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infliximab therapeutic drug monitoring
infliximab therapeutic drug monitoring is a TNF-α inhibitor (monoclonal antibody) Biologic drug developed by Imelda GI Clinical Research Center. It is currently FDA-approved for Crohn's disease, Ulcerative colitis, Rheumatoid arthritis.
Infliximab is a chimeric monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), a key inflammatory cytokine.
Infliximab is a chimeric monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), a key inflammatory cytokine. Used for Crohn's disease, Ulcerative colitis, Rheumatoid arthritis.
At a glance
| Generic name | infliximab therapeutic drug monitoring |
|---|---|
| Sponsor | Imelda GI Clinical Research Center |
| Drug class | TNF-α inhibitor (monoclonal antibody) |
| Target | TNF-α (tumor necrosis factor-alpha) |
| Modality | Biologic |
| Therapeutic area | Immunology / Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Infliximab blocks TNF-α signaling by binding directly to soluble and membrane-bound TNF-α, preventing its interaction with TNF receptors on immune cells and reducing inflammatory responses. This therapeutic drug monitoring service measures infliximab serum concentrations and anti-drug antibodies to optimize dosing and predict treatment response or loss of efficacy in patients with inflammatory bowel disease and other TNF-α-mediated conditions.
Approved indications
- Crohn's disease
- Ulcerative colitis
- Rheumatoid arthritis
- Ankylosing spondylitis
- Psoriasis
- Psoriatic arthritis
Common side effects
- Infections (including tuberculosis, fungal, and opportunistic)
- Infusion reactions
- Headache
- Abdominal pain
- Nausea
- Antibody formation (anti-infliximab antibodies)
Key clinical trials
- MICI-BIO: Study on Patient With Chronic Inflammatory Bowel Disease (NA)
- Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (PHASE4)
- Infliximab Efficacy, TDM and Serum TNFα Levels in Pediatric HSCT Recipients With aGVHD: Prospective Observational Study
- Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis
- Therapeutic Drug Monitoring for Biological Therapy in Pediatric Inflammatory Bowel Disease
- PROactive and Early Infliximab Monitoring and OPTimization in Inflammatory Bowel Disease (NA)
- TDM-based Infliximab Treatment for Active Perianal Fistulizing Crohn's Disease (PHASE4)
- Stavanger IBD Study - Cross Sectional
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:
- infliximab therapeutic drug monitoring CI brief — competitive landscape report
- infliximab therapeutic drug monitoring updates RSS · CI watch RSS
- Imelda GI Clinical Research Center portfolio CI
Frequently asked questions about infliximab therapeutic drug monitoring
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Related
- Drug class: All TNF-α inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting TNF-α (tumor necrosis factor-alpha)
- Manufacturer: Imelda GI Clinical Research Center — full pipeline
- Therapeutic area: All drugs in Immunology / Gastroenterology
- Indication: Drugs for Crohn's disease
- Indication: Drugs for Ulcerative colitis
- Indication: Drugs for Rheumatoid arthritis
- Compare: infliximab therapeutic drug monitoring vs similar drugs
- Pricing: infliximab therapeutic drug monitoring cost, discount & access