders | 5/52 |
| Age, Continuous(Years) | Moderate or Severe Psoriasis |
|---|---|
| Mean | 48.85 ± 14.66 |
| Sex: Female, Male(Participants) | Moderate or Severe Psoriasis |
|---|---|
| Female | 21 |
| Male | 31 |
| Race (NIH/OMB)(Participants) | Moderate or Severe Psoriasis |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 18 |
| More than one race | 34 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Moderate or Severe Psoriasis |
|---|---|
| Colombia | 52 |
| Weight(kg) | Moderate or Severe Psoriasis |
|---|---|
| Mean | 78.70 ± 14.70 |
| Body Mass Index (BMI)(kg/m^2) | Moderate or Severe Psoriasis |
|---|---|
| Mean | 28.83 ± 5.06 |
| C-Reactive Protein (CRP) (N=10)(mg/dl) | Moderate or Severe Psoriasis |
|---|---|
| Mean | 1.39 ± 1.63 |
| Study Specific Characteristic(Participants) | Moderate or Severe Psoriasis |
|---|---|
| Participants Who Smoke | 21 |
| Positive History of Comorbidities | 28 |
| Presence of Metabolic Syndrome | 8 |
| Presence of Hypertension | 15 |
| Presence of Family History of PsA (N=49) | 11 |
| Prior Methotrexate Use | 36 |
| Current Methotrexate Use | 11 |
| Prior Biologic Therapy | 14 |
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AbbVie (prior sponsor, Abbott)