ICTRP Search Portal

Main

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:	17 October 2023
Main ID:	JPRN-UMIN000021492
Date of registration:	20/03/2016
Prospective Registration:	No
Primary sponsor:	Inoue Hospital
Public title:	To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients.
Scientific title:	To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients. - Switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.
Date of first enrolment:	2016/03/01
Target sample size:	40
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024788
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Makoto Inoue
Address:	55 Tohrimachi,Takasaki city, Gunma 370-0053,Japan Japan
Telephone:	027-322-3660
Email:	m2inoue@marianna-u.ac.jp
Affiliation:	Inoue Hospital Dpepartment of Rheumatology

Name:	Makoto Inoue
Address:	55 Tohrimachi,Takasaki city, Gunma 370-0053,Japan Japan
Telephone:	027-322-3660
Email:	m2inoue@marianna-u.ac.jp
Affiliation:	Inoue Hospital Dpepartment of Rheumatology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1.Patients who corresponds to a contraindication of infliximab of infliximab biosimilar 1 2.Patients their doctors find not appropriate for this study

Age minimum: 18years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis

Intervention(s)

switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.

Primary Outcome(s)

Change in safety and efficacy before and after switch prescripution.

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Inoue Hospital

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	31/07/2017
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.