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
1 other identifier
observational
664
1 country
7
Brief Summary
This study is to evaluate the safety and the effectiveness of treatment with tacrolimus and biological agents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2012
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 4, 2013
CompletedFirst Posted
Study publicly available on registry
June 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedOctober 5, 2015
October 1, 2015
2.6 years
June 4, 2013
October 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Simplified disease activity index (SDAI)
Baseline and week-24
Secondary Outcomes (2)
Clinical disease activity index (CDAI)
Baseline, week-12 and week-24
Disease Activity Score 28 (DAS28)
Baseline, week-12 and week-24
Study Arms (1)
tacrolimus + biological agents
Interventions
Eligibility Criteria
Patients with rheumatoid arthritis who have been treated with biological agents
You may qualify if:
- patients with rheumatoid arthritis who have been treated with biological agents over 8 weeks but have not achieved SDAI remission (SDAI \< 3.3)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Chūbu, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kantou, Japan
Unknown Facility
Kyushu, Japan
Unknown Facility
Shikoku, Japan
Unknown Facility
Tōhoku, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2013
First Posted
June 6, 2013
Study Start
August 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
October 5, 2015
Record last verified: 2015-10