Moderate to Severe Plaque PsoriasisNCT01202565
Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
An observational study of Moderate to Severe Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 73 sites in 8 countries.
Trial summary
There is clearly a need for further data on the efficacy of biologic agents in the treatment of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports can be found, but no published data exists from non-interventional studies, such as post-marketing observational studies (PMOS) that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- How many people
- 506 participants
- Where
- 73 sitesin 8 countries
- Study dates
- Sep 2010to Jul 2013
- 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: Per this PMOS protocol, the study population will consists of adult patients with moderate to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are intolerant of other systemic therapies including cyclosporine, methotrexate or PUVA (photochemotherapy combining psoralen with ultraviolet A treatment), and exhibit a significant psoriatic affection of the scalp and/or nails.
Who may be able to join
- Patients will be enrolled in this PMOS if they fulfill all of the below criteria:
- Patients with moderate to severe plaque psoriasis eligible for Humira therapy according to the local product label and prescription/reimbursement guidelines
- Have significant psoriatic nail affection (total Nail Psoriasis Severity Index NAPSI score of hands and feet ≥ 10) and/or significant psoriatic scalp affection (Psoriasis Scalp Severity Index PSSI score ≥ 10)
- Adult (≥18 years of age)
- Have negative result of tuberculosis (TB) screening test or TB prophylaxis as per local guidelines
- Willing to provide informed consent if requested by the local law regulations
Who cannot join
- Patients fulfilling any of the below exclusion criteria will not be eligible for this PMOS:
- Meet contraindications as outlined in the latest version of the local Summary of Product Characteristics (SmPC)
- Participate in another clinical/observational study
Trial locations and contacts
73 sites in 8 countries.
73 sites in 8 countries
Romania26 sites
Site Reference ID/Investigator# 46184
Alexandria, 140074
Site Reference ID/Investigator# 44580
Bucharest, 010825
Site Reference ID/Investigator# 44572
Bucharest, 011461
Site Reference ID/Investigator# 44575
Bucharest, 040215
Site Reference ID/Investigator# 44576
Bucharest, 040215
Site Reference ID/Investigator# 46185
Bucharest, 040215
Site Reference ID/Investigator# 44563
Bucharest, 72202
Site Reference ID/Investigator# 44564
Bucharest, 72202
Site Reference ID/Investigator# 44566
Bucharest, 72202
Site Reference ID/Investigator# 44567
Bucharest, 72202
Site Reference ID/Investigator# 44569
Bucharest, 72202
Site Reference ID/Investigator# 44571
Bucharest, 72202
Site Reference ID/Investigator# 30745
Cluj-Napoca, 400006
Site Reference ID/Investigator# 44561
Constanța, 900125
Site Reference ID/Investigator# 44562
Constanța, 900125
Site Reference ID/Investigator# 44557
Craiova, 200642
Site Reference ID/Investigator# 44558
Craiova, 200642
Site Reference ID/Investigator# 44559
Craiova, 200642
Site Reference ID/Investigator# 44560
Craiova, 200642
Site Reference ID/Investigator# 44547
Iași, 700368
Site Reference ID/Investigator# 44548
Iași, 700368
Site Reference ID/Investigator# 44549
Iași, 700506
Site Reference ID/Investigator# 46183
Oradea, 410167
Site Reference ID/Investigator# 44555
Ploieşti, 100379
Site Reference ID/Investigator# 44554
Reghin, 545300
Site Reference ID/Investigator# 44550
Târgu Mureş, 540136
Hungary15 sites
Site Reference ID/Investigator# 30743
Budapest, 1085
Site Reference ID/Investigator# 42506
Debrecen, 4032
Site Reference ID/Investigator# 42507
Debrecen, 4032
Site Reference ID/Investigator# 42508
Debrecen, 4032
Site Reference ID/Investigator# 42509
Debrecen, 4032
Site Reference ID/Investigator# 42510
Debrecen, 4032
Site Reference ID/Investigator# 42514
Kaposvár, 7400
Site Reference ID/Investigator# 42515
Kecskemét, 6000
Site Reference ID/Investigator# 42516
Miskolc, 3529
Site Reference ID/Investigator# 42511
Pécs, 7624
Site Reference ID/Investigator# 42512
Pécs, 7624
Site Reference ID/Investigator# 42513
Pécs, 7624
Site Reference ID/Investigator# 44854
Pécs, 7624
Site Reference ID/Investigator# 42502
Szeged, 6720
Site Reference ID/Investigator# 42517
Szombathely, 9700
Czechia8 sites
Site Reference ID/Investigator# 63776
Chotoviny, 391 32
Site Reference ID/Investigator# 58083
