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Anti-metabolites

Methotrexate Injections for Psoriasis

Phase 4
Waitlist Available
Led By Shari Lipner, MD, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be at least 18 years of age
Subject must have nail psoriasis that is clinically diagnosed in at least 3 fingernails
Must not have
Subject who is on systemic treatment for psoriasis
Subjects with diagnosis of renal insufficiency or impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

"This trial aims to find out if methotrexate injections are effective in treating nail psoriasis."

Who is the study for?
This trial is for individuals with nail psoriasis. Specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed requirements on who can participate.
What is being tested?
The trial aims to test the effectiveness of methotrexate injections compared to saline (a placebo) and triamcinolone acetonide (a steroid) in treating nail psoriasis.
What are the potential side effects?
Potential side effects may include local reactions at the injection site, such as pain or swelling. Methotrexate can also cause systemic effects like fatigue, nausea, and liver issues; steroids may lead to skin thinning or increased blood sugar.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have been diagnosed with nail psoriasis in at least 3 of my fingernails.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently on medication for psoriasis.
Select...
I have been diagnosed with kidney problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), during intervention (weeks 1, 7, 13), post-intervention (weeks 17, 37) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline of nail dystrophy as measured by the Nail Psoriasis Severity Index
Change from baseline of nail dystrophy as measured by the Physician-Assessed Global Improvement
Secondary study objectives
Treatment-Related Adverse Events

Side effects data

From 2015 Phase 3 trial • 139 Patients • NCT02001987
11%
Rheumatoid arthritis
11%
Rhinitis
9%
Asthenia
9%
Bronchitis
8%
Nasopharyngitis
8%
Alanine aminotransferase increased
8%
Arthralgia
8%
Headache
7%
Neutropenia
6%
Diarrhoea
5%
Back pain
5%
Hepatocellular injury
5%
Transaminases increased
5%
Insomnia
5%
Abdominal pain
4%
Urinary tract infection
3%
Ear infection
3%
Injection site erythema
3%
Pruritus
2%
Nausea
2%
Hypertension
1%
Gastric volvulus
1%
Angioedema
1%
Gastric ulcer
1%
Intestinal ischaemia
1%
Pulmonary embolism
1%
Deep vein thrombosis
1%
Hypertensive crisis
1%
Iron deficiency anaemia
1%
Cataract
1%
Cervical dysplasia
1%
Disseminated tuberculosis
1%
Septic shock
1%
Meningitis tuberculous
1%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCZ COMBO - All Participants
TCZ MONO - All Participants
TCZ - All Participants

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Intralesional MethotrexateExperimental Treatment1 Intervention
Participants receive intralesional methotrexate injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
Group II: Intralesional Triamcinolone AcetonideActive Control1 Intervention
Participants receive intralesional triamcinolone acetonide injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
Group III: Intralesional Placebo (saline)Placebo Group1 Intervention
Participants receive intralesional saline injections into 1 nail bed/nail matrix every 6 weeks for 3 sessions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate
2019
Completed Phase 4
~4400

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,155,353 Total Patients Enrolled
3 Trials studying Psoriasis
81 Patients Enrolled for Psoriasis
Shari Lipner, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University
4 Previous Clinical Trials
93 Total Patients Enrolled
1 Trials studying Psoriasis
11 Patients Enrolled for Psoriasis
~7 spots leftby Jan 2026
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