Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment

Psoriasis Clinical Trial

— TOGETHER  

Official title:

Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316224
• Other study ID #: P12-598
• Status: Completed
• Phase: N/A
• First received: February 14, 2011
• Last updated: April 27, 2015
• Start date: April 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis
• Psoriatic Arthritis
• Signs and Symptoms

Locations

Country	Name	City	State
Colombia	Site Reference ID/Investigator# 48347	Barranquilla
Colombia	Site Reference ID/Investigator# 48349	Barranquilla
Colombia	Site Reference ID/Investigator# 53045	Barranquilla
Colombia	Site Reference ID/Investigator# 53047	Bogota
Colombia	Site Reference ID/Investigator# 78533	Bogota
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	Medellin
Colombia	Site Reference ID/Investigator# 48353	Medellin
Colombia	Site Reference ID/Investigator# 53046	Medellin
Colombia	Site Reference ID/Investigator# 53049	Medellin

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Developed Psoriatic Arthritis (PsA)	A participant is said to have PsA if they meet the following criteria: PsA defined by a rheumatologist; or; A participant with inflamed joints >0 and CASPAR score >=3; or; Participant meeting at least one of the two previous definitions.	At Baseline, Visit 3 (month 6) and Visit 4 (month 12)	No
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.	At Baseline, Visit 3 (month 6) and Visit 4 (month 12)	No
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.	Baseline up to Visit 4 (month 12)	No
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).	At Baseline, Visit 2 (month 2), Visit 3 (month 6) and Visit 4 (month 12)	No
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.	Baseline up to Visit 4 (month 12)	No
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.	At Baseline, Visit 3 (month 6) and Visit 4 (month 12)	No
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.	At Baseline, Visit 3 (month 6) and Visit 4 (month 12)	No
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).	At Baseline, Visit 3 (month 6) and Visit 4 (month 12)	No
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.	At Baseline, Visit 3 (month 6) and Visit 4 (month 12)	No
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.	At Baseline, Visit 3 (month 6) and Visit 4 (month 12)	No
Secondary	Incidence Rate of PsA Since Psoriasis Diagnosis	The number of new PsA cases were determined by: PsA defined by a rheumatologist; or; A participant with inflamed joints >0 and CASPAR score >=3; or; 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).	Baseline up to Visit 4 (month 12)	No
Secondary	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	No

External Links

•   Link