Simponi (golimumab)

P2, N=35, Not yet recruiting, Sun Yat-sen University

P=N/A, N=4000, Not yet recruiting, Pfizer | Trial completion date: Oct 2025 --> Mar 2026 | Initiation date: Sep 2025 --> Dec 2025 | Trial primary completion date: Oct 2025 --> Mar 2026

P3, N=63, Recruiting, University of Pennsylvania | N=150 --> 63 | Trial completion date: May 2026 --> Oct 2026 | Trial primary completion date: May 2026 --> Oct 2026

Tumor necrosis alpha (TNF-alpha) inhibitors are a group of biologics approved for treatment of AS (e.g. adalimumab, certolizumab pegol, golimumab, infliximab, etanercept), and they are usually first choice of treatment when starting biological therapy. Another group of biologic agents approved for the treatment of AS are interleukin-17 (IL-17) inhibitors, such as secukinumab and ixekizumab...The selected therapy proved to be effective, leading to a notable reduction in overall pain and morning stiffness. Clinical improvement was measured by a decrease in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), which dropped from 5.3 prior to treatment to 2.95 after six months of therapy.

This study aims to identify key NET-associated molecular signatures in UC, develop diagnostic models based on NET-related biomarkers, and construct predictive models for response to anti-TNF-α therapies (infliximab and golimumab). A distinct NET-associated cluster was identified among patients with UC, exhibiting non-responsiveness to anti-TNF-α treatment. Diagnostic and prognostic models based on NET-associated genes hold promise for guiding clinical treatment strategies.

P=N/A, N=4000, Not yet recruiting, Pfizer

Studies reporting on infant infection rates, vaccination outcomes, and adverse events following in-utero or breastfeeding exposure to TNFi agents, including certolizumab pegol, adalimumab, infliximab, etanercept, and golimumab. The data indicate that TNFi does not increase the risk of severe infections or vaccine complications in infants, with the exception of the Bacille Calmette-Guerin vaccine, for which a more cautious approach is recommended. These findings reinforce the use of TNFi in women with inflammatory conditions who are pregnant or breastfeeding, providing benefits to both maternal and fetal health.

P2, N=80, Not yet recruiting, NYU Langone Health

P3, N=84, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Aug 2027 --> Feb 2027

P3, N=400, Recruiting, University of Nebraska | Trial completion date: Mar 2028 --> Mar 2029 | Trial primary completion date: Mar 2027 --> Mar 2028

P2 | N=34 | Not yet recruiting | Sponsor: University of Washington

Data from this proof-of-concept study suggest that combination therapy with guselkumab and golimumab might be more effective for ulcerative colitis than therapy with either drug alone. These findings require confirmation in larger trials.