Relationship between treatment response of initial DMARD and outcome of treat-to-target strategy in patients with early rheumatoid arthritis: Nationwide Inception Cohort of Early Rheumatoid arthritis patients in Japan

Relationship between treatment response of initial DMARD and outcome of treat-to-target strategy in patients with early rheumatoid arthritis: Nationwide Inception Cohort of Early Rheumatoid arthritis patients in Japan - NICER-J

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000031950

Enrollment

685

Registered

2018-04-01

Start date

2018-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 1987 Classification criteria of American College of Rheumatology or 2010 American Rheumatology Association / European Rheumatology Association (ACR / EULAR) classification criteria are met. 2) Patients diagnosed within 6 months of RA who are not undergoing DMARD treatment or within 3 months 3) Patients who are over 20 years of age at the time of consent acquisition 4) Patients who received written explanations about the purpose and contents of this study, and obtained consent form freely by the person himself / herself in writing

Exclusion criteria

Exclusion criteria: 1) Patients who have been treated with MTX exceeding 6 mg or who have been treated 2) Patients who are being treated with biologic drugs or targeted synthetic antirheumatic drugs or who have been treated 3) Patients who can not comply with dosage regimen 4) Patients who are deemed inappropriate for research by the research staff

Design outcomes

Primary

Measure	Time frame
1.To explore relationship between the changes in disease activity by csDMARD treatment and that of disease activity up to 24 weeks for the first adapting therapy (bDMARD / tsDMARD, or csDMARD). Also analyze by each adapting therapy. 2.To identify factors related to achieving remission at week 24. Also analyze by each adapting therapy.	—

Secondary

Measure	Time frame
1) To explore the relationship between the changes in disease activity by initial treatment after registration and the transition of disease activity up to 52 weeks after first adapting therapy, also for each adapting therapy 2) Factors related to achieving remission at 52 weeks after first adapting therapy, also for each adapting therapy 3) In the cases where MTX was started or increased as the initial treatment after registration, the relationship between the changes in disease activity by MTX treatment and that of the disease activity up to the 24 week and the 52 week after first adapting therapy, also for each adapting therapy 4) In case of starting or increasing MTX as the initial treatment after enrollment, analyze also for each factor relating to remission achievement at 24 and 52 weeks after first adapting therapy, also for each adapting therapy 5) Comparison of the changes in disease activity during adapting therapy between the groups which could and could not start treatment with MT 6) Trends of the following factors and relationship among factors in postmenopausal women: disease activity, biomarkers at the start of treatment (anti-CCP antibody, inflammatory cytokine, bone metabolism marker, cartilage metabolism marker), total Sharp score (Limb bone joint destruction), narrowing of knee joint joint space, DEXA 7) Content and outcome of serious adverse events occurring during observation	—

Measure

Time frame

1) To explore the relationship between the changes in disease activity by initial treatment after registration and the transition of disease activity up to 52 weeks after first adapting therapy, also for each adapting therapy 2) Factors related to achieving remission at 52 weeks after first adapting therapy, also for each adapting therapy 3) In the cases where MTX was started or increased as the initial treatment after registration, the relationship between the changes in disease activity by MTX treatment and that of the disease activity up to the 24 week and the 52 week after first adapting therapy, also for each adapting therapy 4) In case of starting or increasing MTX as the initial treatment after enrollment, analyze also for each factor relating to remission achievement at 24 and 52 weeks after first adapting therapy, also for each adapting therapy 5) Comparison of the changes in disease activity during adapting therapy between the groups which could and could not start treatment with MT 6) Trends of the following factors and relationship among factors in postmenopausal women: disease activity, biomarkers at the start of treatment (anti-CCP antibody, inflammatory cytokine, bone metabolism marker, cartilage metabolism marker), total Sharp score (Limb bone joint destruction), narrowing of knee joint joint space, DEXA 7) Content and outcome of serious adverse events occurring during observation

—

Countries

Japan

Contacts

Public ContactShuji Asai

Nagoya University Hospital Center for Advanced Medicine and Clinical Research

asai@med.nagoya-u.ac.jp052-744-1908

Outcome results