Golimumab Clinical Trials

What Is Golimumab?

Golimumab is an FDA-approved medication for ulcerative colitis (UC), rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It belongs to a class of medicines known as tumor necrosis factor (TNF) inhibitors. TNF is a protein in the body that can cause inflammation. By inhibiting TNF-alpha, golimumab helps to reduce inflammation in various conditions.

Beyond its approved uses, golimumab is also being investigated for other conditions. These include autoimmune inner ear disease (AIED), where it is being tested as an intratympanic injection, and chronic sarcoidosis. Studies have shown that individuals may respond differently to treatment with TNF inhibitors.

Uses and Conditions Under Study

Golimumab is being studied for a range of inflammatory and autoimmune conditions, reflecting its mechanism as a tumor necrosis factor (TNF) inhibitor.

• Arthritis and Spondyloarthritis: A significant number of trials, totaling 51, focus on various forms of arthritis and spondyloarthritis. These include Rheumatoid Arthritis (17 trials), Ankylosing Spondylitis (7 trials), Psoriatic Arthritis (7 trials), and Axial Spondyloarthritis (4 trials). These conditions are characterized by chronic inflammation of the joints and spine, which can lead to pain, stiffness, and progressive joint damage. By targeting TNF, golimumab aims to reduce this inflammation, alleviate symptoms, and potentially slow disease progression.

• Ulcerative Colitis: Another major area of investigation is inflammatory bowel disease, specifically Ulcerative Colitis. This chronic condition causes inflammation of the colon's lining, leading to debilitating symptoms such as bloody diarrhea, abdominal pain, and urgent bowel movements. Golimumab is being studied in 24 trials for this condition, with the goal of managing the immune response and reducing inflammation in the gastrointestinal tract to improve patients' quality of life.

• Diabetes Mellitus, Type 1: This autoimmune disease affects the body's ability to produce insulin, requiring lifelong management. Golimumab's role as an immune modulator is being explored to understand its potential impact on the disease progression, with 3 trials investigating this condition as a possible therapeutic approach.

Dosing

Golimumab has been studied in various dosage forms and regimens. It is commonly administered as a subcutaneous injection or an intravenous infusion.

For subcutaneous administration, common strengths studied include 50 mg and 100 mg, often given every four weeks (q4w) or monthly (QM). Some trials also investigated higher initial doses such as 200 mg or 400 mg, followed by maintenance doses of 100 mg or 50 mg, respectively. Devices like prefilled syringes and the Smartject™ device have been used for subcutaneous delivery.

Intravenous administration has been studied with weight-based dosing, including 1 mg/kg, 2 mg/kg, and 4 mg/kg. For example, a 2 mg/kg intravenous dose has been investigated, sometimes in combination with subcutaneous maintenance doses. Golimumab has been studied both as monotherapy and in combination with other medications, such as methotrexate, for conditions like rheumatoid arthritis.

Side Effects

The most common side effect reported in clinical trials for Golimumab was upper respiratory tract infection, which occurred in 9.1% of patients taking the drug, compared to 7.3% of those on placebo. Nasopharyngitis (common cold) was also frequently observed, affecting 8.6% of patients on Golimumab versus 6.4% on placebo.

Other common side effects included:

• Headache: 6.4% of patients on Golimumab experienced headaches, compared to 5.8% on placebo.
• Increased alanine aminotransferase (a liver enzyme): 6.0% of patients on Golimumab had elevated levels, versus 4.1% on placebo.
• Bronchitis: 5.0% of patients on Golimumab experienced bronchitis, compared to 4.1% on placebo.
• Nausea: 4.9% of patients on Golimumab reported nausea, compared to 3.8% on placebo.
• Sinusitis: 4.9% of patients on Golimumab experienced sinusitis, compared to 4.8% on placebo.

Clinical Trial Results

Rheumatoid Arthritis (RA)

In a study (NCT00207714) evaluating Golimumab in patients with active rheumatoid arthritis, various doses were tested. At Week 16, a median improvement of 33.3 on the ACR-N index was observed across combined Golimumab groups, compared to no improvement (0.0) in the placebo group. For example, 21 participants receiving Golimumab 50 mg every four weeks achieved an American College of Rheumatology 20 (ACR 20) response, while 13 participants in the placebo group (who later crossed over to infliximab) achieved this response.

Another study () focused on patients with active disease despite methotrexate therapy. At Week 24, approximately 35% of patients (106 out of an estimated 300) receiving Golimumab plus methotrexate achieved an ACR 20 response, compared to approximately 12% of patients (37 out of an estimated 300) on placebo plus methotrexate. Patients treated with Golimumab plus methotrexate also showed a median improvement of 0.4375 in their Health Assessment Questionnaire (HAQ) score at Week 24, indicating better physical function, compared to a median improvement of 0.1250 in the placebo plus methotrexate group.

