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

Drug Use-result Survey to Assess the Safety and Efficacy of the Combination of Tacrolimus + Biological Agents in Daily Clinical Settings

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01870908

Enrollment

664

Registered

2013-06-06

Start date

2012-08-31

Completion date

2015-03-31

Last updated

2015-10-05

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

Conditions

Rheumatoid Arthritis

Brief summary

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

Detailed 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.

Interventions

DRUGtacrolimus

DRUGbiological agents

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Simplified disease activity index (SDAI)	Baseline and week-24

Secondary

Measure	Time frame
Clinical disease activity index (CDAI)	Baseline, week-12 and week-24
Disease Activity Score 28 (DAS28)	Baseline, week-12 and week-24

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026