PsoriasisTOGETHERNCT01316224
Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment
An observational study of Psoriasis and Psoriatic Arthritis, run by AbbVie (prior sponsor, Abbott) at 15 sites in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Psoriatic Arthritis
- How many people
- 52 participants
- Where
- 15 sitesColombia
- Study dates
- Apr 2011to Apr 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants treated with adalimumab, per approved label, with moderate or severe plaque psoriasis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Colombia15 sites
Site Reference ID/Investigator# 48347
Barranquilla
Site Reference ID/Investigator# 48349
Barranquilla
Site Reference ID/Investigator# 53045
Barranquilla
Site Reference ID/Investigator# 53047
Bogotá
Site Reference ID/Investigator# 78533
Bogotá
Site Reference ID/Investigator# 48345
Cali
Site Reference ID/Investigator# 48346
Cali
Site Reference ID/Investigator# 59342
Cali
Site Reference ID/Investigator# 48342
Cartagena
Site Reference ID/Investigator# 48348
Cartagena
Site Reference ID/Investigator# 53050
Cartagena
Site Reference ID/Investigator# 48351
Medellín
Site Reference ID/Investigator# 48353
Medellín
Site Reference ID/Investigator# 53046
Medellín
Site Reference ID/Investigator# 53049
Medellín
About this study
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.
Read the 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.
- Conditions
- Psoriasis, Psoriatic Arthritis
- Keywords
- Psoriasis, Incidence, Quality of Life, Psoriatic Arthritis, Prevalence
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Moderate or severe plaque psoriasis | Participants with moderate or severe plaque psoriasis treated with adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
Secondary outcomes (10)
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.
Measured: Baseline up to Visit 4 (month 12)
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).
Measured: 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
Percentage of participants with comorbidities (metabolic syndrome, hypertension, diabetes, atherosclerosis, obesity, alcohol and other associated comorbidities) was assessed.
Measured: Baseline up to Visit 4 (month 12)
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.
Measured: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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.
Measured: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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).
Measured: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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.
Measured: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
Percentage of Participants With Joint Symptoms
Joint symptoms were evaluated by presence or absence of peripheral arthritis, morning stiffness and participant reported joint symptoms.
Measured: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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).
Measured: Baseline up to Visit 4 (month 12)
Change in the Subject Proportion That Achieved a PASI (Psoriasis Area and Severity Index) Reduction of ≥50%
This outcome measure was not calculated.
Measured: At Baseline, Week 24, and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuel G Uribe, Study director, Abbvie SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316224
- Sponsor's protocol ID
- P12-598
- Acronym
- TOGETHER
- Status last verified
- Apr 2015
- First submitted
- 14 Feb 2011
- Last updated
- 12 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients With Psoriasis Severe or Moderate With Adalimumab Treatment
- ClinicalTrials.gov ID
- NCT01316224
- Acronym / sponsor ID
- TOGETHER / P12-598
- Conditions
- Psoriasis, Psoriatic Arthritis
- Keywords
- Psoriasis, Incidence, Quality of Life, Psoriatic Arthritis, Prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Posted 12 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate or severe plaque psoriasis | – | –Participants with moderate or severe plaque psoriasis treated with adalimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants treated with adalimumab, per approved label, with moderate or severe plaque psoriasis
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 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)
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.
10 secondary outcomes
Mean Time to First Occurrence of PsA Signs or Symptoms
Time frame: Baseline up to Visit 4 (month 12)
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)
Percentage of Participants With Comorbidities Who Did or Did Not Develop PsA
Time frame: Baseline up to Visit 4 (month 12)
Mean Change in Quality of Life (QoL)
Time frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
Mean Change in ClASsification Criteria for Psoriatic ARthritis (CASPAR) Score
Time frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
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)
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)
Percentage of Participants With Joint Symptoms
Time frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)
Incidence Rate of PsA Since Psoriasis Diagnosis
Time frame: Baseline up to Visit 4 (month 12)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel G Uribe study director
Abbvie SAS
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Psoriatic Arthritis, run by AbbVie (prior sponsor, Abbott) at 15 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Developed Psoriatic Arthritis (PsA) (time frame: At Baseline, Visit 3 (month 6) and Visit 4 (month 12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.