Table of Contents
- Overview of the Golimumab trials
- Juvenile idiopathic arthritis studies
- Inflammatory bowel disease studies
- Other rheumatic disease studies
- What the trials measure
- Trial design and who may participate
Overview of the Golimumab trials
The trial data show that Golimumab is being studied in several interventional trials, which means participants receive a planned treatment and researchers compare outcomes across groups.[1] The studies cover both children and adults and focus on long-term inflammatory diseases, especially joint diseases and bowel diseases.[1][2]
Most of the listed studies are Phase 3 trials, with some Phase 2 and low-intervention studies.[1] The main purpose is to see how well Golimumab-related strategies work, how safe they are in the study setting, and whether they help prevent worsening of disease or support remission.[1][2]
Juvenile idiopathic arthritis studies
Two studies focus on juvenile idiopathic arthritis, a type of arthritis that starts in childhood.[1] One Phase 3 trial, MOVE-JIA, includes 150 children and adolescents with sustained inactive disease and compares two treatment withdrawal strategies with stable treatment using methotrexate and a tumor necrosis factor inhibitor (TNFi), which is a medicine group used in inflammatory disease.[1]
In MOVE-JIA, the main outcome is the proportion of participants who have a disease flare during the first 12 months.[1] The trial defines flare using a rise in JADAS-27, which is a disease activity score, plus active joints or agreement that the disease has clearly worsened and treatment needs to be intensified.[1]
The other juvenile idiopathic arthritis trial, NCT06618937, is also Phase 3 and includes 328 participants in clinical inactive disease who have had 6 months of inactive disease with medication and no subclinical inflammation, meaning hidden inflammation seen on tests or imaging.[1] This study compares early biomarker-guided withdrawal of antirheumatic agents with standard stable treatment over 12 months, and the main outcome is the rate of flares during the study period.[1]
Inflammatory bowel disease studies
Several studies look at ulcerative colitis and Crohn’s disease, which are long-term inflammatory bowel diseases.[2][3] In pediatric ulcerative colitis, one completed Phase 3 study with 42 participants tested Golimumab and measured clinical remission using the Mayo score, a standard score used to judge disease activity in ulcerative colitis.[3]
Another Phase 2 ulcerative colitis study includes 752 participants with moderately to severely active disease and compares Golimumab monotherapy with combination strategies that include guselkumab and JNJ-78934804.[4] Its main outcome is clinical remission at Week 48 compared with each monotherapy.[4]
The Crohn’s disease trial, NCT05242471, is a large Phase 2 study with 1096 participants who have moderately to severely active Crohn’s disease.[2] It studies Golimumab alone and in combination with guselkumab and JNJ-78934804, and it measures clinical remission and endoscopic response at Week 48, where endoscopic response means improvement seen on camera examination of the bowel.[2]
One low-intervention ulcerative colitis study with 100 participants compares anti-TNF treatment, including Golimumab, with vedolizumab and tofacitinib, and its main outcome is carotid intima-media thickness after 3 months.[5] Another Phase 3 ulcerative colitis trial with 60 participants studies platelet activation and coagulation, which are parts of blood clotting, in active and quiescent disease before and after treatment with tofacitinib or anti-TNF therapy such as Golimumab.[6]
Other rheumatic disease studies
Golimumab is also included in studies of psoriatic arthritis, peripheral spondyloarthritis, and rheumatoid arthritis.[7][8][9] These diseases affect the joints and can cause pain, swelling, stiffness, and reduced movement.[7][8][9]
In psoriatic arthritis, one Phase 3 study with 370 adults tests how far systemic immunosuppressive therapy can be tapered, which means reduced slowly, without the symptoms coming back.[7] The main outcomes are minimal disease activity at 12 months and mean PASDAS at month 12, both of which are ways to measure how well the disease is controlled.[7]
In peripheral spondyloarthritis, the SPARTACUS Phase 3 trial with 150 participants compares a standard step-up approach using conventional synthetic DMARDs with an early remission-induction strategy that starts with biological DMARDs, including Golimumab.[8] The goal is to see whether early TNF-alpha blockade can help more people reach clinical remission.[8]
In rheumatoid arthritis, one Phase 3 study with 300 participants compares a tailor-made management approach with routine care and includes Golimumab among several treatment options.[9] Its main clinical outcomes are the proportion of patients using a biologic or targeted synthetic DMARD after 10 months and disease activity over time, and it also includes a cost-effectiveness analysis using the ICER, which compares extra cost with extra benefit.[9]
Another rheumatoid arthritis study, NCT02714634, is a low-intervention trial with 286 participants who did not respond well enough to methotrexate or leflunomide.[10] It tests whether targeted therapies, including Golimumab, are more effective than triple therapy, and the main outcome is low disease activity with a low prednisone dose after at least 11 months.[10]
What the trials measure
The main outcomes in these studies are centered on disease control, not on laboratory drug details.[1][2][3][4][7][9][10]
Flare rate: how many patients have worsening disease after a period of control.[1][11]
Clinical remission: whether the disease becomes inactive or nearly inactive.[2][3][4][8]
Endoscopic response: improvement seen on bowel camera examination in Crohn’s disease.[2]
Minimal disease activity: a low level of disease activity used in psoriatic arthritis studies.[7]
Carotid intima-media thickness: a measure of artery wall thickness used as a cardiovascular risk marker.[5]
Platelet activation and coagulation: blood-clotting related measures in ulcerative colitis research.[6]
Trial design and who may participate
The studies use different designs, including comparisons between stable treatment and withdrawal, head-to-head comparisons with other treatment strategies, and combination therapy studies.[1][2][4][7][8][9][10]
Participation depends on the disease and trial rules, but the data show groups such as children with juvenile idiopathic arthritis, pediatric participants with ulcerative colitis, and adults with active or stable inflammatory joint disease or bowel disease.[1][2][3][4][7][8][9][10]
Some trials focus on people with sustained inactive disease or clinical inactive disease, while others require moderately to severely active disease or insufficient response to earlier treatment.[1][2][3][10]
