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

Astellas

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: biological agents; Drug: tacrolimus

Study type: Observational

Funder types: Industry

Identifiers

NCT01870908

PRGR03

Details and patient eligibility

About

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

Full description

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.

Enrollment: 664 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

664 participants in 1 patient group

tacrolimus + biological agents

Treatment:

Drug: tacrolimus

Drug: biological agents