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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870908
• Other study ID #: PRGR03
• Status: Completed
• Phase: N/A
• First received: June 4, 2013
• Last updated: October 2, 2015
• Start date: August 2012
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 664
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• tacrolimus

• biological agents

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simplified disease activity index (SDAI)		Baseline and week-24	No
Secondary	Clinical disease activity index (CDAI)		Baseline, week-12 and week-24	No
Secondary	Disease Activity Score 28 (DAS28)		Baseline, week-12 and week-24	No