Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Necrosis

Psoriasis

Skin Diseases

Skin Diseases, Papulosquamous

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Micronutrients

Hematinics

Vitamins

Methotrexate

Adalimumab

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Tumor Necrosis Factor Inhibitors

Folinic Acid

Folate

Vitamin B9

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.

Administered by subcutaneous injection every other week.

Methotrexate was provided as 2.5 mg tablets for oral administration.

Marc-André Raymond, PhD

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.

Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study

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:

* Completely dissatisfied
* Moderately dissatisfied
* Slightly satisfied
* Highly satisfied
* Completely satisfied

Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

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:

* Completely dissatisfied
* Moderately dissatisfied
* Slightly satisfied
* Highly satisfied
* Completely satisfied

Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

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:

* Completely dissatisfied
* Moderately dissatisfied
* Slightly satisfied
* Highly satisfied
* Completely satisfied

Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

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:

* Completely dissatisfied
* Moderately dissatisfied
* Slightly satisfied
* Highly satisfied
* Completely satisfied

Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

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:

* Completely dissatisfied
* Moderately dissatisfied
* Slightly satisfied
* Highly satisfied
* Completely satisfied

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:

* Completely dissatisfied
* Moderately dissatisfied
* Slightly satisfied
* Highly satisfied
* Completely satisfied

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.

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.

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.

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.

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).

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:

* 0 (Cleared): No evidence of scaling, erythema, or plaque elevation;
* 1 (Minimal): Occasional fine scale over \<5% of lesions, faint erythema, minimal plaque elevation;
* 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation;
* 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation;
* 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation;
* 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.

The percentage of participants achieving a score of clear (0) or minimal (1) is reported.

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.

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.

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.

AbbVie

Adalimumab + Methotrexate

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.

Primary 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.

Secondary Sub-optimal Responders - ADA + MTX

Total

Age, Continuous

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race/Ethnicity, Customized

Duration of Psoriasis

Global Medical Services

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.

Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment

Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Patient Self-assessment

Baseline

Week 8

Week 24

Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.

Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time

Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time

Week 16

Participants who received at least one dose of ADA and one dose of MTX with available data at each time point.

Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time

Participants who received at least one dose of ADA and one dose of MTX and with available data at each time point..

Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time

Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time

Percentage of Participants Who Achieved a PASI 75 Response Over Time

Percentage of Participants Who Achieved a PASI 90 Response Over Time

Percentage of Participants Who Achieved a PASI 100 Response Over Time

Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.

Spots Global Cancer Trial Database for Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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