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The purpose of this study is to determine the safety and efficacy of the use of the combination therapy adalimumab (ADA) every other week (EOW) with methotrexate (MTX) in suboptimal responders to ADA monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab Plus Methotrexate | Experimental | Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | Administered by subcutaneous injection every other week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment | Study investigators were asked to complete the following questionnaire at week 16: Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses. | Week 16 |
| Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Patient Self-assessment | Participants were asked to complete the following questionnaire at week 16: Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time | Study investigators were asked to complete the following questionnaire at each scheduled visit: Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses. |
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Inclusion Criteria:
Exclusion Criteria:
Subject has any contraindications to MTX or ADA;
Subject has a previous failed response or poor tolerance to ADA;
Subject has a poorly controlled medical condition which, in the opinion of the Investigator, would put the subject at risk by participation in the study;
Subject has a history of clinically significant hematologic, renal or liver disease;
Subject has a history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease and/or diagnosis of central demyelinating disease;
Subject has evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix;
Subject has a history of listeriosis, histoplasmosis, untreated TB, persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous (iv) anti-infectives within 30 days or oral anti-infectives within 14 days prior to the Baseline visit;
Subject is known to have immune deficiency, history of human immunodeficiency virus (HIV) or is immunocompromised;
Subject currently uses or plans to use anti-retroviral therapy at any time during the study;
Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study or for 150 days after the last dose of study medication;
Subject has a history of clinically significant drug or alcohol usage in the last year or cannot maintain an alcohol intake of 30 g a day or less throughout the study (one standard drink is defined as 180 mL/6 oz (approx. 10 g) of wine, 360 mL/12 oz (approx. 15 g) of regular beer, or 45 mL/1.5 oz (approx. 10 g) of spirits;
Screening clinical laboratory analyses show any of the following abnormal laboratory results:
Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study;
The following treatments are prohibited for all subjects during the study:
Prior exposure to biologics that have a potential or known association with progressive multifocal leukoencephalopathy (PML), i.e., natalizumab (Tysabri®) or rituximab (Rituxan®);
Subjects with any active viral infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study;
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| Name | Affiliation | Role |
|---|---|---|
| Marc-André Raymond, PhD | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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This study enrolled participants who in the opinion of the Investigator were not responding optimally to adalimumab monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) or who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders).
This single-arm, open-label longitudinal study was conducted at 12 sites in Canada from 5 August 2014 to 17 March 2017. The study entailed a screening period up to 35 days, a 24-week treatment period, and a 70-day safety follow-up period. Participants continued to receive adalimumab (ADA) and had oral methotrexate (MTX) added to their treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab + Methotrexate | Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Sub-optimal Responders - ADA + MTX | Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment | Study investigators were asked to complete the following questionnaire at week 16: Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses. | Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values at week 16 were categorized as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
|
From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adalimumab + Methotrexate | Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MEDDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MEDDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 22, 2016 | Feb 2, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 29, 2017 | Feb 2, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Methotrexate | Drug | Methotrexate was provided as 2.5 mg tablets for oral administration. |
|
| Baseline, week 8 and week 24 |
| Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time | Participants were asked to complete the following questionnaire at each scheduled visit: Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses. | Baseline, week 8 and week 24 |
| Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time | Study investigators were asked to complete the following questionnaire at each scheduled visit: Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:
| Baseline, weeks 8, 16, and 24 |
| Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time | Participants were asked to complete the following questionnaire at each scheduled visit: Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:
| Baseline, weeks 8, 16, and 24 |
| Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time | 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 PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 50 response is defined as at least a 50% reduction (improvement) from baseline in PASI score. | Baseline and Weeks 8, 16, and 24 |
| Percentage of Participants Who Achieved a PASI 75 Response Over Time | 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 PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from baseline in PASI score. | Baseline and Weeks 8, 16, and 24 |
| Percentage of Participants Who Achieved a PASI 90 Response Over Time | 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 PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is defined as at least a 90% reduction (improvement) from baseline in PASI score. | Baseline and Weeks 8, 16, and 24 |
| Percentage of Participants Who Achieved a PASI 100 Response Over Time | 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 PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 100 response is defined as a 100% reduction (improvement) from baseline in PASI score. | Baseline and Weeks 8, 16, and 24 |
| Change From Baseline in PASI Score Over Time | 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 PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). | Baseline and weeks 8, 16, and 24 |
| Percent Change From Baseline in PASI Score | 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 PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). | Baseline and weeks 8, 16, and 24 |
| Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of Cleared or Minimal Over Time | The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories:
The percentage of participants achieving a score of clear (0) or minimal (1) is reported. | Weeks 8, 16, and 24 |
| Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis | The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area. A decrease in BSA affected by psoriasis indicates improvement. | Baseline and weeks 8, 16, and 24 |
| Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis | The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area. A decrease in BSA affected by psoriasis indicates improvement. | Baseline and weeks 8, 16, and 24 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | 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. | Baseline, weeks 8, 16, and 24 |
| Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | 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. | Baseline, weeks 8, 16, and 24 |
| Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Over Time | 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. | Baseline and Weeks 8, 16, and 24 |
| Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 24 | Baseline and week 24 |
| Secondary Sub-optimal Responders - ADA + MTX |
Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Duration of Psoriasis | Mean | Standard Deviation | years |
|
| OG001 | Secondary Sub-optimal Responders - ADA + MTX | Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks. |
| OG002 | Adalimumab + Methotrexate | Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks. |
|
|
| Primary | Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Patient Self-assessment | Participants were asked to complete the following questionnaire at week 16: Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses. | Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values at week 16 were categorized as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 16 |
|
|
|
| Secondary | Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time | Study investigators were asked to complete the following questionnaire at each scheduled visit: Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses. | Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, week 8 and week 24 |
|
|
|
| Secondary | Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time | Participants were asked to complete the following questionnaire at each scheduled visit: Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:
Satisfaction with therapy was defined by the combination of highly or completely satisfied responses. | Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, week 8 and week 24 |
|
|
|
| Secondary | Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time | Study investigators were asked to complete the following questionnaire at each scheduled visit: Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:
| Participants who received at least one dose of ADA and one dose of MTX with available data at each time point. | Posted | Count of Participants | Participants | Baseline, weeks 8, 16, and 24 |
|
|
|
| Secondary | Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time | Participants were asked to complete the following questionnaire at each scheduled visit: Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:
| Participants who received at least one dose of ADA and one dose of MTX and with available data at each time point.. | Posted | Count of Participants | Participants | Baseline, weeks 8, 16, and 24 |
|
|
|
| Secondary | Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time | 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 PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 50 response is defined as at least a 50% reduction (improvement) from baseline in PASI score. | Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Weeks 8, 16, and 24 |
|
|
|
| Secondary | Percentage of Participants Who Achieved a PASI 75 Response Over Time | 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 PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from baseline in PASI score. | Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Weeks 8, 16, and 24 |
|
|
|
| Secondary | Percentage of Participants Who Achieved a PASI 90 Response Over Time | 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 PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is defined as at least a 90% reduction (improvement) from baseline in PASI score. | Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Weeks 8, 16, and 24 |
|
|
|
| Secondary | Percentage of Participants Who Achieved a PASI 100 Response Over Time | 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 PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 100 response is defined as a 100% reduction (improvement) from baseline in PASI score. | Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Weeks 8, 16, and 24 |
|
|
|
| Secondary | Change From Baseline in PASI Score Over Time | 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 PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). | Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and weeks 8, 16, and 24 |
|
|
|
| Secondary | Percent Change From Baseline in PASI Score | 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 PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). | Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and weeks 8, 16, and 24 |
|
|
|
| Secondary | Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of Cleared or Minimal Over Time | The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories:
The percentage of participants achieving a score of clear (0) or minimal (1) is reported. | Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 8, 16, and 24 |
|
|
|
| Secondary | Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis | The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area. A decrease in BSA affected by psoriasis indicates improvement. | Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used. | Posted | Least Squares Mean | Standard Error | percentage of body surface area | Baseline and weeks 8, 16, and 24 |
|
|
|
| Secondary | Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis | The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area. A decrease in BSA affected by psoriasis indicates improvement. | Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and weeks 8, 16, and 24 |
|
|
|
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | 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. | Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, weeks 8, 16, and 24 |
|
|
|
| Secondary | Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time | 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. | Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, weeks 8, 16, and 24 |
|
|
|
| Secondary | Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Over Time | 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. | Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Weeks 8, 16, and 24 |
|
|
|
| Secondary | Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 24 | Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used. | Posted | Least Squares Mean | Standard Error | mg/L | Baseline and week 24 |
|
|
|
| 0 |
| 46 |
| 1 |
| 46 |
| 27 |
| 46 |
| Generalised tonic-clonic seizure | Nervous system disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Chest pain | General disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Cyst | General disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Beta haemolytic streptococcal infection | Infections and infestations | MEDDRA 19.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MEDDRA 19.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MEDDRA 19.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MEDDRA 19.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MEDDRA 19.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MEDDRA 19.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MEDDRA 19.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MEDDRA 19.1 | Systematic Assessment |
|
| Streptococcal bacteraemia | Infections and infestations | MEDDRA 19.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MEDDRA 19.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MEDDRA 19.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MEDDRA 19.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MEDDRA 19.1 | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MEDDRA 19.1 | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MEDDRA 19.1 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MEDDRA 19.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MEDDRA 19.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MEDDRA 19.1 | Systematic Assessment |
|
| Liver function test increased | Investigations | MEDDRA 19.1 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MEDDRA 19.1 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Polymyalgia rheumatica | Metabolism and nutrition disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Mood altered | Psychiatric disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Crystalluria | Renal and urinary disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Vulvovaginal dryness | Reproductive system and breast disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Peripheral venous disease | Vascular disorders | MEDDRA 19.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MEDDRA 19.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
|
| Week 24 |
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| Week 24 |
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| Moderately dissatisfied |
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| Completely dissatisfied |
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| Missing |
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| Week 8 |
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| Week 16 |
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| Week 24 |
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| Moderately dissatisfied |
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| Completely dissatisfied |
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| Missing |
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| Week 8 |
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| Week 16 |
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| Week 24 |
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| Week 24 |
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| Week 24 |
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