Rheumatoid Arthritis (RA)MTX-RWS-INCT07463937
A RWS of SC MTX in Chinese RA Patients
An observational study of Rheumatoid Arthritis (RA), run by Peking University People's Hospital at 1 site in China.
Trial summary
Design: A prospective, single-arm, multicenter, real-world study that does not interfere with the patient's treatment plan Primary Objective: 1. To evaluate the effectiveness and safety of subcutaneous Methotrexate (MTX) in RA patients in a real-world setting; Exploratory Objectives: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- Type of treatment
- Injection or infusion
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2024to 31 Dec 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study includes adult RA patients treated with subcutaneous MTX.
Who may be able to join
- Adult patients diagnosed with rheumatoid arthritis according to the 1987 ACR or 2010 ACR/EULAR classification criteria.
- Patients who, after clinical evaluation, are starting or preparing to start subcutaneous methotrexate treatment, with expected benefits outweighing the risks.
- Patients who agree to participate in the study, can comply with follow-up, and sign the informed consent form.
- Additionally, subjects meeting the following inclusion criteria can be assigned to Cohort 2:
- Diagnosed with interstitial lung disease (ILD) or interstitial lung abnormalities (ILAs) prior to or at the time of enrollment;
- Have baseline forced vital capacity (FVC) results at the time of enrollment, with FVC being 50% or more of the predicted value.
Show all 11Show fewer
- Subjects meeting the following inclusion criteria can be assigned to Cohort 3:
- 1. Have a clear clinical subtype result at the time of enrollment.
- Subjects meeting the following inclusion criteria can be assigned to Cohort 4:
- Diagnosed with stable coronary artery disease prior to or at the time of enrollment, including those with a history of coronary artery intervention or coronary artery bypass grafting for at least one year, or angiographic evidence of ≥50% stenosis in at least one coronary artery without the need for revascularization;
- C-reactive protein (CRP) or high-sensitivity CRP (hsCRP) ≥2 mg/L.
Who cannot join
- Pregnant or breastfeeding women;
- Serum creatinine: Female patients with serum creatinine >1.4 mg/dL (124 μmol/L); male patients with serum creatinine >1.6 mg/dL (141 μmol/L); patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN);
- Platelet count <80×10^9/L; white blood cell (WBC) count <3.5×10^9/L; total bilirubin >1.5 times the ULN;
- Presence of severe, uncontrolled comorbid conditions, such as (but not limited to) neurological, cardiovascular, hepatic, renal, gastrointestinal, or endocrine diseases, which in the investigator's judgment may interfere with the patient's participation in the study;
- Patients with a history of malignancy within the past 5 years;
- Cardiac diseases: decompensated heart failure or refractory hypertension (hypertension that cannot be controlled to target levels of systolic and diastolic blood pressure despite lifestyle modifications and adequate doses of at least three antihypertensive drugs, including diuretics);
Show all 12Show fewer
- Patients with significant or laboratory-confirmed immunodeficiency syndromes;
- Patients with severe acute or chronic infections;
- Patients with pre-existing hematologic disorders, such as myelodysplasia, leukopenia, thrombocytopenia, or anemia;
- Patients allergic to the study-related drug;
- Patients with a history of drug abuse, mental illness, or alcoholism, who cannot cooperate with clinical researchers;
- Other patients deemed unsuitable for participation in the study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xu LIU, MD, 010-88325223, liuxupkupku@163.com
About this study
Official title: A Real-World Study of Subcutaneous Methotrexate (Pre-filled) in Chinese Rheumatoid Arthritis (RA) Patients
Design: A prospective, single-arm, multicenter, real-world study that does not interfere with the patient's treatment plan
Primary Objective:
Read more
- To evaluate the effectiveness and safety of subcutaneous Methotrexate (MTX) in RA patients in a real-world setting;
Exploratory Objectives:
- To assess the safety and effectiveness of subcutaneous MTX in RA patients with interstitial lung disease (ILD) or interstitial lung abnormalities (ILAs), and stable coronary artery disease (SCAD) in a real-world setting;
- To evaluate the effectiveness and safety of subcutaneous MTX in RA patients with different clinical subtypes.
