PsoriasisPhase 4NCT01265823
Immediate Response With Adalimumab and Its Impact on Quality of Life and Other Comorbidity Factors in Patients With Moderate to Severe Plaque Psoriasis
A Phase 4 study testing Adalimumab in people with Psoriasis, run by AbbVie (prior sponsor, Abbott) at 8 sites in Mexico.
Trial summary
W11-050 is a Mexican open label multicenter study that has been designed to further assess the safety and efficacy of adalimumab in the treatment of patients with active plaque psoriasis who have failed prior conventional systemic psoriasis treatment or who are candidates for systemic therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 8 sitesMexico
- Study dates
- Oct 2010to Feb 2012
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to give written informed consent prior to any study related procedures and to comply with the requirements of the study protocol
- Male and female subjects between 18 and 75 years old
- Diagnosis of moderate to severe types I and II plaque psoriasis (Type I : symptoms onset before 40 years old; Type II: symptoms onset after 40 years old), with at least 6 months of duration
- Documented moderate to severe plaque psoriasis based on Psoriasis Area and Severity Index (PASI) score >10
- Subjects naïve to adalimumab therapy
- Subject must be evaluated for active and latent tuberculosis (TB) infection by using a Purified Protein Derivative (PPD) skin test, chest x-ray (posterior to anterior (PA) and lateral views) and a detailed review of the subject's medical history. This screening must be negative
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- A negative pregnancy test (serum human chorionic gonadotrophin) for women of childbearing potential prior to start of study treatment. (Non-childbearing potential is defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy])
- Able and willing to self-administer subcutaneous injections or have available a suitable person to administer subcutaneous injections
- Subject is judged to be in generally good health as determined by the investigator
Who cannot join
- Prior treatment with any investigational agent within 30 days, or five half-lives of the product, which ever is longer. Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half lives (whichever is longer) of the drug prior to study entry (Baseline Visit)
- Subject has other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with the evaluation of psoriasis or compromise the subject's safety
- Subject has a history of dysplasia, malignancy (including lymphoma and leukemia), or lymphoproliferative disease other than: a. Successfully and completely treated non-metastatic squamous or basal cell carcinoma of the skin with no recurrence within the last five years. b. Localized carcinoma in situ of the cervix or cervical dysplasia, with no recurrence within the last five years
- Persistent or recurrent infections or severe infections requiring hospitalization or treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days, or oral antibiotics, oral antivirals or oral antifungals within 14 days prior to Baseline Visit
- Other medical conditions: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure New York Heart Association (NYHA) III-IV, recent stroke (within three months), chronic leg ulcer and any other condition (e.g., indwelling urinary catheter) which, in the opinion of the investigator, may place the subject at risk
- Previous diagnosis or signs highly indicative of central nervous system demyelinating diseases (e.g., optic neuritis, ataxia, apraxia)
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- History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB
- Female subjects who are pregnant or breast-feeding
- History of clinically significant drug or alcohol abuse in the last year
- Subject started receiving a new topical therapy within the last four weeks prior to the Baseline visit for areas other than the palms, soles of feet, axilla and groin
- Subject started being treated with ultraviolet B (UVB) phototherapy, within the last four weeks prior to the Baseline visit
- Subject was treated with psoralen ultraviolet A (PUVA) phototherapy within the last four weeks prior to the Baseline visit
- Subject has been initiated on a new systemic agent within the last four weeks prior to the Baseline visit
- Patients with history of atopy
- Patients with any other autoimmune disease such as systemic lupus erythematosus (SLE) , Sdx Sjögren, vasculitis etc
- Known hypersensitivity to the excipients of adalimumab as stated in the label
- Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Subject with any prior exposure to Tysabri (natalizumab), or Orencia (abatacept)
- Subjects with positive immunologic test for hepatitis A, B or C (Positive test of any of the following: hepatitis A viral antibody immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab)
- Subjects with a positive immunologic test for HIV determined by enzyme-linked immunosorbent assay (ELISA) method
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Mexico8 sites
Site Reference ID/Investigator# 50942
Circuito Comercial Satelite
Site Reference ID/Investigator# 40964
Iztapalapa, 04230
Site Reference ID/Investigator# 50943
Mexico City, 06780
Site Reference ID/Investigator# 40965
Monterrey, 64460
Site Reference ID/Investigator# 40962
Monterrey, 64718
Site Reference ID/Investigator# 40662
Toluca, 50120
Site Reference ID/Investigator# 41062
Toluca, 50120
Site Reference ID/Investigator# 40963
Zapopan, 45190
About this study
W11-050 is a Mexican open label multicenter study that has been designed to further assess the safety and efficacy of adalimumab in the treatment of patients with active plaque psoriasis who have failed prior conventional systemic psoriasis treatment or who are candidates for systemic therapy.
