Japan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
Peficitinib for Rheumatoid Arthritis: Real-World Safety and Effectiveness Study in Japan
Plain English Summary
Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis is a Not Applicable clinical trial sponsored by Astellas Pharma Inc studying Rheumatoid Arthritis (RA). This study observes how safe and effective peficitinib is for rheumatoid arthritis patients in everyday medical practice. It is for patients in Japan who are starting treatment with peficitinib for rheumatoid arthritis. Participation involves being treated with peficitinib and having your health monitored by your doctor. There are no alternative treatments being tested in this study; it focuses on the drug as prescribed by your doctor. The trial aims to enroll 3000 participants.
Official Summary
The objective of this study is to investigate the safety and effectiveness in routine clinical practice and actual clinical setting for all patients with rheumatoid arthritis (RA) treated with peficitinib.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients in Japan newly prescribed peficitinib for rheumatoid arthritis can join. There are no specific exclusion criteria mentioned, meaning most patients starting peficitinib are eligible. Age and specific health requirements are not detailed, but the focus is on patients initiating peficitinib treatment. This trial is studying Rheumatoid Arthritis (RA), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure how often side effects, serious infections, cancer, or death occur in patients taking peficitinib, giving an idea of the drug's overall safety profile. The specific primary outcome measures are: Safety assessed by frequency of adverse events (AEs) (Up to 52 weeks); Safety assessed by frequency of adverse drug reactions (ADRs) (Up to 52 weeks); Safety assessed by frequency of serious infections (Up to 156 weeks); Safety assessed by frequency of malignancy (Up to 156 weeks); Safety assessed by frequency of events leading to death (Up to 156 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This study is important because it will provide real-world data on the safety and effectiveness of peficitinib, helping to fill gaps in understanding how the drug performs outside of controlled clinic This research targets Rheumatoid Arthritis (RA), where improved treatment options are needed.
Investor Insight
This post-marketing surveillance study by Astellas Pharma Inc. aims to gather extensive real-world data on peficitinib, which can support its continued use and market position for rheumatoid arthritis The large enrollment target of 3000 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about potential side effects of peficitinib and how they will be monitored. Understand that this study involves routine medical care, with your doctor managing your treatment and collecting data. Your day-to-day experience will be similar to any patient receiving a new medication, with regular check-ups. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 3,000 participants
Interventions
- DRUG: Peficitinib — Oral
Primary Outcomes
- Safety assessed by frequency of adverse events (AEs) (Up to 52 weeks)
- Safety assessed by frequency of adverse drug reactions (ADRs) (Up to 52 weeks)
- Safety assessed by frequency of serious infections (Up to 156 weeks)
- Safety assessed by frequency of malignancy (Up to 156 weeks)
- Safety assessed by frequency of events leading to death (Up to 156 weeks)
Full Eligibility Criteria
Inclusion Criteria: * All patients with rheumatoid arthritis (RA) treated with peficitinib for the first time. Exclusion Criteria: * Not applicable.
Trial Locations
- Site JP00023, Aichi, Japan
- Site JP00005, Akita, Japan
- Site JP00002, Aomori, Japan
- Site JP00012, Chiba, Japan
- Site JP00038, Ehime, Japan
- Site JP00018, Fukui, Japan
- Site JP00040, Fukuoka, Japan
- Site JP00007, Fukushima, Japan
- Site JP00021, Gifu, Japan
- Site JP00010, Gunma, Japan
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT03971253?
NCT03971253 is a Not Applicable OBSERVATIONAL study titled "Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis." It is currently recruiting and is sponsored by Astellas Pharma Inc. The trial targets enrollment of 3000 participants.
What conditions does NCT03971253 study?
This trial investigates treatments for Rheumatoid Arthritis (RA). The primary condition under study is Rheumatoid Arthritis (RA).
What treatments are being tested in NCT03971253?
The interventions being studied include: Peficitinib (DRUG). Oral
What does Not Applicable mean for NCT03971253?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT03971253?
This trial is currently "Recruiting." It started on 2019-09-02. The estimated completion date is 2026-05-31.
Who is sponsoring NCT03971253?
NCT03971253 is sponsored by Astellas Pharma Inc. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT03971253?
The trial aims to enroll 3000 participants. The trial is currently recruiting and accepting new participants.
How is NCT03971253 designed?
This is a observational study.
What are the primary outcomes being measured in NCT03971253?
The primary outcome measures are: Safety assessed by frequency of adverse events (AEs) (Up to 52 weeks); Safety assessed by frequency of adverse drug reactions (ADRs) (Up to 52 weeks); Safety assessed by frequency of serious infections (Up to 156 weeks); Safety assessed by frequency of malignancy (Up to 156 weeks); Safety assessed by frequency of events leading to death (Up to 156 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT03971253 being conducted?
This trial is being conducted at 20 sites, including Aichi; Akita; Aomori; Chiba and 16 more sites (Japan).
Where can I find official information about NCT03971253?
The official record for NCT03971253 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT03971253. This government database provides the most up-to-date and detailed information about the trial.
What is NCT03971253 testing in simple terms?
This study observes how safe and effective peficitinib is for rheumatoid arthritis patients in everyday medical practice. It is for patients in Japan who are starting treatment with peficitinib for rheumatoid arthritis.
Why is this trial significant?
This study is important because it will provide real-world data on the safety and effectiveness of peficitinib, helping to fill gaps in understanding how the drug performs outside of controlled clinic
What are the potential risks of participating in NCT03971253?
Common risks include adverse events, which are any unwanted medical occurrences during treatment. More serious risks monitored include severe infections, the development of cancer, and events that could lead to death. Adverse drug reactions, which are specifically caused by the medication, will also be tracked. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT03971253?
Ask your doctor about potential side effects of peficitinib and how they will be monitored. Understand that this study involves routine medical care, with your doctor managing your treatment and collecting data. Your day-to-day experience will be similar to any patient receiving a new medication, with regular check-ups. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT03971253 signal from an investment perspective?
This post-marketing surveillance study by Astellas Pharma Inc. aims to gather extensive real-world data on peficitinib, which can support its continued use and market position for rheumatoid arthritis This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves being treated with peficitinib and having your health monitored by your doctor. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Rheumatoid Arthritis (RA) Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.