N/A
N=52
Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment
Psoriasis · Psoriatic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01316224 ↗Enrolled (actual)
52
Serious AEs
30.8%
Results posted
May 2015
Primary outcome: Primary: Percentage of Participants Who Developed Psoriatic Arthritis (PsA) — 47.4; 35.7; 17.3; 10.3 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Developed Psoriatic Arthritis (PsA) |
47.4; 35.7; 17.3; 10.3; 3.6; 46.2 | — |
| PRIMARY Percentage of Participants Who Developed Signs or Symptoms of PsA |
61.2; 33.3; 25.0 | — |
| SECONDARY Mean Time to First Occurrence of PsA Signs or Symptoms |
23.17 | — |
| SECONDARY Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score |
17.42; -11.56; -13.12; -15.17 | — |
| SECONDARY Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA |
60.0; 52.6 | — |
| SECONDARY Mean Change in Quality of Life (QoL) |
78.46; -1.52; -0.95; 68.75; 6.52; 6.55 | — |
| SECONDARY Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score |
2.82; 0.05; -0.07 | — |
| SECONDARY Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist |
67.30; 64.10; 71.40 | — |
| SECONDARY Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero |
24.50; 12.80; 7.10; 36.70; 20.50; 14.30 | — |
| SECONDARY Percentage of Participants With Joint Symptoms |
61.20; 30.80; 25.00 | — |
| SECONDARY Incidence Rate of PsA Since Psoriasis Diagnosis |
2.66 | — |
| SECONDARY Change in the Subject Proportion That Achieved a PASI (Psoriasis Area and Severity Index) Reduction of ≥50% |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Participant has a documented clinical diagnosis of psoriasis, as determined by participant interview of his/her medical history and confirmation of diagnosis through physical examination by the investigator
- Participant has indication of psoriasis systemic therapy
- If female, participant is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
- Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
- Contraceptives (oral or parenteral) for three months (90 days) prior to study drug administration
- A vasectomized partner
- Total abstinence from sexual intercourse
- Able and willing to give written informed consent and comply with the requirements of the study protocol
Exclusion Criteria
- Participants who have active infections
- Participants enrolled in another study or clinical trial
- Any condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or participants to an unacceptable risk
- History of active tuberculosis (TB), histoplasmosis or listeriosis
Data sourced from ClinicalTrials.gov (NCT01316224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.