Rheumatoid ArthritisLORMYFNCT05424393
Real-World Study on Long-term Treatment With YISAIPU for Fujian RA Patients
An observational study of Rheumatoid Arthritis, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
Through real-world observation, understanding clinical efficacy and safety of treatment with YISAIPU (etanercept biosimilar) for RA patients of Fujian Province for three years Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- YISAIPU® ( An etanercept biosimilar) and csDMARDs
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RA patients in routine clinical practice environments
Who may be able to join
- Meet the ACR revised RA classification criteria(2010);
- Disease duration is more than or equal to 6 weeks;
- DAS28-CRP>2.6;
- Patient is eligible for TNF inhibitors treatment according to the judgment of the attending doctor in clinical practice;
- A written informed consent form must be provided with a signed and signed date prior to the commencement of any study specific procedure.
Who cannot join
- Patient has contraindication(s) to the use of fusion-protein type of TNF inhibitor;
- Patient is participating in other ongoing drug clinical trials;
- Patient whose LTBI screening result is positive, or had not received standard anti-TB treatment for TB history, is unwilling to take prophylactic treatment for TB;
- Patient with HBV infection and positive for HBV replication (not up to active replication) is not willing to receive anti-HBV treatment;
- Anti-HCV antibody is positive and HCV-RNA is positive, and patient is unwilling to start anti-HCV treatment;
- Other reasons the researchers think the patient is not eligible for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Yan Li, PHD/MD, 8615960263763, liy010203@163.com
About this study
Official title: Long-term Real-world Prospectiv Observational Study on Maintenance Treatment With YISAIPU, an Etanercept Biosimilar, for Patients Wih Rheumatoid Arthritis of Fujian Province of China
Through real-world observation, understanding clinical efficacy and safety of treatment with YISAIPU (etanercept biosimilar) for RA patients of Fujian Province for three years
Read the detailed description
This is a multi-center, prospective, real-world observational study. Patients who have completed 6 months of induction therapy (YISAIPU 50mg / week ± csDMARDs) and achieved clinical remission or low disease activity will be observed for 2.5 years. During the maintenance period, through full communication between doctors and patients, YISAIPU 50 mg/wk or YISAIPU 25 mg/wk will be chosen as maintenance treatment. The clinical efficacy evaluation parameters include DAS28, HAQ-DI, modified Sharp score, continuous medication rate, and the recurrence rate of rheumatoid arthritis. Drug safety evaluation will include the incidence of adverse drug reactions and adverse drug events, the incidence of serious adverse events, and the incidence of adverse events leading to the reduction or withdrawal of YISAIPU due to adverse events. Exploratory observations wil include: (1) the incidence, clinical characteristics and disease changes of Interstitial Lung Disease, (2) the baseline abnormal rate and 3-year change of carotid intima-media thickness.
- Conditions
- Rheumatoid Arthritis
- Being tested
- YISAIPU® ( An etanercept biosimilar), csDMARDs
- Keywords
- clincal remission; low disease activity
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YISAIPU® ( An etanercept biosimilar)Drug
Also called a recombinant tumor necrosis factor receptor-Fc fusion protein, rhTNFR:Fc
YISAIPU®, an etanercept biosimilar produced by 3SBio Inc., is a TNF-α inhibitor targeting soluble TNF-α to inhibit its interaction with cell-surface receptors. It has been widely used in clinical practice for 17 years in China. According to the prescription information, YISAIPU should be given as 25mg, biw, pc.
csDMARDsDrug
csDMARDs include methotrexate, sulfasalazine, hydroxychloroquine and leflunomide The use of csDMARDs complies with clinical routine practice and treatment strategy of treat-to-target.
| Study group | Role | What they receive |
|---|---|---|
| RA Patients receiving routine treatment | During the induction phase, the dose of YISAIPU is 50mg/wk. Patients who achieved clinical remission or low activity after 24 weeks of induction treatment can enter the maintenance phase. Those who fail to succeed in induction treatment will not be followed up. During the maintenance phase, the dose of YISAIPU could be either 50mg/wk or 25mg/wk. Patients will be followed up regularly for 2.5 years. Receives: Drug: YISAIPU® ( An etanercept biosimilar); Drug: csDMARDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical remission defined by DAS28
Clinical efficacy: Clinical remission rate achieved at 48 weeks
Measured: 48 weeks
Secondary outcomes (7)
clinical remission rate of RA at weeks 24, 96 and 144
clinical remission rate of RA at weeks 24, 96 and 144
Measured: weeks 24, 96 and 144
low disease activity rate of RA at weeks 24, 48, 96 and 144
low disease activity rate of RA at weeks 24, 48, 96 and 144
Measured: weeks 24, 48, 96 and 144
joint function remission (HAQ ≤0.5) rate at weeks 24, 48, 96 and 144
joint function remission (HAQ ≤0.5) rate at weeks 24, 48, 96 and 144
Measured: weeks 24, 48, 96 and 144
improvement of radiographic progression of both hands evaluated by modified SHARP score at weeks 96 and 144
improvement of radiographic progression of both hands evaluated by modified SHARP score at weeks 96 and 144
Measured: weeks 24, 48, 96 and 144
scores of synovitis and bone erosion evaluated by ultrasound at week 24, 48, 96 and 144
scores of synovitis and bone erosion evaluated by ultrasound at week 24, 48, 96 ，144
Measured: weeks 24, 48, 96 and 144
rates of severe adverse reactions rate and severe adverse events at week 24, 48, 96 and 144
rates of severe adverse reactions rate and severe adverse events at week 24, 48, 96 and 144
Measured: weeks 24, 48, 96 and 144
changes of carotid intima-media thickness at weeks 48 and 144
