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Adalimumab

Clinical trials investigating Adalimumab are studying how well it works and how safe it is in different patient groups. These studies include people with bowel disease, arthritis, uveitis, and other inflammatory conditions. They also look at treatment strategies such as starting, switching, tapering, or stopping therapy.

Table of Contents

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]

Trial ID Phase Condition studied Status Enrollment
2023-509733-39-00Phase 3Noninfectious uveitisAuthorised320
NCT03917303Phase 3Crohn’s diseaseAuthorised158
2022-502578-18-00Low InterventionRheumatoid arthritisAuthorised463
NCT02629159Phase 3Rheumatoid arthritisAuthorised1521
2024-513299-17-00Phase 3Ulcerative colitis, Crohn’s diseaseAuthorised350
2024-513017-12-00Phase 3Juvenile Idiopathic ArthritisAuthorised150
2024-516277-68-00Phase 3Crohn’s disease, Ulcerative colitisAuthorised148
2024-514633-38-00Phase 3Crohn’s DiseaseAuthorised166
2023-505112-38-00Low InterventionRecently active non-infectious intermediate, posterior, and pan-uveitisAuthorised120
2024-514313-35-00Phase 3Arthritis rheumatoidAuthorised60
NCT05313620Phase 3Ulcerative colitisAuthorised60
2024-515557-22-00Phase 3Juvenile Idiopathic ArthritisAuthorised290
2023-503701-11-00Phase 3Dupuytren DiseaseCompleted30
NCT02632175Phase 3Ulcerative ColitisCompleted59
NCT06117423Phase 1/2Inflammatory Bowel Disease (IBD)Completed18

FAQ

  • What kinds of conditions are being studied with Adalimumab? The trials cover several conditions, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, juvenile idiopathic arthritis, uveitis, psoriatic arthritis, hidradenitis suppurativa, Takayasu arteritis, Behçet’s uveitis, Dupuytren disease, and axial spondyloarthritis.
  • Who can take part in Adalimumab trials? It depends on the study. Some trials include adults only, some include children and teenagers, and some focus on people with active disease, stable remission, or disease that did not respond well to earlier treatment.
  • What phases are the Adalimumab trials in? Most studies are Phase 2 or Phase 3, with a few low-intervention studies and one Phase 1/2 study. This means the trials are often testing effectiveness, safety, or the best way to use treatment in real patient groups.
  • What are the trials trying to measure? Common study goals include remission, flare prevention, endoscopic healing, eye inflammation control, joint disease activity, and safety. Some trials also measure biomarker results, imaging findings, or drug monitoring results.
  • Are all studies testing Adalimumab alone? No. Some trials compare Adalimumab with other medicines, placebo, or standard care. Others study tapering, stopping, switching, or using Adalimumab as part of a treatment strategy.

Ongoing Clinical Trials on Adalimumab

  • Study on the Safety and Imaging of Adalimumab-680LT for Patients with Inflammatory Bowel Disease

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study Comparing Upadacitinib, Placebo, and Adalimumab for Patients with Moderate to Severe Rheumatoid Arthritis on Stable Methotrexate Treatment

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Bulgaria Croatia Czechia Estonia France +11

  • Study on the Effects of Adalimumab and Saline in Patients Undergoing Needle Fasciotomy for Dupuytren’s Disease

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

Glossary

  • Phase 1/2: An early stage study that looks at safety and also begins to test whether the treatment may help.
  • Phase 2: A study stage that mainly checks whether the treatment seems to work and whether it is safe enough to study further.
  • Phase 3: A larger study that compares treatments in more patients and often looks at how well a treatment works in real use.
  • Interventional study: A trial where researchers give a treatment or compare treatments and then measure the results.
  • Remission: A period when signs of disease are very low or absent.
  • Endoscopic remission: Healing seen during an endoscopy, which is a test using a small camera to look inside the body, often the bowel.
  • Biomarker: A measurable sign in the body, such as a lab result, that can show disease activity or response to treatment.
  • Flare: A return or worsening of disease symptoms after a period of better control.
  • Treatment failure: When the study-defined goals are not reached, such as worsening symptoms or needing extra treatment.
  • Therapeutic drug monitoring: Checking medicine levels in the body to help guide treatment decisions.
  • JADAS: Juvenile Arthritis Disease Activity Score, a score used to measure how active arthritis is in children.
  • DAS28-CRP: A score used to measure rheumatoid arthritis activity using joint findings and a blood test called CRP.

References