The study includes adult RA patients treated with subcutaneous MTX, divided into the following four cohorts based on comorbidities and clinical subtypes:
Cohort 1: Chinese RA patients receiving subcutaneous MTX treatment (8,000 cases) Cohort 2: Chinese RA patients with ILD or ILAs receiving subcutaneous MTX treatment (200 cases) Cohort 3: Chinese RA patients with clinical subtype results at enrollment, receiving subcutaneous MTX treatment (1,500 cases) Cohort 4: Chinese RA arthritis patients with SCAD receiving subcutaneous MTX treatment (300 cases)
- Conditions
- Rheumatoid Arthritis (RA)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Chinese RA patients receiving subcutaneous MTX treatment (8,000 cases) | |
| Cohort 2 | Chinese RA patients with ILD or ILAs receiving subcutaneous MTX treatment (200 cases) | |
| Cohort 3 | Chinese RA patients with clinical subtype results at enrollment, receiving subcutaneous MTX treatment (1,500 cases) | |
| Cohort 4 | Chinese RA arthritis patients with SCAD receiving subcutaneous MTX treatment (300 cases) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20 response rate at 24 weeks
The ACR20 involves following indicators: tender joint count (TJC, 68 major joints), swollen joint count (SJC, 66 major joints), Visual Analog Score for pain (VAS), Patient Global Assessment (PGA), Estimator Global Assessment (EGA), Health Assessment Questionnaire-Disability Index (HAQ-DI), Acute-Phase Reactant (Erythrocyte Sedimentation Rate or C-Reactive Protein).
ACR20 response requires: ① ≥20% improvement in TJC; ② ≥20% improvement in SJC; ③ ≥20% improvement in 3 of following 5 indicators: VAS, PGA, EGA, HAQ-DI, Acute-Phase Reactant (ESR or CRP).
Measured: 24 weeks after enrollment
Secondary outcomes (7)
ACR20 response rate at 4 and 12 weeks
The ACR20 involves following indicators: tender joint count (TJC, 68 major joints), swollen joint count (SJC, 66 major joints), Visual Analog Score for pain (VAS), Patient Global Assessment (PGA), Estimator Global Assessment (EGA), Health Assessment Questionnaire-Disability Index (HAQ-DI), Acute-Phase Reactant (Erythrocyte Sedimentation Rate or C-Reactive Protein).
ACR20 response requires: ① ≥20% improvement in TJC; ② ≥20% improvement in SJC; ③ ≥20% improvement in 3 of following 5 indicators: VAS, PGA, EGA, HAQ-DI, Acute-Phase Reactant (ESR or CRP).
Measured: 4 and 12 weeks after enrollment
ACR50 response rates at 4, 12, and 24 weeks
The ACR50 involves following indicators: tender joint count (TJC, 68 major joints), swollen joint count (SJC, 66 major joints), Visual Analog Score for pain (VAS), Patient Global Assessment (PGA), Estimator Global Assessment (EGA), Health Assessment Questionnaire-Disability Index (HAQ-DI), Acute-Phase Reactant (Erythrocyte Sedimentation Rate or C-Reactive Protein).
ACR50 response requires: ① ≥50% improvement in TJC; ② ≥50% improvement in SJC; ③ ≥50% improvement in 3 of following 5 indicators: VAS, PGA, EGA, HAQ-DI, Acute-Phase Reactant (ESR or CRP).
Measured: 4, 12, and 24 weeks after enrollment
ACR70 response rates at 4, 12, and 24 weeks
The ACR70 involves following indicators: tender joint count (TJC, 68 major joints), swollen joint count (SJC, 66 major joints), Visual Analog Score for pain (VAS), Patient Global Assessment (PGA), Estimator Global Assessment (EGA), Health Assessment Questionnaire-Disability Index (HAQ-DI), Acute-Phase Reactant (Erythrocyte Sedimentation Rate or C-Reactive Protein).
ACR70 response requires: ① ≥70% improvement in TJC; ② ≥70% improvement in SJC; ③ ≥70% improvement in 3 of following 5 indicators: VAS, PGA, EGA, HAQ-DI, Acute-Phase Reactant (ESR or CRP).
