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

NCT01316224 | Completed Results

• 1 other identifier: P12-598
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 15

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.

Conditions

Psoriasis; Psoriatic Arthritis

Keywords

Psoriasis; Incidence; Quality of Life; Psoriatic Arthritis; Prevalence

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

Secondary Outcomes (10)

• Mean Time to First Occurrence of PsA Signs or Symptoms

  Baseline up to Visit 4 (month 12)

• Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score

  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

  Baseline up to Visit 4 (month 12)

• Mean Change in Quality of Life (QoL)

  At Baseline, Visit 3 (month 6) and Visit 4 (month 12)

• Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score

  At Baseline, Visit 3 (month 6) and Visit 4 (month 12)

Study Arms (1)

Moderate or severe plaque psoriasis

Participants with moderate or severe plaque psoriasis treated with adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants treated with adalimumab, per approved label, with moderate or severe plaque psoriasis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (15)

Site Reference ID/Investigator# 48347

Barranquilla, Colombia

Location

Site Reference ID/Investigator# 48349

Barranquilla, Colombia

Location

Site Reference ID/Investigator# 53045

Barranquilla, Colombia

Location

Site Reference ID/Investigator# 53047

Bogotá, Colombia

Location

Site Reference ID/Investigator# 78533

Bogotá, Colombia

Location

Site Reference ID/Investigator# 48345

Cali, Colombia

Location

Site Reference ID/Investigator# 48346

Cali, Colombia

Location

Site Reference ID/Investigator# 59342

Cali, Colombia

Location

Site Reference ID/Investigator# 48342

Cartagena, Colombia

Location

Site Reference ID/Investigator# 48348

Cartagena, Colombia

Location

Site Reference ID/Investigator# 53050

Cartagena, Colombia

Location

Site Reference ID/Investigator# 48351

Medellín, Colombia

Location

Site Reference ID/Investigator# 48353

Medellín, Colombia

Location

Site Reference ID/Investigator# 53046

Medellín, Colombia

Location

Site Reference ID/Investigator# 53049

Medellín, Colombia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Manuel G Uribe

  Abbvie SAS

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: March 16, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 12, 2015
• Results First Posted: May 12, 2015

Record last verified: 2015-04

Locations

CO (15)