PsoriasisPhase 2/3MAPNCT03217734
MAP Study: Methotrexate and Adalimumab in Psoriasis
A Phase 2/3 study testing Adalimumab and Methotrexate in people with Psoriasis, run by Jeffrey J Crowley MD at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Adalimumab and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Apr 2017to 31 Dec 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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)
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- 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
- Patients who test positive for hepatitis B or C exposure (previous vaccination to Hepatitis B is allowed)
- Cancer within the last five years is exclusionary with the exception of treated cutaneous basal cell carcinoma or squamous cell carcinoma or low-grade cervical intraepithelial neoplasia.
- Any patient that is deemed by the investigator to be at a safety risk for the intervention in this trial.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, 93309
Modern Research Associates, PLLC
Dallas, Texas, 75231
DermAssociates, PC
Rockville, Maryland, 20850
Clinical Science Institute
Santa Monica, California, 90404
About this study
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Adalimumab, Methotrexate, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabBiological
Also called Humira
Subcutaneous Injection
MethotrexateDrug
Also called MTX
Oral Tablet
PlaceboDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| ADA and Placebo | Placebo comparator | Adalimumab 40 mg, Subcutaneous, Bi-Weekly, 16 Weeks Placebo, Tablet, Oral, Weekly, 16 Weeks Receives: 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 Receives: Biological: Adalimumab; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI Change
Mean percent change in PASI from 16 Weeks to Baseline
Measured: 16 weeks
Secondary outcomes (1)
ADA/Anti ADA Antibodies
Antibodies to Adalimumab at 16 weeks
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start10 Apr 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey J Crowley MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Responsible party
- Sponsor-investigator, Jeffrey J Crowley MD, Bakersfield Dermatology & Skin Cancer Medical Group
- Investigators
- Jeffrey J Crowley, MD, Study director, Bakersfield Dermatology and Skin Cancer Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217734
- Sponsor's protocol ID
- A16-241
- Acronym
- MAP
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2017
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAP Study (Methotrexate and Adalimumab in Psoriasis): Adalimumab vs. Combination Adalimumab and Methotrexate in Psoriasis: Efficacy and Anti-Adalimumab Antibody Formation
- ClinicalTrials.gov ID
- NCT03217734
- Acronym / sponsor ID
- MAP / A16-241
- Conditions
- Psoriasis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Jeffrey J Crowley MDIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADA and Placebo | Placebo comparator | Biological: Adalimumab, Drug: PlaceboAdalimumab 40 mg, Subcutaneous, Bi-Weekly, 16 Weeks Placebo, Tablet, Oral, Weekly, 16 Weeks |
| ADA and MTX | Active comparator | Biological: Adalimumab, Drug: MethotrexateAdalimumab 40 mg, Subcutaneous, Bi-Weekly, 16 Weeks Methotrexate, 2.5 mg Tablet, 10 mg Weekly, Oral, 16 Weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: HumiraSubcutaneous Injection | Biological | ADA and MTX, ADA and Placebo |
| MethotrexateAlso: MTXOral Tablet | Drug | ADA and MTX |
| PlaceboOral Tablet | Drug | ADA and Placebo |
Primary outcome
PASI Change
Time frame: 16 weeks
Mean percent change in PASI from 16 Weeks to Baseline
1 secondary outcome
ADA/Anti ADA Antibodies
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J Crowley, MD study director
Bakersfield Dermatology and Skin Cancer Medical Group
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adalimumab and Methotrexate in people with Psoriasis, run by Jeffrey J Crowley MD at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PASI Change (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.