Psoriasis Clinical Trial
Official title:
MAP Study (Methotrexate and Adalimumab in Psoriasis): Adalimumab vs. Combination Adalimumab and Methotrexate in Psoriasis: Efficacy and Anti-Adalimumab Antibody Formation
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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