Jihlava, 58601
Site Reference ID/Investigator# 56762
Klimkovice, 74283
Site Reference ID/Investigator# 56763
Klimkovice, 74283
Site Reference ID/Investigator# 30742
Kostelec nad Ohří, 517 41
Site Reference ID/Investigator# 54503
Prague, 100 34
Site Reference ID/Investigator# 56542
Prague, 128 08
Site Reference ID/Investigator# 58084
Prague, 18081
Ukraine6 sites
Site Reference ID/Investigator# 64524
Donetsk, 83017
Site Reference ID/Investigator# 66642
Donetsk, 83087
Site Reference ID/Investigator# 62304
Kharkiv, 61036
Site Reference ID/Investigator# 56699
Kiev, 04107
Site Reference ID/Investigator# 55443
Lviv, 79015
Site Reference ID/Investigator# 70493
Lviv, 79018
Israel5 sites
Site Reference ID/Investigator# 30744
Afula, 18101
Site Reference ID/Investigator# 49888
Jerusalem, 9112001
Site Reference ID/Investigator# 49886
Petach Tiqwa, 49100
Site Reference ID/Investigator# 49887
Ramat Gan, 52621
Site Reference ID/Investigator# 51783
Tel Aviv, 64239
Slovakia5 sites
Site Reference ID/Investigator# 30746
Banská Bystrica, 975 17
Site Reference ID/Investigator# 42521
Bratislava, 813 69
Site Reference ID/Investigator# 42519
Košice, 040 66
Site Reference ID/Investigator# 42522
Martin, 036 59
Site Reference ID/Investigator# 42518
Prešov, 080 01
Estonia4 sites
Site Reference ID/Investigator# 57562
Tallinn, 13419
Site Reference ID/Investigator# 57563
Tallinn, 13419
Site Reference ID/Investigator# 57564
Tallinn, 13419
Site Reference ID/Investigator# 57567
Tartu, 50406
Slovenia4 sites
Site Reference ID/Investigator# 30747
Ljubljana, 1000
Site Reference ID/Investigator# 44544
Ljubljana, 1000
Site Reference ID/Investigator# 44542
Maribor, 2000
Site Reference ID/Investigator# 47702
Sežana, 6210
About this study
Official title: Effectiveness of Adalimumab (Humira) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
There is clearly a need for further data on the efficacy of biologic agents in the treatment of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports can be found, but no published data exists from non-interventional studies, such as post-marketing observational studies (PMOS) that reflect routine clinical practice.
The aim of this PMOS is to evaluate the long-term (12-month) efficacy of adalimumab in the treatment of nail and scalp psoriatic lesions in routine dermatologic practice.
Read the detailed description
This is post-marketing observational study (PMOS) in which HUMIRA® is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication, and following the local prescription and/or reimbursement guidance.
Follow-up visits are not strictly scheduled, but rather left to the judgment of each investigator within the 12-month study period for each participant. Five visits are indicated within the 12-month observational period: Baseline and follow-up at 3 months, 6 months, 9 months and at 12 months (Study End).
As nails are not included in the general measures of disease severity (such as Psoriasis Area and Severity Index [PASI]), the Nail Psoriasis Severity Index (NAPSI) will be used to assign a score of nail psoriasis. The scalp, though being involved in the general measures of disease severity (e.g. PASI), represents only 4-5% of the body surface and is therefore poorly represented. Psoriasis Scalp Severity Index (PSSI) will be used to quantify the intensity of scalp psoriasis and its changes during the study. The association between general skin and localized nail and scalp, and changes in quality of life in response to adalimumab therapy will also be examined.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Keywords
- Post-marketing observational study (PMOS) Protocol, Moderate to Severe Plaque Psoriasis, Treatment of Scalp and Nail Affection, Effectiveness of Adalimumab (HUMIRA®)
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 |
|---|---|---|
| Adalimumab | Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12
NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:
- 0 = none;
- 1 = present in 1/4 nail quadrants;
- 2 = present in 2/4 nail quadrants;
- 3 = present in 3/4 nail quadrants;
- 4 = present in 4/4 nail quadrants.
The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).
Change from Baseline is presented as a percentage of the Baseline value, calculated as: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.
Measured: Baseline and Month 12
Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12
The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.
Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.
Measured: Baseline and Month 12
Secondary outcomes (18)
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:
- 0 = none;
- 1 = present in 1/4 nail quadrants;
- 2 = present in 2/4 nail quadrants;
- 3 = present in 3/4 nail quadrants;
- 4 = present in 4/4 nail quadrants.
The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).
A negative change from Baseline indicates improvement.
Measured: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis
Good clinical response on nails is defined as ≥ 50% improvement from Baseline in total NAPSI score.
The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:
- 0 = none;
- 1 = present in 1/4 nail quadrants;
- 2 = present in 2/4 nail quadrants;
- 3 = present in 3/4 nail quadrants;
- 4 = present in 4/4 nail quadrants.
The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).
Measured: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving Complete Clearing of Nails
Complete clearing of nails is defined as a total NAPSI score of zero.
The NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:
- 0 = none;
- 1 = present in 1/4 nail quadrants;
- 2 = present in 2/4 nail quadrants;
- 3 = present in 3/4 nail quadrants;
- 4 = present in 4/4 nail quadrants.
The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants).
Measured: Months 3, 6, 9, and 12
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area. A negative change from Baseline indicates improvement.
Measured: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving Good Clinical Response on Scalp
Good clinical response on scalp is defined as a ≥ 50% improvement from Baseline in PSSI score.
The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.
Measured: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving Complete Clearing of Scalp
Complete clearing on scalp is defined as a PSSI score of zero. The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area.
Measured: Months 3, 6, 9, and 12
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.
Measured: Baseline and Month 12
Change From Baseline in PASI Score
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. A negative change from Baseline indicates improvement.
Measured: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving a PASI 90 Response
The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Measured: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving a PASI 75 Response
The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Measured: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving a PASI 50 Response
The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline.
PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Measured: Baseline and Months 3, 6, 9, and 12
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.
Measured: Baseline and Month 12
Change From Baseline in DLQI Score
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.
Measured: Baseline and Months 3, 6, 9, and 12
Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis
Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Measured: Baseline and Month 12
Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis
Associations between general improvement in psoriasis, measured by percentage change of PASI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Measured: Baseline and Month 12
Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis
Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of nail psoriasis at the same time, measured by percentage improvement of the NAPSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Measured: Baseline and Month 12
Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis
Associations between general improvement in quality of life, measured by percentage change of DLQI, and the improvement of scalp psoriasis at the same time, measured by percentage improvement of the PSSI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Measured: Baseline and Month 12
Associations Between General Improvement in Psoriasis With Improvement in Quality of Life
Associations between general improvement in quality of life, measured by percentage change of DLQI, and general improvement in psoriasis at the same time, measured by percentage improvement of the PASI, were evaluated by means of Spearman's rank correlation coefficient. Generally, correlation coefficients below 0.2 are considered as no or only weak association, between 0.2 and 0.5 as moderate association, between 0.5 and 0.8 as strong association and above 0.8 as very strong associations.
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2013
- Study completionJul 2013
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 Moderate to Severe Plaque 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
- Time perspective
- Prospective
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaka Brumen, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202565
- Sponsor's protocol ID
- P12-165
- Status last verified
- Jul 2014
- First submitted
- 14 Sep 2010
- Last updated
- 7 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adalimumab (Humira) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT01202565
- Acronym / sponsor ID
- P12-165
- Conditions
- Moderate to Severe Plaque Psoriasis
- Keywords
- Post-marketing observational study (PMOS) Protocol, Moderate to Severe Plaque Psoriasis, Treatment of Scalp and Nail Affection, Effectiveness of Adalimumab (HUMIRA®)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Posted 7 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is clearly a need for further data on the efficacy of biologic agents in the treatment of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports can be found, but no published data exists from non-interventional studies, such as post-marketing observational studies (PMOS) that reflect routine clinical practice.
The aim of this PMOS is to evaluate the long-term (12-month) efficacy of adalimumab in the treatment of nail and scalp psoriatic lesions in routine dermatologic practice.
Detailed description
This is post-marketing observational study (PMOS) in which HUMIRA® is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication, and following the local prescription and/or reimbursement guidance.
Follow-up visits are not strictly scheduled, but rather left to the judgment of each investigator within the 12-month study period for each participant. Five visits are indicated within the 12-month observational period: Baseline and follow-up at 3 months, 6 months, 9 months and at 12 months (Study End).