Measured: 4, 12, and 24 weeks after enrollment
Improvement in DAS28 scores at 4, 12, and 24 weeks compared to baseline.
The DAS28 includes DAS28-ESR and DAS28-CRP. The DAS28-ESR score involves four indicators: tender joint count (TJC, 28 major joints), swollen joint count (SJC, 28 major joints), erythrocyte sedimentation rate (ESR), and patient global assessment (PGA).
Calculation formula: DAS28-ESR (points) = 0.56√TJC28(points) + 0.28√SJC28(points) + 0.70×ln［ESR(mm/1h）］+ 0.014×［PGA (points)］ The DAS28-CRP score involves four indicators: tender joint count (TJC, 28 major joints), swollen joint count (SJC, 28 major joints), C-Reactive Protein (CRP), and patient global assessment (PGA).
Calculation formula: DAS28-CRP (points) = 0.56√TJC28(points) + 0.28√SJC28(points) + 0.36×ln［CRP(mg/L）］+ 0.014×［PGA (points)］+0.96
Measured: 4, 12, and 24 weeks after enrollment compared to baseline
Improvement in CDAI scores at 4, 12, and 24 weeks compared to baseline
The CDAI involves following indicators: tender joint count (TJC, 28 major joints), swollen joint count (SJC, 28 major joints), patient global assessment (PGA) and evaluator global assessment (EGA).
Calculation formula: CDAI (points) = TJC28(points) + SJC28(points) + PGA (points) + EGA(points)
Measured: 4, 12, and 24 weeks after enrollment compared to baseline
Improvement in patient global assessment (PGA), Visual Analog Score for pain (VAS), and evaluator global assessment (EGA) at 4, 12, and 24 weeks compared to baseline.
Improvement in patient global assessment (PGA), Visual Analog Score for pain (VAS), and evaluator global assessment (EGA) at 4, 12, and 24 weeks compared to baseline.
Measured: 4, 12, and 24 weeks after enrollment compared to baseline
Safety endpoints within 24 weeks, including the number and incidence of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs).
Safety endpoints within 24 weeks, including the number and incidence of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs).
Measured: 4, 12, and 24 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start3 Sep 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- 10,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhanguo Li, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463937
- Sponsor's protocol ID
- MTX-RWS-I
- Acronym
- MTX-RWS-I
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study of Subcutaneous Methotrexate (Pre-filled) in Chinese Rheumatoid Arthritis (RA) Patients
- ClinicalTrials.gov ID
- NCT07463937
- Acronym / sponsor ID
- MTX-RWS-I / MTX-RWS-I
- Conditions
- Rheumatoid Arthritis (RA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Mar 2026 (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.
Design: A prospective, single-arm, multicenter, real-world study that does not interfere with the patient's treatment plan
Primary Objective:
- To evaluate the effectiveness and safety of subcutaneous Methotrexate (MTX) in RA patients in a real-world setting;
Exploratory Objectives:
- To assess the safety and effectiveness of subcutaneous MTX in RA patients with interstitial lung disease (ILD) or interstitial lung abnormalities (ILAs), and stable coronary artery disease (SCAD) in a real-world setting;
- To evaluate the effectiveness and safety of subcutaneous MTX in RA patients with different clinical subtypes.
The study includes adult RA patients treated with subcutaneous MTX, divided into the following four cohorts based on comorbidities and clinical subtypes:
Cohort 1: Chinese RA patients receiving subcutaneous MTX treatment (8,000 cases) Cohort 2: Chinese RA patients with ILD or ILAs receiving subcutaneous MTX treatment (200 cases) Cohort 3: Chinese RA patients with clinical subtype results at enrollment, receiving subcutaneous MTX treatment (1,500 cases) Cohort 4: Chinese RA arthritis patients with SCAD receiving subcutaneous MTX treatment (300 cases)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Chinese RA patients receiving subcutaneous MTX treatment (8,000 cases) |
| Cohort 2 | – | –Chinese RA patients with ILD or ILAs receiving subcutaneous MTX treatment (200 cases) |
| Cohort 3 | – | –Chinese RA patients with clinical subtype results at enrollment, receiving subcutaneous MTX treatment (1,500 cases) |
| Cohort 4 | – | –Chinese RA arthritis patients with SCAD receiving subcutaneous MTX treatment (300 cases) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes adult RA patients treated with subcutaneous MTX.
