UMIN ID: UMIN000000512
Registered date:03/11/2006
Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Rheumatoid Arthritis |
| Date of first enrollment | 2006/10/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | If the score of DAS28 is under 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, doses of methotrexate will reduced to 2mg/w. When the score of DAS28 increses, tacrolimus will be administered instead of methotrexate. Period of observation is 32 weeks. If the score of DAS28 is over 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, tacrolimus will be administered. Period of observation is 32 weeks. |
Outcome(s)
| Primary Outcome | DAS28 |
|---|---|
| Secondary Outcome | ACR definition of improvement, CRP, Adverse events |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Dose of predonisone is over 5mg/day, patients who cannot receive tacrolimus |
Related Information
| Primary Sponsor | Rheumatosurgery, Osaka City University Medical School |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Tanabe Seiyaku Co. Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yuko Sugioka |
| Address | Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan Japan |
| Telephone | 06-6645-3851 |
| tatsuya@med.osaka-cu.ac.jp | |
| Affiliation | Osaka City University Medical School Orthopaedic Surgery |
| scientific contact | |
| Name | tatsuya Koike |
| Address | Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan Japan |
| Telephone | 06-6645-3851 |
| Affiliation | Osaka City University Medical School Rheumatosurgery |