Trials / Completed
CompletedNCT01870908
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 664 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tacrolimus | |
| DRUG | biological agents |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2013-06-06
- Last updated
- 2015-10-05
Locations
7 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01870908. Inclusion in this directory is not an endorsement.