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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:	17 October 2023
Main ID:	JPRN-UMIN000007671
Date of registration:	09/04/2012
Prospective Registration:	No
Primary sponsor:	Department of Neurology, Chiba University Graduate School of Medicine
Public title:	Randomized comparative study on efficacy and safety of reduced-dose steroid combined with tacrolimus vs conventional-dose steroid in late- or elderly-onset myasthenia gravis patients
Scientific title:	Randomized comparative study on efficacy and safety of reduced-dose steroid combined with tacrolimus vs conventional-dose steroid in late- or elderly-onset myasthenia gravis patients - Steroid combined with tacrolimus for late- or elderly-onset patients of myasthenia gravis (STEP-MG)
Date of first enrolment:	2012/04/01
Target sample size:	40
Recruitment status:	Recruiting
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009037
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not applicable

Countries of recruitment
Japan

Contacts

Name:
Address:	1-8-1 Inohana, Chuo-ku, Chiba Japan
Telephone:
Email:
Affiliation:	Chiba University Graduate School of Medicine Department of Neurology

Name:	Akiyuki Uzawa
Address:	1-8-1 Inohana, Chuo-ku, Chiba Japan
Telephone:
Email:
Affiliation:	Chiba University Graduate School of Medicine Department of Neurology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: Patients disqualified by doctor in attendance with any reason

Age minimum: 50years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Myasthenia gravis

Intervention(s)

Administration of prednisolone 35 mg/day with tacrolimus 3mg a day
Administration of prednisolone 50 mg/day

Primary Outcome(s)

Percentage of the patients taking prednisolone less than 5mg/day and maintaining with Minimal Manifestations after 2 years

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Chiba University

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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