Clinical trial NCT01316224: Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment
Official title: Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Psoriatic Arthritis
Keywords: Psoriasis
Incidence
Quality of Life
Psoriatic Arthritis
Prevalence
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-03-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants treated with adalimumab, per approved label, with moderate or severe plaque psoriasis

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Percentage of Participants Who Developed Psoriatic Arthritis (PsA)
timeFrame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
measure: Percentage of Participants Who Developed Signs or Symptoms of PsA
timeFrame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
Secondary outcomes:
measure: Mean Time to First Occurrence of PsA Signs or Symptoms
timeFrame: Baseline up to Visit 4 (month 12)
measure: Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
timeFrame: At Baseline, Visit 2 (month 2), Visit 3 (month 6) and Visit 4 (month 12)
measure: Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA
timeFrame: Baseline up to Visit 4 (month 12)
measure: Mean Change in Quality of Life (QoL)
timeFrame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
measure: Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score
timeFrame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
measure: Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist
timeFrame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
measure: Percentage of Participants With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero
timeFrame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
measure: Percentage of Participants With Joint Symptoms
timeFrame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
measure: Incidence Rate of PsA Since Psoriasis Diagnosis
timeFrame: Baseline up to Visit 4 (month 12)
measure: Change in the Subject Proportion That Achieved a PASI (Psoriasis Area and Severity Index) Reduction of ≥50%
timeFrame: At Baseline, Week 24, and Week 48
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Site Reference ID/Investigator# 48347
city: Barranquilla
country: Colombia
facility: Site Reference ID/Investigator# 48349
city: Barranquilla
country: Colombia
facility: Site Reference ID/Investigator# 53045
city: Bogota
country: Colombia
facility: Site Reference ID/Investigator# 53047
city: Bogota
country: Colombia
facility: Site Reference ID/Investigator# 78533
city: Cali
country: Colombia
facility: Site Reference ID/Investigator# 48345
city: Cali
country: Colombia
facility: Site Reference ID/Investigator# 48346
city: Cali
country: Colombia
facility: Site Reference ID/Investigator# 59342
city: Cartagena
country: Colombia
facility: Site Reference ID/Investigator# 48342
city: Cartagena
country: Colombia
facility: Site Reference ID/Investigator# 48348
city: Cartagena
country: Colombia
facility: Site Reference ID/Investigator# 53050
city: Medellin
country: Colombia
facility: Site Reference ID/Investigator# 48351
city: Medellin
country: Colombia
facility: Site Reference ID/Investigator# 48353
city: Medellin
country: Colombia
facility: Site Reference ID/Investigator# 53046
city: Medellin
country: Colombia
facility: Site Reference ID/Investigator# 53049
Study officials:
affiliation: Abbvie SAS
name: Manuel G Uribe
role: STUDY_DIRECTOR
References: