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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Romania

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

Other trials in Hungary

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

Other trials in Czechia

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

Other trials in Ukraine

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

Other trials in Israel

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

Other trials in Slovakia

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

Other trials in Estonia

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

Other trials in Slovenia

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.

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 groups in NCT01202565
Study groupRoleWhat they receive
AdalimumabParticipants 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.

  1. 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

  2. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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.

  1. First posted16 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

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)
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
Data monitoring committee
No

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?

On the ClinicalTrials.gov record for NCT01202565.

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; AzTrials last refreshed its copy on 8 Nov 2026.

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