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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:	ChiCTR
Last refreshed on:	18 June 2018
Main ID:	ChiCTR1800016629
Date of registration:	2018-06-14
Prospective Registration:	No
Primary sponsor:	Ren Ji Hospital South Campus, Shanghai Jiaotong University School of Medicine
Public title:	An observation of tofacitinib in patients of MDA5+ clinically amyopathic dermatomyositis with interstitial lung disease
Scientific title:	An observation of tofacitinib in patients of MDA5+ clinically amyopathic dermatomyositis with interstitial lung disease
Date of first enrolment:	2017-07-01
Target sample size:	study group:15;control group:35;
Recruitment status:	Recruiting
URL:	http://www.chictr.org.cn/showproj.aspx?proj=27665
Study type:	Observational study
Study design:	Historical control
Phase:	Post-market

Countries of recruitment
China

Contacts

Name:	Chen Zhiwei
Address:	2000 Jiangyue Road, Shanghai, China
Telephone:	+86 13621621736
Email:	czw517779497@sina.com
Affiliation:	Ren Ji Hospital South Campus, Shanghai Jiaotong University School of Medicine

Name:	Wang Xiaodong
Address:	2000 Jiangyue Road, Shanghai, China
Telephone:	+86 13564082765
Email:	wangxiaodong@renji.com
Affiliation:	Ren Ji Hospital South Campus, Shanghai Jiaotong University School of Medicine

Key inclusion & exclusion criteria

Inclusion criteria: 1. aged >18 years;
2. the patient or family members signed the informed consent voluntarily;
3. agreed to adopt effective contraceptive measures during the study period (child-bearing women);
4. MDA5 antibody positive;
5. disease duration of ILD less than 3 months;
6. impaired pulmonary function, while FVC=50%.
Exclusion criteria: 1. merge with other connective tissue diseases or tumor;
2. patients with severe liver damage (liver enzyme > 2 times upper limit of normal;
3. patients are reluctant to sign the informed consent.

Age minimum: 18
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

dermatomyositis

Intervention(s)

study group:tofacitinib;control group:glucocorticoids+immunosuppressant;

Primary Outcome(s)

;survival of 12 months;

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

self-collected funds

Secondary Sponsor(s)

Ethics review

Status: Not approved
Approval date: 26/08/2013
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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