To investigate weather the concentration of baseline serum cytokines can become the predictor of treatment response of tocilizimab.

To investigate weather the concentration of baseline serum cytokines can become the predictor of treatment response of tocilizimab. - PREDICT-TCZ study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000010647

Enrollment

Registered

2013-05-04

Start date

2013-04-01

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)Patients between 20 and 90 years old 2)Patients with rheumatoid arthritis 3)Patients with low to moderate activity 4)Patient is going to give tocilizumab 5)The patient by whom consent is got in written form about participation of the final examination

Exclusion criteria

Exclusion criteria: 1)Patients who have serious infection 2)Patients who have history of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies 3)Patients who have history of a malignant tumor or who have malignant tumor 4)Patients who have serious cardiac disease or liver disease, renal damage 5)Pregnant women or women trying to get pregnant 6)Patients considered inappropriate judged by attending physicians

Design outcomes

Primary

Measure	Time frame
Correlation between the concentration of various kinds of serum cytokine at 24 weeks and CDAI at 24 weeks	—

Secondary

Measure	Time frame
1.Correlation between the concentration of various kinds of serum cytokine and clinical remission assessed by CDAI at 24 weeks 2.Correlation between the concentration of various kinds of serum cytokine and the joints damage at 52 weeks 3.Change of DAS28ESR(4),CDAI and Simplified Disease Activity Score(SDAI) from baseline for every 4 weeks Remission rate assessed by SDAI,CDAI,DAS28ESR(4) and ACR/EULAR Boolean based criteria 4.Any adverse events	—

Measure

Time frame

1.Correlation between the concentration of various kinds of serum cytokine and clinical remission assessed by CDAI at 24 weeks 2.Correlation between the concentration of various kinds of serum cytokine and the joints damage at 52 weeks 3.Change of DAS28ESR(4),CDAI and Simplified Disease Activity Score(SDAI) from baseline for every 4 weeks Remission rate assessed by SDAI,CDAI,DAS28ESR(4) and ACR/EULAR Boolean based criteria 4.Any adverse events

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Countries

Japan

Outcome results