Simponi for Ulcerative Colitis
(OPAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand the long-term safety of Simponi for adults with moderate-to-severe ulcerative colitis, a condition that causes inflammation and sores in the colon. Participants will use either Simponi or another medication, thiopurines, which suppresses the immune system. The trial is suitable for those who have had moderate-to-severe ulcerative colitis for at least 3 months, have already been treated with Simponi or thiopurines, and are not on any other similar medications. As a Phase 4 trial, this study involves an FDA-approved treatment and focuses on how Simponi benefits more patients.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on other biologic agents or investigational drugs if you are in the Thiopurine cohort.
What is the safety track record for these treatments?
Research has shown that Simponi (golimumab) has been studied for safety over several years in individuals with conditions like rheumatoid arthritis and ulcerative colitis. In five studies, some patients experienced serious infections and other side effects, which were more common at higher doses. Overall, safety remained consistent over a five-year period.
For Thiopurines, including drugs like azathioprine and 6-mercaptopurine, research indicates they have been used safely to treat conditions like Crohn's disease. However, they can cause side effects such as skin irritation and should be handled with care. These medications have effectively helped patients achieve remission, meaning their symptoms improve or disappear.
Both treatments have been available for some time and are generally well-tolerated. However, like any medication, they carry risks, and it is important to discuss these with a healthcare provider.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for moderate-to-severe ulcerative colitis because they offer unique approaches compared to standard options like mesalamine, corticosteroids, and biologics like infliximab. Simponi, a biologic, stands out due to its targeted action on tumor necrosis factor-alpha (TNF-alpha), helping to reduce inflammation more effectively in some patients. Thiopurines, on the other hand, are immunomodulators that can help maintain remission by altering the immune system's response. These treatments provide alternative mechanisms of action that may offer better outcomes for patients who do not respond well to conventional therapies.
What is the effectiveness track record for Simponi and Thiopurines in treating moderate-to-severe ulcerative colitis?
Research shows that Simponi, also known as golimumab, effectively reduces symptoms in people with moderate-to-severe ulcerative colitis. Studies have found that after five years of treatment, many people continue to see improvements in their condition. Additionally, Simponi is generally well-tolerated, with few experiencing reactions at the injection site.
Research from several studies highlights the effectiveness of thiopurines in controlling ulcerative colitis. About 53% of patients remain symptom-free with long-term use of thiopurines, suggesting that thiopurines can reliably keep the condition stable. Both treatments offer promising options for managing this chronic illness.678910Who Is on the Research Team?
Janssen Biotech, Inc. Clinical Trial
Principal Investigator
Janssen Biotech, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are treated with Simponi to assess long-term safety risks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Simponi
- Thiopurines
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Biotech, Inc.
Lead Sponsor
Citations
Long-term golimumab persistence: Five-year treatment ...
Results. Golimumab retention rates at Year 5 were consistently high when used as 1st-line therapy (69.8%) and did not differ significantly ...
Five-Year SIMPONI Data Reported In Treatment Of Signs ...
After five years, 40 percent (172/434) of patients experienced a serious AE, and 14 percent of patients discontinued SIMPONI. The rates of ...
SIMPONI® (golimumab) Clinical Trials Information for HCPs
The rate of injection site reactions through Week 6 was 3.4% of SIMPONI‑treated UC patients compared with 1.5% in control‑treated patients. Adverse reactions ...
NCT00265096 | A Study of the Safety and Efficacy ...
The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of ...
Safety and Efficacy of Golimumab Administered ...
GOL 2 mg/kg administered IV at weeks 0, 4, and every 8 weeks significantly reduced the signs and symptoms of AS in adults.
SAFETY DATA SHEET Golimumab Formulation
Hygiene measures : If exposure to chemical is likely during typical use, provide eye flushing systems and safety showers close to the working place.
Simponi (golimumab) label - accessdata.fda.gov
The safety data described below are based on 5 pooled, randomized, double-blind, controlled. Phase 3 trials in patients with RA, PsA, and AS (Studies RA-1 ...
Golimumab 3-year safety update: an analysis of pooled data ...
Golimumab 100 mg showed numerically higher incidences of serious infections, demyelinating events and lymphoma than 50 mg; safety follow-up up to year 5 ...
SIMPONI® (golimumab) Treatment®
SIMPONI® (golimumab) is for RA, PsA, AS and UC treatment. See full Prescribing & Safety info including Boxed Warning.
Five-year Safety Data from 5 Clinical Trials ...
Objective. Assess 5-year golimumab (GOL) safety in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS).
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