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Double-Blind Adalimumab/Placebo + MTX
Double-Blind Adalimumab/Placebo + MTX is a TNF-alpha inhibitor (monoclonal antibody) Biologic drug developed by Abbott. It is currently in Phase 3 development for Rheumatoid arthritis (in combination with methotrexate), Polyarticular juvenile idiopathic arthritis, Ankylosing spondylitis. Also known as: ABT-D2E7, Humira.
Adalimumab is a TNF-alpha inhibitor that blocks tumor necrosis factor-alpha signaling to reduce inflammation, combined with methotrexate for enhanced immunosuppressive effect.
Adalimumab is a TNF-alpha inhibitor that blocks tumor necrosis factor-alpha signaling to reduce inflammation, combined with methotrexate for enhanced immunosuppressive effect. Used for Rheumatoid arthritis (in combination with methotrexate), Polyarticular juvenile idiopathic arthritis, Ankylosing spondylitis.
At a glance
| Generic name | Double-Blind Adalimumab/Placebo + MTX |
|---|---|
| Also known as | ABT-D2E7, Humira |
| Sponsor | Abbott |
| Drug class | TNF-alpha inhibitor (monoclonal antibody) |
| Target | TNF-alpha |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Adalimumab is a fully human monoclonal antibody that binds to and neutralizes TNF-alpha, a key pro-inflammatory cytokine. When combined with methotrexate (MTX), a disease-modifying antirheumatic drug (DMARD), the dual mechanism provides synergistic suppression of inflammatory pathways in autoimmune conditions. This combination is standard-of-care for rheumatoid arthritis and other TNF-driven inflammatory diseases.
Approved indications
- Rheumatoid arthritis (in combination with methotrexate)
- Polyarticular juvenile idiopathic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Psoriasis
- Psoriatic arthritis
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Nausea
- Serious infections (tuberculosis, opportunistic)
- Malignancy risk
Key clinical trials
- 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)
- 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)
- A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (PHASE3)
- Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (PHASE3)
- Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) (PHASE2)
- ADalimumab in Persistent Early Oligoarthrits Study (ADEOS) (PHASE2)
- A Study in Moderate to Severe Rheumatoid Arthritis (PHASE3)
- A Double Blind Study in Pediatric Subjects With Chronic Plaque Psoriasis, Studying Adalimumab vs. Methotrexate (PHASE3)
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:
- Double-Blind Adalimumab/Placebo + MTX CI brief — competitive landscape report
- Double-Blind Adalimumab/Placebo + MTX updates RSS · CI watch RSS
- Abbott portfolio CI
Frequently asked questions about Double-Blind Adalimumab/Placebo + MTX
What is Double-Blind Adalimumab/Placebo + MTX?
How does Double-Blind Adalimumab/Placebo + MTX work?
What is Double-Blind Adalimumab/Placebo + MTX used for?
Who makes Double-Blind Adalimumab/Placebo + MTX?
Is Double-Blind Adalimumab/Placebo + MTX also known as anything else?
What drug class is Double-Blind Adalimumab/Placebo + MTX in?
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What are the side effects of Double-Blind Adalimumab/Placebo + MTX?
What does Double-Blind Adalimumab/Placebo + MTX target?
Related
- Drug class: All TNF-alpha inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting TNF-alpha
- Manufacturer: Abbott — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis (in combination with methotrexate)
- Indication: Drugs for Polyarticular juvenile idiopathic arthritis
- Indication: Drugs for Ankylosing spondylitis
- Also known as: ABT-D2E7, Humira
- Compare: Double-Blind Adalimumab/Placebo + MTX vs similar drugs
- Pricing: Double-Blind Adalimumab/Placebo + MTX cost, discount & access