Table of Contents
- Clinical trial overview
- Conditions being studied
- Trial designs and comparison groups
- Main endpoints and what they mean
- Who can take part
- Key trials in this set
- What these studies aim to learn
Clinical trial overview
These studies investigate Adalimumab in many different patient groups and diseases, mainly inflammatory conditions. Most trials are designed to test whether treatment helps control disease, prevents worsening, or supports long-term disease control.[1]
The trial set includes both interventional studies, where patients receive a study treatment, and some low-intervention studies, where treatment is part of a structured care plan.[1] The phases range from Phase 1/2 to Phase 3, which shows that the research includes early feasibility work as well as larger confirmatory studies.[1]
Conditions being studied
Many trials focus on inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.[1] Several studies also focus on rheumatoid arthritis and juvenile idiopathic arthritis, including children and teenagers with active disease or disease in remission.[1]
Eye inflammation is another major area, especially noninfectious uveitis, including intermediate, posterior, pan-uveitis, JIA-associated uveitis, chronic anterior uveitis, and Behçet’s disease uveitis.[1] Other conditions include psoriatic arthritis, hidradenitis suppurativa, Takayasu arteritis, Dupuytren disease, axial spondyloarthritis, and a small number of complex inflammatory diseases.[1]
Trial designs and comparison groups
Some studies compare Adalimumab with another active medicine, such as mycophenolate mofetil, abatacept, vedolizumab, baricitinib, infliximab, or tocilizumab, depending on the condition.[1] Other trials compare Adalimumab with placebo or with standard care to see whether a new strategy works better.[1]
Several trials study treatment strategies rather than only the drug itself. These include starting biologic treatment early, changing to another drug after loss of response, tapering treatment, stopping treatment in remission, or using therapeutic drug monitoring to guide dosing decisions.[1]
Main endpoints and what they mean
Many trials measure remission, which means the disease is very quiet or inactive.[1] In bowel disease trials, common endpoints include endoscopic remission, deep remission, clinical remission, and corticosteroid-free remission, which means patients are doing well without needing steroid medicine.[1]
In arthritis trials, important endpoints include ACR20, ACR50, DAS28-CRP, JADAS, cJADAS10, and minimal disease activity. These are scoring systems that show how active the disease is and whether joints are improving.[1]
In eye trials, endpoints include treatment failure, complete ophthalmological response, good clinical response, and response based on SUN criteria. These terms describe changes in eye inflammation, vision, and the need for extra treatment.[1]
Safety is also measured in many studies, often through adverse events, serious adverse events, lab tests, vital signs, ECGs, or infection monitoring.[1]
Who can take part
Eligibility depends on the specific trial. Some studies include adults with active disease, while others focus on children and adolescents, such as those with juvenile idiopathic arthritis or pediatric ulcerative colitis.[1]
Many trials require a certain disease state, such as active disease, steroid dependence, remission, loss of response to earlier treatment, or risk of relapse after surgery or treatment withdrawal.[1] Some studies also use special markers, imaging results, or therapeutic drug levels to choose participants or guide treatment decisions.[1]
Key trials in this set
2023-509733-39-00 studies whether spacing Adalimumab based on therapeutic drug monitoring can keep complete eye response and avoid infection in noninfectious uveitis over 48 weeks.[1]
NCT03917303 compares long-term periodic Adalimumab as initial treatment with standard step-up care in newly diagnosed Crohn’s disease, with the main outcome being corticosteroid-free clinical and biochemical remission at week 96.[1]
NCT02629159 compares Upadacitinib with placebo and Adalimumab in rheumatoid arthritis and measures ACR20 response or clinical remission at week 12.[1]
NCT04183608 studies a treat-to-target follow-up with e-monitoring and home fecal calprotectin testing for patients with ulcerative colitis who are starting Adalimumab, with endoscopic remission at week 48 as the main success measure.[1]
2024-513299-17-00 looks at stopping anti-TNF treatment, including Humira, in patients with Crohn’s disease or ulcerative colitis who are in remission, and checks relapse at 12 and 24 months.[1]
2024-513017-12-00 studies treatment withdrawal strategies in juvenile idiopathic arthritis and measures disease flares during the first 12 months.[1]
2024-514633-38-00 compares azathioprine and methotrexate when used with Adalimumab in Crohn’s disease, using endoscopic response at week 26 as the main outcome.[1]
2024-514313-35-00 estimates the Adalimumab trough concentration, which means the amount of drug left in the blood before the next dose, that may help maintain remission in rheumatoid arthritis.[1]
What these studies aim to learn
Overall, the trial program is trying to learn when Adalimumab works best, how to measure response, and how to use it more safely and effectively in different diseases.[1] The studies also explore whether early treatment, dose spacing, stopping treatment, switching medicines, or guided monitoring can improve patient outcomes.[1]
Because the trials include many disease areas and ages, the evidence is meant to help guide treatment choices for both adults and children with inflammatory disease.[1]