changes of carotid intima-media thickness at weeks 48 and 144
Measured: weeks 48 and 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start4 Mar 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guixiu Shi, MD PHD, Study director, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424393
- Sponsor's protocol ID
- FJ_RA_RWS_2021
- Acronym
- LORMYF
- Status last verified
- Mar 2022
- First submitted
- 15 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: share the study protocol
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Real-world Prospectiv Observational Study on Maintenance Treatment With YISAIPU, an Etanercept Biosimilar, for Patients Wih Rheumatoid Arthritis of Fujian Province of China
- ClinicalTrials.gov ID
- NCT05424393
- Acronym / sponsor ID
- LORMYF / FJ_RA_RWS_2021
- Conditions
- Rheumatoid Arthritis
- Keywords
- clincal remission; low disease activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Through real-world observation, understanding clinical efficacy and safety of treatment with YISAIPU (etanercept biosimilar) for RA patients of Fujian Province for three years
Detailed description
This is a multi-center, prospective, real-world observational study. Patients who have completed 6 months of induction therapy (YISAIPU 50mg / week ± csDMARDs) and achieved clinical remission or low disease activity will be observed for 2.5 years. During the maintenance period, through full communication between doctors and patients, YISAIPU 50 mg/wk or YISAIPU 25 mg/wk will be chosen as maintenance treatment. The clinical efficacy evaluation parameters include DAS28, HAQ-DI, modified Sharp score, continuous medication rate, and the recurrence rate of rheumatoid arthritis. Drug safety evaluation will include the incidence of adverse drug reactions and adverse drug events, the incidence of serious adverse events, and the incidence of adverse events leading to the reduction or withdrawal of YISAIPU due to adverse events. Exploratory observations wil include: (1) the incidence, clinical characteristics and disease changes of Interstitial Lung Disease, (2) the baseline abnormal rate and 3-year change of carotid intima-media thickness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA Patients receiving routine treatment | – | Drug: YISAIPU® ( An etanercept biosimilar), Drug: csDMARDsDuring the induction phase, the dose of YISAIPU is 50mg/wk. Patients who achieved clinical remission or low activity after 24 weeks of induction treatment can enter the maintenance phase. Those who fail to succeed in induction treatment will not be followed up. During the maintenance phase, the dose of YISAIPU could be either 50mg/wk or 25mg/wk. Patients will be followed up regularly for 2.5 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA patients in routine clinical practice environments
Key inclusion criteria (5 listed)
- Meet the ACR revised RA classification criteria(2010);
- Disease duration is more than or equal to 6 weeks;
- DAS28-CRP>2.6;
- Patient is eligible for TNF inhibitors treatment according to the judgment of the attending doctor in clinical practice;
- A written informed consent form must be provided with a signed and signed date prior to the commencement of any study specific procedure.
Key exclusion criteria (6 listed)
- Patient has contraindication(s) to the use of fusion-protein type of TNF inhibitor;
- Patient is participating in other ongoing drug clinical trials;
- Patient whose LTBI screening result is positive, or had not received standard anti-TB treatment for TB history, is unwilling to take prophylactic treatment for TB;
- Patient with HBV infection and positive for HBV replication (not up to active replication) is not willing to receive anti-HBV treatment;
- Anti-HCV antibody is positive and HCV-RNA is positive, and patient is unwilling to start anti-HCV treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YISAIPU® ( An etanercept biosimilar)Also: a recombinant tumor necrosis factor receptor-Fc fusion protein, rhTNFR:FcYISAIPU®, an etanercept biosimilar produced by 3SBio Inc., is a TNF-α inhibitor targeting soluble TNF-α to inhibit its interaction with cell-surface receptors. It has been widely used in clinical practice for 17 years in China. According to the prescription information, YISAIPU should be given as 25mg, biw, pc. | Drug | RA Patients receiving routine treatment |
| csDMARDscsDMARDs include methotrexate, sulfasalazine, hydroxychloroquine and leflunomide The use of csDMARDs complies with clinical routine practice and treatment strategy of treat-to-target. | Drug | RA Patients receiving routine treatment |
Primary outcome
clinical remission defined by DAS28
Time frame: 48 weeks
Clinical efficacy: Clinical remission rate achieved at 48 weeks
7 secondary outcomes
clinical remission rate of RA at weeks 24, 96 and 144
Time frame: weeks 24, 96 and 144
low disease activity rate of RA at weeks 24, 48, 96 and 144
Time frame: weeks 24, 48, 96 and 144
joint function remission (HAQ ≤0.5) rate at weeks 24, 48, 96 and 144
Time frame: weeks 24, 48, 96 and 144
improvement of radiographic progression of both hands evaluated by modified SHARP score at weeks 96 and 144
Time frame: weeks 24, 48, 96 and 144
scores of synovitis and bone erosion evaluated by ultrasound at week 24, 48, 96 and 144
Time frame: weeks 24, 48, 96 and 144
rates of severe adverse reactions rate and severe adverse events at week 24, 48, 96 and 144
Time frame: weeks 24, 48, 96 and 144
changes of carotid intima-media thickness at weeks 48 and 144
Time frame: weeks 48 and 144
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Yes. share the study protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guixiu Shi, MD PHD study director
The First Affiliated Hospital of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guixiu Shi, MD PHD (8613600932661, gshi@xmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical remission defined by DAS28 (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.