Rheumatoid arthritis
Conditions
Interventions
MTX subcutaneous injection group (cohort 1: Chinese patients with rheumatoid arthritis):Cohort 1 subjects received subcutaneous MTX
MTX subcutaneous injection group (cohort 2: Chinese patients with rheumatoid arthritis with interstitial lung diseases (ILDs) or interstitial lung abnormalities (ILA)):Cohort 2 subjects received subcu
MTX subcutaneous injection group (cohort 3: Chinese patients with rheumatoid arthritis of different clinical types):Cohort 3 subjects received subcutaneous MTX
MTX subcutaneous injection group (cohort 4: Chinese patients with rheumatoid arthritis and stable coronary artery disease (SCAD)):Cohort 4 subjects received subcutaneous MTX
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1: Diagnosed with rheumatoid arthritis, meeting the 1987 ACR classification criteria for RA or the 2010 ACR/EULAR classification criteria for RA 2: Those who are currently starting or planning to start subcutaneous methotrexate injection treatment and the expected benefits outweigh the risks, as assessed by the investigators 3: Agree to participate in this study, be able to cooperate with follow-up, and sign the informed consent form 4: Diagnosis of interstitial lung disease (ILDs) or interstitial lung abnormality (ILA) before or at enrollment [Cohort 2 only] 5: Baseline forced vital capacity (FVC) results are available at enrollment and are 50% or above of the predicted value [Cohort 2 only] 6: Have clear clinical classification results at the time of enrollment [Cohort 3 only] 7: Participants diagnosed with SCAD before or at enrollment, with CRP or high-sensitivity CRP (hsCRP) >= 2 mg/L, including participants with a history of coronary artery intervention or coronary artery bypass grafting for at least 1 year, or angiography showing >= 50% stenosis in at least one coronary artery and who do not require revascularization [Cohort 4 only]
Exclusion criteria
Exclusion criteria: 1: Pregnant or lactating women 2: Serum creatinine (Scr): Scr (female)>1.4 mg/dL (124 µmol/L); Scr (male)>1.6 mg/dL (141 µmol/L); ALT or AST > 1.5 times of the upper limit of normal (ULN) 3: Platelet count (PLT) 1.5 times of the upper limit of normal (ULN) 4: Participants with severe, poorly controlled concomitant diseases, such as (but not limited to) nervous system, cardiovascular, liver, kidney, gastrointestinal, and endocrine diseases, which the investigator judges may prevent the participants from participating in this study. 5: Participants with malignant tumors within 5 years 6: Heart disease: decompensated heart failure or refractory hypertension (hypertension that cannot control systolic and diastolic blood pressure to target levels after lifestyle modification and combined treatment with at least three antihypertensive drugs, including diuretics, in adequate doses and in a reasonable combination) 7: Participants with obvious or laboratory-confirmed immunodeficiency syndrome 8: Participants with serious acute or chronic infections 9: Participants with existing blood system damage, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or anemia 10: Participants who are allergic to relevant drugs used in this study 11: Those with a history of drug abuse, mental illness, or alcoholism who are unable to cooperate with investigators 12: Participants who the investigators consider unsuitable to participate in the study 13: For those combined with other lung lesions other than interstitial lung disease, the evaluation criteria are as follows: ? Those combined with moderate to severe pulmonary hypertension who require special treatment: evaluated by experts from the rheumatology and immunology departments of each center; ? Those with other clinical manifestations of severe lung lesions, such as lung tumors or active lung infection; ? Combined with other rheumatic and immune diseases (including but not limited to systemic lupus erythematosus, inflammatory myopathy, systemic sclerosis, primary biliary cirrhosis, etc.) [Cohort 2 only] 14: Participants who are currently receiving high-dose prednisone, azathioprine, N-acetylcysteine, or any investigational treatment for pulmonary fibrosis [Cohort 2 only] 15: Concomitant medication: Concomitant medications not permitted include: infliximab, adalimumab, etanercept, etc.) and/or Jak kinase inhibitors (including but not limited to tofacitinib, baricitinib), leflunomide. If rituximab, mycophenolate mofetil, cyclosporine, azathioprine, or cyclophosphamide are used, the dose must be stable for at least three months before enrollment [Cohort 2 only] 16: Participants with other lung diseases, such as lung infection, tuberculosis, chronic obstructive pulmonary disease, bronchiectasis and lung tumors [Cohort 2 only] 17: Excluding pneumoconiosis and interstitial pulmonary disease caused by inhalation of organic matter [Cohort 2 only] 18: Those with severe cardiopulmonary insufficiency [Cohort 2 only] 19: Participants who have experienced acute coronary syndrome within 1 year [Cohort 4 only] 20: Participants with poorly controlled hypertension, hyperlipidemia, and diabetes [Cohort 4 only] 21: Severe cardiovascular disease: persistent severe angina (CCS grade IV)/New York Heart Association functional class III-IV [Cohort 4 only]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average decline in forced vital capacity (FVC) after 1 year [Cohort 2];Number and proportion of various cardiovascular events in 2 years [Cohort 4];Improvement in CDAI score after 4 weeks, 12 weeks, and 24 weeks compared to baseline [Cohort 1, 3 and 4];ACR20 response rate after 24 weeks [Cohort 1 and 3];ACR20 response rate after 4 and 12 weeks [Cohort 1 and 3];ACR50, ACR70 response rate after 4 and 12 weeks [Cohort 1 and 3];ACR20/50/70 response rate after 4, 12 and 24 weeks [Cohort 4];Safety indicators within 24 weeks, including the number and incidence of adverse events (AEs), serious adverse events (SAEs), and adverse reactions (ADRs) [Cohort 1 to 4];Changes in chronic obstructive pulmonary disease score (CAT) after 4 weeks, 12 weeks, 24 weeks, and 1 year compared to baseline [Cohort 2];Improvement in DAS28 score after 4 weeks, 12 weeks, 24 weeks compared to baseline [Cohort 1 and 3];Compared with baseline, the patient's self-assessment (PGA), patient's pain (VAS), and physician's assessment of the patient's condition (EGA) improved after 4,12 and 24 weeks [Cohort 1, 3 and 4];Compared with baseline, the patient's self-assessment (PGA), patient's pain (VAS), and physician's assessment of the patient's condition (EGA) improved after 4,12 and 24 weeks [Cohort 2];Time to first acute exacerbation of interstitial lung disease in patients after 1 year [Cohort 2];Improvement in DAS28 score after 4 weeks, 12 weeks, 24 weeks and 1 year compared to baseline [Cohort 2];Improvement in CDAI score after 4 weeks, 12 weeks, 24 weeks and 1 year, compared to baseline [Cohort 1, 3 and 4]; | — |
Countries
China
Contacts
Public ContactLi Zhanguo
Peking University People's Hospital
Outcome results
None listed