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Completed

NCT Number: NCT01316224

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 48347, Barranquilla, Colombia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Who Developed Psoriatic Arthritis (PsA)

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

    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.

  2. Percentage of Participants Who Developed Signs or Symptoms of PsA

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

    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 outcomes

  1. Mean Time to First Occurrence of PsA Signs or Symptoms

    Time frame: Baseline up to Visit 4 (month 12)

    The measure of time from Psoriasis diagnosis to the appearance of PsA signs or symptoms.

  2. 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)

    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).

  3. Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA

    Time frame: Baseline up to Visit 4 (month 12)

    Percentage of participants with comorbidities (metabolic syndrome, hypertension, diabetes, atherosclerosis, obesity, alcohol and other associated comorbidities) was assessed.

  4. Mean Change in Quality of Life (QoL)

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

    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.

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

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

    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.

  6. 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)

    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).

  7. 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)

    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.

  8. Percentage of Participants With Joint Symptoms

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

    Joint symptoms were evaluated by presence or absence of peripheral arthritis, morning stiffness and participant reported joint symptoms.

  9. Incidence Rate of PsA Since Psoriasis Diagnosis

    Time frame: Baseline up to Visit 4 (month 12)

    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).

  10. 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

    This outcome measure was not calculated.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Acronym: TOGETHER

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 16, 2011
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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