Predictive factors for the safe reduction of Methotrexate in the patients of rheumatoid arthritis under the golimumab treatment

Predictive factors for the safe reduction of Methotrexate in the patients of rheumatoid arthritis under the golimumab treatment - Predictive factors for the safe reduction of Methotrexate in the patients of rheumatoid arthritis under the golimumab treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038817

Enrollment

458

Registered

2019-12-10

Start date

2019-12-11

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: Patients who is 20 years of age or more when obtaining consent. Patients who were diagnosed as RA. Patients who had over 6 months of the treatment history of 50 mg GLM + MTX and have collectable medical record. (The patients who were prescribed GLM and MTX more than one month, even reducing MTX to 0 mg after the period.)

Exclusion criteria

Exclusion criteria: The patients who had treated with 100mg GLM. The patients who have washout periods of GLM over twelve weeks. (To exclude the patients who have the possibility of treatment of other bDMARDs during washout periods) The patients who reduced the MTX dose but increased up to previous dose due to managing conditions. The patients who do not have the information about the disease activity (DAS28CRP) at baseline. The patients who refuted to join the study. The patients whom the researchers considered should not be included to the study.

Design outcomes

Primary

Measure	Time frame
The predictors for the safe reduction of Methotrexate in the patients of rheumatoid arthritis under the golimumab treatment. (Following factors from patient's demographics would be investigated: sex, age, weight, duration of illness, the information of pretreatment drugs (NSAIDs, steroids, DMARDs, bDMARDs etc.) administration periods of the pretreatment drugs, DAS28, CRP, ESR, anti-CCP antibodies, RF, SDAI, CDAI, HAQ-DI) dose of MTX, complications. etc.)	—

Measure

Time frame

The predictors for the safe reduction of Methotrexate in the patients of rheumatoid arthritis under the golimumab treatment. (Following factors from patient's demographics would be investigated: sex, age, weight, duration of illness, the information of pretreatment drugs (NSAIDs, steroids, DMARDs, bDMARDs etc.) administration periods of the pretreatment drugs, DAS28, CRP, ESR, anti-CCP antibodies, RF, SDAI, CDAI, HAQ-DI) dose of MTX, complications. etc.)

—

Secondary

Measure	Time frame
The characteristics of the patients who decreased MTX under the GLM treatment. Evaluation of the disease activities of MTX-reduction group and MTX-non-reduction group. (DAS28CRP comparison data of 3M, 6M, 12M)	—

Countries

Japan

Contacts

Public ContactMasami Takei

Nihon University School of Medicine Division of Hematology and Rheumatology

takei.masami@nihon-u.ac.jp03-3972-8111

Outcome results