MAP Study: Methotrexate and Adalimumab in Psoriasis

NCT03217734 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: A16-241
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 4

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• PASI Change

  Mean percent change in PASI from 16 Weeks to Baseline

  16 weeks

Secondary Outcomes (1)

• ADA/Anti ADA Antibodies

  16 weeks

Study Arms (2)

ADA and Placebo

PLACEBO COMPARATOR

Adalimumab 40 mg, Subcutaneous, Bi-Weekly, 16 Weeks Placebo, Tablet, Oral, Weekly, 16 Weeks

Biological: Adalimumab; Drug: Placebo

ADA and MTX

ACTIVE COMPARATOR

Adalimumab 40 mg, Subcutaneous, Bi-Weekly, 16 Weeks Methotrexate, 2.5 mg Tablet, 10 mg Weekly, Oral, 16 Weeks

Biological: Adalimumab; Drug: Methotrexate

Interventions

Adalimumab BIOLOGICAL

Subcutaneous Injection

Also known as: Humira

ADA and MTX; ADA and Placebo

Methotrexate DRUG

Oral Tablet

Also known as: MTX

ADA and MTX

Placebo DRUG

Oral Tablet

ADA and Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Condoms, sponge, foams, jellies, diaphragm, or intrauterine device (IUD)
• Hormonal contraceptives for 90 days prior to study drug administration
• A vasectomized partner
• 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.

You may not qualify if:

• Diagnosis or presence of guttate, erythrodermic or pustular psoriasis
• Any previous exposure to ADA including biosimilar ADA
• Moderate to high strength topical steroids (class 4 or greater) or Vitamin D analogues within one week of study entry
• Oral systemic therapy (methotrexate, cyclosporine, apremilast, acitretin) within 8 weeks of study entry
• Previous intolerance or adverse reaction to MTX
• Phototherapy of any type within 4 weeks of study entry (narrowband UVB, psoralen-UVA, 308 nM LASER, commercial tanning units)
• IL-12/23 inhibitors (ustekinumab) and any IL-23 inhibitor (guselkumab, tildrakizumab, risankizumab) within 12 weeks of baseline
• Other biologic agents within 8 weeks of study entry
• History of chronic liver disease, hepatitis, or alcohol abuse
• Chronic use of any concomitant medication which has a significant potential for interaction with MTX (e.g. sulfa antibiotics, chronic non-steroidal anti-inflammatory (NSAID) use)
• History of tuberculosis, opportunistic infections, or any active infection at screening
• Elevated liver enzymes (AST, ALT, ≥1.5 times normal at screening)
• Serum creatinine ≥1.5 (at screening)
• Any other laboratory abnormality that would pose a concern for the investigator
• Daily alcohol use or consumption of more than four alcoholic drinks (4 ounces) in one 24 hour period

Sponsors & Collaborators

• Jeffrey J Crowley MD: lead
• AbbVie: collaborator

Study Sites (4)

Bakersfield Dermatology and Skin Cancer Medical Group

Bakersfield, California, 93309, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

DermAssociates, PC

Rockville, Maryland, 20850, United States

Location

Modern Research Associates, PLLC

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab; Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jeffrey J Crowley, MD

  Bakersfield Dermatology and Skin Cancer Medical Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Jeffrey J Crowley, MD, Prinicipal Investigator

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 14, 2017
• Study Start: April 10, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)