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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-UMIN000009887
Date of registration: 01/04/2013
Prospective Registration: Yes
Primary sponsor: Department of Orthopaedic surgery, Tohoku University Hospital
Public title: Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6
Scientific title:
Date of first enrolment: 2013/04/01
Target sample size: 100
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011514
Study type:  Interventional
Study design:  Parallel Non-randomized  
Phase:  Not applicable
Countries of recruitment
Japan
Contacts
Name: Hiroshi Okuno   
Address:  Japan
Telephone: 022-717-7245
Email: okuno@med.tohoku.ac.jp
Affiliation:  Tohoku University Hospital Orthopaedic surgery
Name: Hiroshi Okuno   
Address:  1-1 Seiryo-machi, Aoba-ku, Sendai, JAPAN Japan
Telephone: 022-717-7245
Email:
Affiliation:  Tohoku University Hospital Department of Orthopaedic surgery
Key inclusion & exclusion criteria
Inclusion criteria: 1. Patients with more than 20 years at the time of informed consent
2. Patients with oral methotrexate
3. Patients with informed consent

Exclusion criteria: 1. Patients with severe infectious disease
2. Patients with active tuberculosis
3. Patients with allergy to infliximab or mouse protein
4. Patients with demyelinated disease
5. Patients with congestive heart failure


Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha.
If the initial concentration of serum TNF alpha is less than 1.1 pg/ml, we will raise the dose of infliximab to 6 mg/kg.
When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha.
If the initial concentration of serum TNF alpha is more than 1.1 pg/ml, we will raise the dose of infliximab to 10 mg/kg.
Primary Outcome(s)
Disease Activity Score-28 (DAS28-CRP/ESR)
Simplified Disease Activity Index (SDAI)
Clinical Disease Activity Index (CDAI)
Secondary Outcome(s)
Van der Heijde' modified Sharp score
Secondary ID(s)
Source(s) of Monetary Support
research fund of Orthopaedic surgery in Tohoku University Hospital
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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