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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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Assess the efficacy and safety of ADA compared to ADA/MTX in patient with Psoriasis. Compare Anti-ADA antibody formation and serum ADA levels in patients on ADA compared with those on combination ADA and MTX.
Assess the efficacy and safety of ADA compared to ADA/MTX in patients with psoriasis. Many studies of ADA in rheumatoid and psoriatic arthritis have allowed patients on stable doses of MTX to continue on MTX while being treated with ADA. There has been no prospective trial of MTX and ADA concomitantly in psoriasis. Safety of ADA monotherapy vs. combination ADA/MTX will be compared.
Compare anti-ADA antibody formation and serum ADA levels in patients on ADA compared with those on combination ADA and MTX. ADA is a fully human monoclonal antibody to TNF-a. More recent advances in detection of ADA antibodies have shown that many patients develop antibodies to ADA while on treatment and some of these antibodies are neutralizing. The presence of anti-ADA antibodies has been correlated with loss of therapeutic response in many disease states.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADA and Placebo | Placebo Comparator | Adalimumab 40 mg, Subcutaneous, Bi-Weekly, 16 Weeks Placebo, Tablet, Oral, Weekly, 16 Weeks |
|
| ADA and MTX | Active Comparator | Adalimumab 40 mg, Subcutaneous, Bi-Weekly, 16 Weeks Methotrexate, 2.5 mg Tablet, 10 mg Weekly, Oral, 16 Weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological | Subcutaneous Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| PASI Change | Mean percent change in PASI from 16 Weeks to Baseline | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ADA/Anti ADA Antibodies | Antibodies to Adalimumab at 16 weeks | 16 weeks |
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Inclusion Criteria:
Male or female adult (≥ 18yrs) with a diagnosis of moderate to severe plaque psoriasis
Subject must have ≥ 10% body surface area involvement
Subject must have psoriasis area and severity index (PASI) ≥12
Subject has stable psoriasis of at least six months' duration
Male subjects must agree to use a reliable form of birth control during the study and for 180 days after the last dose of study drug. Male subjects must not donate sperm during the study or for 180 days after the last dose of study drug. If female, subject is either not of childbearing potential (postmenopausal for at least 1 year or surgically sterile) or is of childbearing potential and is using approved method of birth control throughout study and for 180 days after last dose of study drug. Approved methods of birth control include the following:
Subject has negative PPD tuberculosis skin test at screening assessment.
Subject must be able and willing to provide written informed consent and comply with requirements of this study protocol.
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey J Crowley, MD | Bakersfield Dermatology and Skin Cancer Medical Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakersfield Dermatology and Skin Cancer Medical Group | Bakersfield | California | 93309 | United States | ||
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| 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 | Oral Tablet |
|
|
| Placebo | Drug | Oral Tablet |
|
| Clinical Science Institute |
| Santa Monica |
| California |
| 90404 |
| United States |
| DermAssociates, PC | Rockville | Maryland | 20850 | United States |
| Modern Research Associates, PLLC | Dallas | Texas | 75231 | United States |
| 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 |