Key inclusion criteria (11 listed)
- Adult patients diagnosed with rheumatoid arthritis according to the 1987 ACR or 2010 ACR/EULAR classification criteria.
- Patients who, after clinical evaluation, are starting or preparing to start subcutaneous methotrexate treatment, with expected benefits outweighing the risks.
- Patients who agree to participate in the study, can comply with follow-up, and sign the informed consent form.
- Additionally, subjects meeting the following inclusion criteria can be assigned to Cohort 2:
- Diagnosed with interstitial lung disease (ILD) or interstitial lung abnormalities (ILAs) prior to or at the time of enrollment;
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding women;
- Serum creatinine: Female patients with serum creatinine >1.4 mg/dL (124 μmol/L); male patients with serum creatinine >1.6 mg/dL (141 μmol/L); patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN);
- Platelet count <80×10^9/L; white blood cell (WBC) count <3.5×10^9/L; total bilirubin >1.5 times the ULN;
- Presence of severe, uncontrolled comorbid conditions, such as (but not limited to) neurological, cardiovascular, hepatic, renal, gastrointestinal, or endocrine diseases, which in the investigator's judgment may interfere with the patient's participation in the study;
- Patients with a history of malignancy within the past 5 years;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ACR20 response rate at 24 weeks
Time frame: 24 weeks after enrollment
The ACR20 involves following indicators: tender joint count (TJC, 68 major joints), swollen joint count (SJC, 66 major joints), Visual Analog Score for pain (VAS), Patient Global Assessment (PGA), Estimator Global Assessment (EGA), Health Assessment Questionnaire-Disability Index (HAQ-DI), Acute-Phase Reactant (Erythrocyte Sedimentation Rate or C-Reactive Protein). ACR20 response requires: ① ≥20% improvement in TJC; ② ≥20% improvement in SJC; ③ ≥20% improvement in 3 of following 5 indicators: VAS, PGA, EGA, HAQ-DI, Acute-Phase Reactant (ESR or CRP).
7 secondary outcomes
ACR20 response rate at 4 and 12 weeks
Time frame: 4 and 12 weeks after enrollment
ACR50 response rates at 4, 12, and 24 weeks
Time frame: 4, 12, and 24 weeks after enrollment
ACR70 response rates at 4, 12, and 24 weeks
Time frame: 4, 12, and 24 weeks after enrollment
Improvement in DAS28 scores at 4, 12, and 24 weeks compared to baseline.
Time frame: 4, 12, and 24 weeks after enrollment compared to baseline
Improvement in CDAI scores at 4, 12, and 24 weeks compared to baseline
Time frame: 4, 12, and 24 weeks after enrollment compared to baseline
Improvement in patient global assessment (PGA), Visual Analog Score for pain (VAS), and evaluator global assessment (EGA) at 4, 12, and 24 weeks compared to baseline.
Time frame: 4, 12, and 24 weeks after enrollment compared to baseline
Safety endpoints within 24 weeks, including the number and incidence of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs).
Time frame: 4, 12, and 24 weeks after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Rheumatoid Arthritis (RA)
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
Recruiting
GenAI-Assisted Rheumatoid Arthritis Bone Erosion Risk Assessment and DMARD Selection
Rheumatoid Arthritis
Not yet recruitingObservational study
The Impact of Rheumatoid Arthritis Treatments on the Modulation of Extracellular Vesicles and Other Biomarkers Involved in the Development of Lung Cancer
Rheumatoid Arthritis (RA), Lung Neoplasms
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
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.
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 (RA), run by Peking University People's Hospital 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 11 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 11 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact XU LIU, MD (010-88325223, liuxupkupku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR20 response rate at 24 weeks (time frame: 24 weeks after enrollment). 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 11 Mar 2026.