Read the detailed description
Up to 150 subjects having a diagnosis of active plaque psoriasis and fulfilling the study eligibility criteria were enrolled in Mexico. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at week 1 until week 15). The study drug was self administered via subcutaneous (sc) injection. Safety and efficacy measures were performed throughout the study.
- Conditions
- Psoriasis
- Being tested
- Adalimumab
- Keywords
- Humira, Adalimumab, Plaque Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabBiological
Also called ABT-D2E7, Humira
Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | Not described Receives: Biological: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 4. The improvement in PASI score was used as a measure of efficacy.
Measured: Week 4
Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy.
Measured: Week 16
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 4
Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.
Measured: Week 4
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 16
Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.
Measured: Week 16
Secondary outcomes (18)
Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4
Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Measured: Baseline, Week 4
Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 16
Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Measured: Baseline, Week 16
Dermatology Life Quality Index (DLQI) Categories at Week 4
Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.
Measured: Week 4
Dermatology Life Quality Index (DLQI) Categories at Week 16
Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.
Measured: Week 16
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.
Measured: Week 4
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.
Measured: Week 16
Physician's Global Assessment (PGA) at Week 4
The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present).
Measured: Week 4
Physician's Global Assessment (PGA) at Week 16
The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present). The number of participants who achieve a PGA of 'clear' or 'almost clear' at Week 16 was a secondary outcome measure in this study.
Measured: Week 16
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16
Normal values: C-reactive protein (CRP) 0-0.79 mg/dL; cholesterol 30-199 mg/dL; high density lipoprotein (HDL) 40-100 mg/dL; very low density lipoprotein (VLDL) 0-34 mg/dL; low density lipoprotein (LDL) 20-99 mg/dL; triglycerides 50-149 mg/dL.
Measured: Baseline, Week 16
Mean Homocysteine Levels at Baseline and Week 16
Normal values for homocysteine were 5-13.9 µmol/L.
Measured: Baseline, Week 16
Percentage of Obese vs. Non-obese (Per Body Mass Index [BMI]) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16
The Body Mass Index (BMI) was used to determine the groups of participants who were overweight and who were considered obese. A BMI of 18.5 to 25 was considered normal range, 25 to 30 as overweight and 30 and above as obesity, in both men and women. Response to treatment in participants with obesity (based on Body Mass Index) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).
Measured: Week 16
Percentage of Obese vs. Non-obese (Per Waist-Hip Ratio) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16
The Waist-Hip Ratio was used to determine the groups of participants who were overweight and who were considered obese. Obesity was defined as a ratio of >1 for men and >0.8 for women. Response to treatment in participants with obesity (based on Waist-Hip Ratio) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).
Measured: Week 16
Serum Levels of Folic Acid at Baseline and Week 4
Normal values for folic acid were 3-15 ng/mL.
Measured: Baseline, Week 4
Serum Levels of Vitamin B6 at Baseline and Week 4
Normal values for vitamin B6 were 18-175 nmol/L.
Measured: Baseline, Week 4
Serum Levels of Vitamin B12 at Baseline and Week 4
Normal values for vitamin B12 were 200-1100 pg/mL.
Measured: Baseline, Week 4
Serum Levels of Folic Acid at Baseline and Week 16
Normal values for folic acid were 3-15 ng/mL.
Measured: Baseline, Week 16
Serum Levels of Vitamin B6 at Baseline and Week 16
Normal values for vitamin B6 were 18-175 nmol/L.
Measured: Baseline, Week 16
Serum Levels of Vitamin B12 at Baseline and Week 16
Normal values for vitamin B12 were 200-1100 pg/mL.
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2012
- Study completionFeb 2012
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose-Luis Canadas, Medical Director, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265823
- Sponsor's protocol ID
- W11-050
- Status last verified
- Feb 2013
- First submitted
- 22 Dec 2010
- Last updated
- 11 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Response With Adalimumab and Its Impact on Quality of Life and Other Comorbidity Factors in Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT01265823
- Acronym / sponsor ID
- W11-050
- Conditions
- Psoriasis
- Keywords
- Humira, Adalimumab, Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Posted 11 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
W11-050 is a Mexican open label multicenter study that has been designed to further assess the safety and efficacy of adalimumab in the treatment of patients with active plaque psoriasis who have failed prior conventional systemic psoriasis treatment or who are candidates for systemic therapy.
