- ICH GCP
- US Clinical Trials Registry
- 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 (TOGETHER)
April 27, 2015 updated by: AbbVie (prior sponsor, Abbott)
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barranquilla, Colombia
- Site Reference ID/Investigator# 48347
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Barranquilla, Colombia
- Site Reference ID/Investigator# 48349
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Barranquilla, Colombia
- Site Reference ID/Investigator# 53045
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Bogota, Colombia
- Site Reference ID/Investigator# 53047
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Bogota, Colombia
- Site Reference ID/Investigator# 78533
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Cali, Colombia
- Site Reference ID/Investigator# 48345
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Cali, Colombia
- Site Reference ID/Investigator# 48346
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Cali, Colombia
- Site Reference ID/Investigator# 59342
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Cartagena, Colombia
- Site Reference ID/Investigator# 48342
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Cartagena, Colombia
- Site Reference ID/Investigator# 48348
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Cartagena, Colombia
- Site Reference ID/Investigator# 53050
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Medellin, Colombia
- Site Reference ID/Investigator# 48351
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Medellin, Colombia
- Site Reference ID/Investigator# 48353
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Medellin, Colombia
- Site Reference ID/Investigator# 53046
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Medellin, Colombia
- Site Reference ID/Investigator# 53049
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants treated with adalimumab, per approved label, with moderate or severe plaque psoriasis
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Moderate or severe plaque psoriasis
Participants with moderate or severe plaque psoriasis treated with adalimumab
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Developed Psoriatic Arthritis (PsA)
Time Frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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A participant is said to have PsA if they meet the following criteria:
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At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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Percentage of Participants Who Developed Signs or Symptoms of PsA
Time Frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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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.
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At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Time to First Occurrence of PsA Signs or Symptoms
Time Frame: Baseline up to Visit 4 (month 12)
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The measure of time from Psoriasis diagnosis to the appearance of PsA signs or symptoms.
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Baseline up to Visit 4 (month 12)
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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)
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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).
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At Baseline, Visit 2 (month 2), Visit 3 (month 6) and Visit 4 (month 12)
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Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA
Time Frame: Baseline up to Visit 4 (month 12)
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Percentage of participants with comorbidities (metabolic syndrome, hypertension, diabetes, atherosclerosis, obesity, alcohol and other associated comorbidities) was assessed.
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Baseline up to Visit 4 (month 12)
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Mean Change in Quality of Life (QoL)
Time Frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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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.
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At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score
Time Frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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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.
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At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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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)
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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).
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At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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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)
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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.
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At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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Percentage of Participants With Joint Symptoms
Time Frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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Joint symptoms were evaluated by presence or absence of peripheral arthritis, morning stiffness and participant reported joint symptoms.
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At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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Incidence Rate of PsA Since Psoriasis Diagnosis
Time Frame: Baseline up to Visit 4 (month 12)
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The number of new PsA cases were determined by:
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Baseline up to Visit 4 (month 12)
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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
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This outcome measure was not calculated.
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At Baseline, Week 24, and Week 48
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Manuel G Uribe, Abbvie SAS
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
February 14, 2011
First Submitted That Met QC Criteria
March 15, 2011
First Posted (Estimate)
March 16, 2011
Study Record Updates
Last Update Posted (Estimate)
May 12, 2015
Last Update Submitted That Met QC Criteria
April 27, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P12-598
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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