Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-08 @ 3:43 AM
Study NCT ID:
NCT03217734
Status:
COMPLETED
Last Update Posted:
2019-07-09
First Post:
2017-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MAP Study: Methotrexate and Adalimumab in Psoriasis
Sponsor:
Jeffrey J Crowley MD
Organization:
Study Overview
Official Title:
MAP Study (Methotrexate and Adalimumab in Psoriasis): Adalimumab vs. Combination Adalimumab and Methotrexate in Psoriasis: Efficacy and Anti-Adalimumab Antibody Formation
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAP
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: