UMIN ID: UMIN000002110
Registered date:23/06/2009
Discontinuation of infliximab therapy after acquisition of low disease activity by infliximab in rheumatoid arthritis study: RRR (remission induction by remicade) study
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | rheumatoid arthritis |
| Date of first enrollment | 2006/07/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | After discontinuing infliximab, 1. DAS28 (ESR) remains <3.2 for 1 year, 2. Yearly progression of van der Heijde-modified total Sharp score (TSS) remains <0.5 for 1 year. |
|---|---|
| Secondary Outcome | After discontinuing infliximab, 1. DAS28 (ESR) remains <3.2 for 2 year, 2. Yearly progression of van der Heijde-modified total Sharp score (TSS) remains <0.5 for 2 year. |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients who met the following criteria are excluded. 1) patients who are already in remission and do not use infliximab 2) control with less than 5mg/day of PSL 3) PSL was increased within 4 weeks before the study 4) patients who are not appropriate to the study by a doctor's judgement |
Related Information
| Primary Sponsor | University of Occupational & Environmental Health, Japan |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | a Research Grant-In-Aid for Scientific Research from the Ministry of Health, Labor and Welfare of Japan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazuyoshi Saito |
| Address | 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, 807-8555, Japan Japan |
| Telephone | 093-603-1611 |
| tanaka@med.uoeh-u.ac.jp | |
| Affiliation | School of Medicine, University of Occupational and Environmental Health, Japan First Department of Internal Medicine |
| scientific contact | |
| Name | Yoshiya Tanaka |
| Address | 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, 807-8555, Japan Japan |
| Telephone | 093-603-1611 |
| tanaka@med.uoeh-u.ac.jp | |
| Affiliation | School of Medicine, University of Occupational and Environmental Health, Japan First Department of Internal Medicine |