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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: tacrolimus; Drug: biological agents

• Registration Number: NCT01870908
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-06
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-02
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 664

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
tacrolimus + biological agents	tacrolimus	-
tacrolimus + biological agents	biological agents	-

Primary Outcome Measures

Name	Time	Method
Simplified disease activity index (SDAI)	Baseline and week-24

Secondary Outcome Measures

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