As nails are not included in the general measures of disease severity (such as Psoriasis Area and Severity Index [PASI]), the Nail Psoriasis Severity Index (NAPSI) will be used to assign a score of nail psoriasis. The scalp, though being involved in the general measures of disease severity (e.g. PASI), represents only 4-5% of the body surface and is therefore poorly represented. Psoriasis Scalp Severity Index (PSSI) will be used to quantify the intensity of scalp psoriasis and its changes during the study. The association between general skin and localized nail and scalp, and changes in quality of life in response to adalimumab therapy will also be examined.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | – | –Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Per this PMOS protocol, the study population will consists of adult patients with moderate to severe plaque psoriasis who have failed to respond to, have a contraindication to, or are intolerant of other systemic therapies including cyclosporine, methotrexate or PUVA (photochemotherapy combining psoralen with ultraviolet A treatment), and exhibit a significant psoriatic affection of the scalp and/or nails.
Key inclusion criteria (6 listed)
- Patients with moderate to severe plaque psoriasis eligible for Humira therapy according to the local product label and prescription/reimbursement guidelines
- Have significant psoriatic nail affection (total Nail Psoriasis Severity Index NAPSI score of hands and feet ≥ 10) and/or significant psoriatic scalp affection (Psoriasis Scalp Severity Index PSSI score ≥ 10)
- Adult (≥18 years of age)
- Have negative result of tuberculosis (TB) screening test or TB prophylaxis as per local guidelines
- Willing to provide informed consent if requested by the local law regulations
Key exclusion criteria (3 listed)
- Patients fulfilling any of the below exclusion criteria will not be eligible for this PMOS:
- Meet contraindications as outlined in the latest version of the local Summary of Product Characteristics (SmPC)
- Participate in another clinical/observational study
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
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12
Time frame: Baseline and Month 12
NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The sum of these two scores is the total score for that nail. Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale: * 0 = none; * 1 = present in 1/4 nail quadrants; * 2 = present in 2/4 nail quadrants; * 3 = present in 3/4 nail quadrants; * 4 = present in 4/4 nail quadrants. The 2 most affected nails on either hands or feet were evaluated and summed for a score ranging from 0 (no nail psoriasis) to 16 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.
Percent Change From Baseline in Psoriasis Scalp Severity Index (PSSI) to Month 12
Time frame: Baseline and Month 12
The PSSI consists of two parts: an assessment of scalp area involved and an assessment of the 3 clinical symptoms erythema, induration and desquamation. Involved scalp area is measured on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved), clinical symptoms are each rated from 0 (absent) to 4 (severest possible). The composite score ranges from 0 (best) to 72 (worst) and is derived from the sum of symptom scores multiplied by the score of involved scalp area. Change from Baseline is presented as a percentage of the Baseline value: Month 12 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.
18 secondary outcomes
Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Time frame: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving a Good Clinical Response on Nail Psoriasis
Time frame: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving Complete Clearing of Nails
Time frame: Months 3, 6, 9, and 12
Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
Time frame: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving Good Clinical Response on Scalp
Time frame: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving Complete Clearing of Scalp
Time frame: Months 3, 6, 9, and 12
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
Time frame: Baseline and Month 12
Change From Baseline in PASI Score
Time frame: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving a PASI 90 Response
Time frame: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving a PASI 75 Response
Time frame: Baseline and Months 3, 6, 9, and 12
Percentage of Participants Achieving a PASI 50 Response
Time frame: Baseline and Months 3, 6, 9, and 12
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Time frame: Baseline and Month 12
Change From Baseline in DLQI Score
Time frame: Baseline and Months 3, 6, 9, and 12
Associations Between General Improvement in Psoriasis With Improvement in Nail Psoriasis
Time frame: Baseline and Month 12
Associations Between General Improvement in Psoriasis With Improvement in Scalp Psoriasis
Time frame: Baseline and Month 12
Associations Between Improvement in Quality of Life With Improvement in Nail Psoriasis
Time frame: Baseline and Month 12
Associations Between Improvement in Quality of Life With Improvement in Scalp Psoriasis
Time frame: Baseline and Month 12
Associations Between General Improvement in Psoriasis With Improvement in Quality of Life
Time frame: Baseline and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- 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.
Jaka Brumen study director
AbbVie
73 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate to Severe Plaque Psoriasis, run by AbbVie (prior sponsor, Abbott) at 73 sites in 8 countries.
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 6 inclusion and 3 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 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in Romania, Hungary, Czechia, Ukraine, Israel and 3 more countries. 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 7 Aug 2014). 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?
Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI) to Month 12 (time frame: Baseline and 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 7 Aug 2014.