Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients

Astellas Pharma Inc664 enrolled

Overview

This study is to evaluate the safety and the effectiveness of treatment with tacrolimus and biological agents.

The purpose of this study is to confirm the safety of 24 weeks-treatment with the combination of tacrolimus + biological agents, and to assess the efficacy using SDAI, CDAI, DAS28-CRP, MMP-3, MHAQ in patients with rheumatoid arthritis who have not achieved SDAI remission despite of using biological agents for over 8 weeks.

Study Type

OBSERVATIONAL

Enrollment

664

Conditions

Rheumatoid Arthritis

Interventions

tacrolimusDRUG

biological agentsDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * patients with rheumatoid arthritis who have been treated with biological agents over 8 weeks but have not achieved SDAI remission (SDAI \< 3.3)

Locations (7)

Unnamed facility

Chūbu, Japan

Unnamed facility

Hokkaido, Japan

Unnamed facility

Kansai, Japan

Unnamed facility

Kantou, Japan

Unnamed facility

Kyushu, Japan

Outcomes

Primary Outcomes

Simplified disease activity index (SDAI)

Time frame: Baseline and week-24

Secondary Outcomes

Clinical disease activity index (CDAI)

Time frame: Baseline, week-12 and week-24

Disease Activity Score 28 (DAS28)

Time frame: Baseline, week-12 and week-24

Data from ClinicalTrials.gov

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