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Methotrexate + Infliximab
Methotrexate suppresses immune cell proliferation while infliximab blocks tumor necrosis factor-alpha, together reducing inflammatory and autoimmune responses.
Methotrexate suppresses immune cell proliferation while infliximab blocks tumor necrosis factor-alpha (TNF-α), together reducing inflammatory and autoimmune responses. Used for Rheumatoid arthritis, Crohn's disease, Ulcerative colitis.
At a glance
| Generic name | Methotrexate + Infliximab |
|---|---|
| Sponsor | Université Catholique de Louvain |
| Drug class | Combination therapy: antimetabolite + TNF-α inhibitor |
| Target | Dihydrofolate reductase (methotrexate); TNF-α (infliximab) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rheumatology |
| Phase | FDA-approved |
Mechanism of action
Methotrexate is an antimetabolite that inhibits dihydrofolate reductase, reducing DNA synthesis and suppressing T-cell and B-cell proliferation. Infliximab is a chimeric monoclonal antibody that binds TNF-α, a key pro-inflammatory cytokine, preventing its interaction with TNF receptors. The combination provides synergistic immunosuppression and anti-inflammatory effects, particularly effective in TNF-driven autoimmune diseases.
Approved indications
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Ankylosing spondylitis
- Psoriatic arthritis
Common side effects
- Infection (including serious infections)
- Nausea and gastrointestinal disturbance
- Hepatotoxicity
- Bone marrow suppression
- Infusion reactions
- Headache
Key clinical trials
- Combined Immunosuppression for Pediatric Crohn's Disease (PHASE4)
- An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis (PHASE2)
- Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis (PHASE3)
- Determination of the Optimal Treatment Target in Ulcerative Colitis (PHASE4)
- Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (PHASE4)
- Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Rheumatoid Arthritis)
- Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease (NA)
- Multicenter Randomized Double Blind Controlled-study to Assess the Potential of Methotrexate Versus Placebo to Improve and Maintain Response to Anti TNF- Alpha Agents in Adult Patients With Moderate to Severe Psoriasis (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Methotrexate + Infliximab CI brief — competitive landscape report
- Methotrexate + Infliximab updates RSS · CI watch RSS
- Université Catholique de Louvain portfolio CI