MAP Study: Methotrexate and Adalimumab in Psoriasis

Part of paid clinical trials in Bakersfield, California.

Sponsor
Jeffrey J Crowley MD
Study ID
NCT03217734
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Adalimumab — BIOLOGICAL
    Subcutaneous Injection
  • Methotrexate — DRUG
    Oral Tablet
  • Placebo — DRUG
    Oral Tablet

Study Details

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.

Key Dates

Start date
Apr 10, 2017
Status verified
Jul 2019
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: ADA and Placebo
    Adalimumab 40 mg, Subcutaneous, Bi-Weekly, 16 Weeks Placebo, Tablet, Oral, Weekly, 16 Weeks
  • Active Comparator: ADA and MTX
    Adalimumab 40 mg, Subcutaneous, Bi-Weekly, 16 Weeks Methotrexate, 2.5 mg Tablet, 10 mg Weekly, Oral, 16 Weeks

Primary Outcome Measure

PASI Change [ Time Frame: 16 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
Bakersfield Dermatology and Skin Cancer Medical GroupBakersfieldCalifornia93309-
Clinical Science InstituteSanta MonicaCalifornia90404-
DermAssociates, PCRockvilleMaryland20850-
Modern Research Associates, PLLCDallasTexas75231-

Find similar trials in Bakersfield, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Bakersfield Dermatology and Skin Cancer Medical Group· Bakersfield, CAClinical Science Institute· Santa Monica, CADermAssociates, PC· Rockville, MDModern Research Associates, PLLC· Dallas, TX

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