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

October 2, 2015 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

664

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu, Japan
      • Hokkaido, Japan
      • Kansai, Japan
      • Kantou, Japan
      • Kyushu, Japan
      • Shikoku, Japan
      • Touhoku, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with rheumatoid arthritis who have been treated with biological agents

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
tacrolimus + biological agents
Drug: tacrolimus
Other Names:
  • prograf
Drug: biological agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Simplified disease activity index (SDAI)
Time Frame: Baseline and week-24
Baseline and week-24

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRGR03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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