Detailed description
Up to 150 subjects having a diagnosis of active plaque psoriasis and fulfilling the study eligibility criteria were enrolled in Mexico. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at week 1 until week 15). The study drug was self administered via subcutaneous (sc) injection. Safety and efficacy measures were performed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Biological: Adalimumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able and willing to give written informed consent prior to any study related procedures and to comply with the requirements of the study protocol
- Male and female subjects between 18 and 75 years old
- Diagnosis of moderate to severe types I and II plaque psoriasis (Type I : symptoms onset before 40 years old; Type II: symptoms onset after 40 years old), with at least 6 months of duration
- Documented moderate to severe plaque psoriasis based on Psoriasis Area and Severity Index (PASI) score >10
- Subjects naïve to adalimumab therapy
Key exclusion criteria (21 listed)
- Prior treatment with any investigational agent within 30 days, or five half-lives of the product, which ever is longer. Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half lives (whichever is longer) of the drug prior to study entry (Baseline Visit)
- Subject has other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with the evaluation of psoriasis or compromise the subject's safety
- Subject has a history of dysplasia, malignancy (including lymphoma and leukemia), or lymphoproliferative disease other than: a. Successfully and completely treated non-metastatic squamous or basal cell carcinoma of the skin with no recurrence within the last five years. b. Localized carcinoma in situ of the cervix or cervical dysplasia, with no recurrence within the last five years
- Persistent or recurrent infections or severe infections requiring hospitalization or treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days, or oral antibiotics, oral antivirals or oral antifungals within 14 days prior to Baseline Visit
- Other medical conditions: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure New York Heart Association (NYHA) III-IV, recent stroke (within three months), chronic leg ulcer and any other condition (e.g., indwelling urinary catheter) which, in the opinion of the investigator, may place the subject at risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: ABT-D2E7, HumiraAdalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection. | Biological | Adalimumab |
Primary outcome
Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4
Time frame: Week 4
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 4. The improvement in PASI score was used as a measure of efficacy.
Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 16
Time frame: Week 16
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy.
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 4
Time frame: Week 4
Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 16
Time frame: Week 16
Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.
18 secondary outcomes
Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4
Time frame: Baseline, Week 4
Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 16
Time frame: Baseline, Week 16
Dermatology Life Quality Index (DLQI) Categories at Week 4
Time frame: Week 4
Dermatology Life Quality Index (DLQI) Categories at Week 16
Time frame: Week 16
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4
Time frame: Week 4
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16
Time frame: Week 16
Physician's Global Assessment (PGA) at Week 4
Time frame: Week 4
Physician's Global Assessment (PGA) at Week 16
Time frame: Week 16
Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16
Time frame: Baseline, Week 16
Mean Homocysteine Levels at Baseline and Week 16
Time frame: Baseline, Week 16
Percentage of Obese vs. Non-obese (Per Body Mass Index [BMI]) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16
Time frame: Week 16
Percentage of Obese vs. Non-obese (Per Waist-Hip Ratio) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16
Time frame: Week 16
Serum Levels of Folic Acid at Baseline and Week 4
Time frame: Baseline, Week 4
Serum Levels of Vitamin B6 at Baseline and Week 4
Time frame: Baseline, Week 4
Serum Levels of Vitamin B12 at Baseline and Week 4
Time frame: Baseline, Week 4
Serum Levels of Folic Acid at Baseline and Week 16
Time frame: Baseline, Week 16
Serum Levels of Vitamin B6 at Baseline and Week 16
Time frame: Baseline, Week 16
Serum Levels of Vitamin B12 at Baseline and Week 16
Time frame: Baseline, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2013.
- 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.
Jose-Luis Canadas, Medical Director, MD study director
AbbVie
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab in people with Psoriasis, run by AbbVie (prior sponsor, Abbott) at 8 sites in Mexico.
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 9 inclusion and 21 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 11 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Mexico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2013). 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 With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4 (time frame: Week 4). The study lists 4 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 11 Mar 2013; AzTrials last refreshed its copy on 6 Nov 2026.