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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01316224
First received: February 14, 2011
Last updated: April 27, 2015
Last verified: April 2015
  Purpose

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.


Condition
Psoriasis
Psoriatic Arthritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of Participants Who Developed Psoriatic Arthritis (PsA) [ Time Frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12) ] [ Designated as safety issue: No ]

    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 Who Developed Signs or Symptoms of PsA [ Time Frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Time to First Occurrence of PsA Signs or Symptoms [ Time Frame: Baseline up to Visit 4 (month 12) ] [ Designated as safety issue: No ]
    The measure of time from Psoriasis diagnosis to the appearance of PsA signs or symptoms.

  • Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [ Time Frame: At Baseline, Visit 2 (month 2), Visit 3 (month 6) and Visit 4 (month 12) ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA [ Time Frame: Baseline up to Visit 4 (month 12) ] [ Designated as safety issue: No ]
    Percentage of participants with comorbidities (metabolic syndrome, hypertension, diabetes, atherosclerosis, obesity, alcohol and other associated comorbidities) was assessed.

  • Mean Change in Quality of Life (QoL) [ Time Frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12) ] [ Designated as safety issue: No ]
    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.

  • Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score [ Time Frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With a CASPAR Score Greater Than or Equal to 3 at Each Visit to the Rheumatologist [ Time Frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12) ] [ Designated as safety issue: No ]
    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 With Swollen Joint Count (SJC) and Tender Joint Count (TJC) Greater Than Zero [ Time Frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12) ] [ Designated as safety issue: No ]
    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 With Joint Symptoms [ Time Frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12) ] [ Designated as safety issue: No ]
    Joint symptoms were evaluated by presence or absence of peripheral arthritis, morning stiffness and participant reported joint symptoms.

  • Incidence Rate of PsA Since Psoriasis Diagnosis [ Time Frame: Baseline up to Visit 4 (month 12) ] [ Designated as safety issue: No ]

    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).

  • Change in the Subject Proportion That Achieved a PASI (Psoriasis Area and Severity Index) Reduction of ≥50% [ Time Frame: At Baseline, Week 24, and Week 48 ] [ Designated as safety issue: No ]
    This outcome measure was not calculated.


Enrollment: 52
Study Start Date: April 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Moderate or severe plaque psoriasis
Participants with moderate or severe plaque psoriasis treated with adalimumab

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316224

Locations
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# 48346
Cali, Colombia
Site Reference ID/Investigator# 59342
Cali, Colombia
Site Reference ID/Investigator# 48345
Cali, Colombia
Site Reference ID/Investigator# 53050
Cartagena, Colombia
Site Reference ID/Investigator# 48348
Cartagena, Colombia
Site Reference ID/Investigator# 48342
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, Colombia
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Manuel G Uribe Abbvie SAS
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01316224     History of Changes
Other Study ID Numbers: P12-598
Study First Received: February 14, 2011
Results First Received: April 8, 2015
Last Updated: April 27, 2015
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by AbbVie:
Psoriasis
Incidence
Quality of Life
Psoriatic Arthritis
Prevalence

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Psoriasis
Signs and Symptoms
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015