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Placebo + Methotrexate (MTX)
Methotrexate inhibits dihydrofolate reductase to suppress DNA synthesis and reduce inflammatory immune cell proliferation.
Methotrexate inhibits dihydrofolate reductase to suppress DNA synthesis and reduce inflammatory immune cell proliferation. Used for Rheumatoid arthritis, Other autoimmune/inflammatory conditions (specific indication dependent on trial protocol).
At a glance
| Generic name | Placebo + Methotrexate (MTX) |
|---|---|
| Also known as | MTX |
| Sponsor | UCB Pharma |
| Drug class | Antimetabolite / Disease-modifying antirheumatic drug (DMARD) |
| Target | Dihydrofolate reductase (DHFR) |
| Modality | Biologic |
| Therapeutic area | Immunology / Rheumatology |
| Phase | Phase 3 |
Mechanism of action
Methotrexate is a folate antagonist that blocks dihydrofolate reductase, thereby inhibiting nucleotide synthesis and cell division. In rheumatologic and autoimmune conditions, it suppresses T-cell and B-cell proliferation and reduces production of pro-inflammatory cytokines. The placebo control in this phase 3 trial serves as a comparator to assess MTX efficacy.
Approved indications
- Rheumatoid arthritis
- Other autoimmune/inflammatory conditions (specific indication dependent on trial protocol)
Common side effects
- Nausea and gastrointestinal upset
- Myelosuppression (anemia, leukopenia, thrombocytopenia)
- Hepatotoxicity
- Mouth ulcers / stomatitis
- Alopecia
- Infection risk
Key clinical trials
- A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE) (PHASE2)
- A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014) (PHASE2)
- A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis (PHASE1)
- Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis (PHASE3)
- Efficacy and Safety Study of MP-435 in Combination With Methotrexate (MTX) in Patients With Rheumatoid Arthritis (PHASE2)
- Methotrexate Treatment of Arthritis Caused by Chikungunya Virus (MARCH) (PHASE3)
- Natrunix in Combination With Methotrexate for Rheumatoid Arthritis Treatment (PHASE2)
- Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases (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:
- Placebo + Methotrexate (MTX) CI brief — competitive landscape report
- Placebo + Methotrexate (MTX) updates RSS · CI watch RSS
- UCB Pharma portfolio CI