In a study () showed that approximately 47% of patients (140 out of an estimated 300) receiving Golimumab achieved an ACR 20 response at Week 14, compared to approximately 3% of patients (10 out of an estimated 300) on placebo. Furthermore, approximately 36% of patients (107 out of an estimated 300) with significant psoriasis skin involvement treated with Golimumab achieved a 75% improvement in their Psoriasis Area and Severity Index (PASI 75) score at Week 14, versus approximately 1% of patients (2 out of an estimated 300) on placebo. Golimumab treatment also resulted in a mean change of -0.09 in total radiographic scores of the hands and feet at Week 24, suggesting less progression of joint damage, compared to a mean change of 0.27 in the placebo group.

One ongoing Phase 3 study, NCT05669833, is comparing Guselkumab to Golimumab in patients with Psoriatic Arthritis (PsA) who have not responded adequately to a previous TNF inhibitor. This open-label, randomized trial, sponsored by the University of Pennsylvania, seeks to enroll 63 patients to determine if switching to a selective IL-23 inhibitor is more effective than switching to a second TNF inhibitor. Participants may receive Guselkumab 100mg every four or eight weeks, or Golimumab 50mg every four weeks.

Another study, NCT05313620, is a Phase 4 post-authorization trial investigating the effect of Tofacitinib on coagulation and platelet function, and its role in thromboembolic events in patients with Ulcerative Colitis. This study, sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, includes patients treated with anti-TNFα drugs such as Golimumab, Infliximab, or Adalimumab, alongside those treated with JAK-inhibitors or healthy controls. It aims to enroll 30 participants.

For individuals with Rheumatoid Arthritis, a Phase 3 study (NCT03414502) is underway to identify predictors of response to various disease-modifying antirheumatic drugs (DMARDs), including Golimumab. Sponsored by the University of Nebraska, this study plans to enroll 400 patients to better understand how different treatments, such as Golimumab therapy, impact disease progression and patient outcomes.

Additionally, the "CHronic Nonbacterial Osteomyelitis International Registry" (NCT04725422) is establishing a prospective registry for Chronic Recurrent Multifocal Osteomyelitis (CRMO) and Chronic Nonbacterial Osteomyelitis (CNO). This long-term study, sponsored by Seattle Children's Hospital, aims to investigate the natural history of these conditions and patient responses to different clinical managements, which may include treatments like Golimumab, over a 10-year period. The registry has a large enrollment target of 2000 participants.

Where to Participate

Clinical research involving Golimumab is conducted across a wide geographic area, making participation accessible to many. Studies are currently recruiting in 15 cities across 11 states, with a total of 15 sites available for enrollment.

Top locations with active studies include:

• Omaha, Nebraska (2 sites)
• Plant City, Florida (1 site)
• Riverview, Florida (1 site)
• Lilburn, Georgia (1 site)
• Worcester, Massachusetts (1 site)
• New York, New York (1 site)
• Blue Ash, Ohio (1 site)
• Wheelersburg, Ohio (1 site)
• Philadelphia, Pennsylvania (1 site)
• Crossville, Tennessee (1 site)

Eligibility criteria for these trials generally include individuals aged 18 to 80 years, and participants of all genders are welcome. Some studies also include healthy volunteers, and certain trials are open to children.

Development Timeline

The journey of Golimumab in clinical development began on September 21, 2005, marking the start of extensive research into its therapeutic potential. Since then, a total of 102 clinical trials have been initiated, enrolling over 35,502 participants to date, with the latest trial projected to conclude in March 2026.

Early development saw studies in conditions such as IBS-C and hyperphosphatemia. Over time, the research pipeline significantly expanded, focusing primarily on a broad spectrum of autoimmune and inflammatory diseases. Key conditions explored include Ulcerative Colitis, various forms of Arthritis (Rheumatoid, Psoriatic, Juvenile Idiopathic), Ankylosing Spondylitis, and other Spondyloarthropathies. The development also branched into areas like Type 1 Diabetes Mellitus, Major Depressive Disorder, and Psoriasis, demonstrating a wide-ranging investigation into its effects.

The development program has progressed through all clinical phases, with a significant number of studies reaching advanced stages. There have been 31 Phase 3 trials and 22 Phase 4 trials, indicating a strong focus on confirming efficacy and safety, and on post-marketing surveillance. Janssen Research & Development, LLC, along with Centocor, Inc. and Merck Sharp & Dohme LLC, have been prominent sponsors, driving much of this comprehensive research effort.