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Pirfenidone in Progressive Interstitial Lung Disease Associated With Clinically Amyopathic Dermatomyositis

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ClinicalTrials.gov Identifier: NCT02821689
Recruitment Status : Unknown
Verified June 2016 by Shuang Ye, RenJi Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Shuang Ye, RenJi Hospital

Brief Summary:

Interstitial lung disease (ILD) is a common complication of dermatomyositis (DM) with prevalence up to 65%, and is considered to be one of the determining factors of prognosis. Clinical amyopathic dermatomyositis (CADM), which is a special phenotype of DM, with characteristic cutaneous manifestations but no or only subclinical myopathy. Many studies, mainly from Asia, including ours, have demonstrated that these patients with CADM tend to develop a rapidly progressive ILD (RPILD) and have a poor response to conventional therapy, such as high-dose corticosteroids and immunosuppressants, leading to lethal outcome with a 6-month survival rate of less than 50%.

Pirfenidone, a new oral antifibrotic agent, has been approved for the treatment of idiopathic pulmonary fibrosis (IPF). Randomized controlled trials of pirfenidone in patients with IPF suggested that it could ameliorate pulmonary function decline and improve the progression-free survival. Its utility in connective tissue disease (CTD) related ILD has been implicated, but no evidence has yet demonstrated its efficacy. Therefore, the investigators conduct this study to evaluate the possible therapeutic effects of pirfenidone on RPILD associated with CADM.


Condition or disease Intervention/treatment Phase
Dermatopolymyositis Interstitial Lung Disease Drug: Pirfenidone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Pirfenidone in Patients With Progressive Interstitial Lung Disease Associated With Clinically Amyopathic Dermatomyositis
Study Start Date : July 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018


Arm Intervention/treatment
Experimental: pirfenidone
Eligible participants for clinical trial were randomized in a 2:1 ratio to pirfenidone/blank add-on. Pirfenidone was administered in three divided doses (200mg tid), and increased to the manufacturer's instructed target dose (600mg tid) over a 2-week period. Investigators were allowed to adjust the dose according to the participants' tolerance.
Drug: Pirfenidone
Pirfenidone was administered in three divided doses (200mg tid), and increased to the manufacturer's instructed target dose (600mg tid) over a 2-week period. The maximum dose was maintained throughout the study in patients who tolerated it.

No Intervention: Blank
Eligible participants for clinical trial were randomized in a 2:1 ratio to pirfenidone/blank add-on.



Primary Outcome Measures :
  1. changes of 12-month survival from the onset of ILD [ Time Frame: 12 months ]
    the effect of pirfenidone on improving the survival rate


Secondary Outcome Measures :
  1. changes of high-resolution computed tomography (HRCT) scores from baseline at each visit [ Time Frame: one year ]
    the influence of pirfenidone on pulmonary interstitial changes

  2. changes of pulmonary function test from baseline at each visit [ Time Frame: one year ]
    the influence of pirfenidone on pulmonary function changes



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willingness of the subject to participate in the study, proven by signing the informed consent;
  • All participants fulfilled the provisional diagnosis of CADM according to the modified Sontheimer's criteria.
  • The course of ILD is longer than 3 months, but shorter than 6 months, presenting as increase in level of dyspnea, and worsening of fibrosis on pulmonary HRCT with >10% increase of HRCT score, and/or decrease in %FVC by >10% absolute value.

Exclusion Criteria:

  • Participants who are unwilling to sign the inform consent;
  • The course of participants ever treated with biologics including basiliximab, or malignancy-associated CADM or overlapped with other CTD, or with alanine transaminase more than 2 times the upper normal limits;
  • Pregnancy or lactation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821689


Contacts
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Contact: Shuang Ye, MD +8613817615871 ye_shuang2000@163.com
Contact: Zhiwei Chen, MS +8613621621736 zwchen88@gmail.com

Locations
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China, Shanghai
Department of Rheumatology, Ren Ji Hospital South Campus, School of Medicine, Shanghai JiaoTong University Not yet recruiting
Shanghai, Shanghai, China, 200001
Sponsors and Collaborators
RenJi Hospital
Investigators
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Principal Investigator: Shuang Ye, MD RenJi Hospital

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Responsible Party: Shuang Ye, Executive Director, Dept. Rheumatology, Renji Hospital South Campus, RenJi Hospital
ClinicalTrials.gov Identifier: NCT02821689     History of Changes
Other Study ID Numbers: RenJi-ADM
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shuang Ye, RenJi Hospital:
Dermatopolymyositis
Interstitial lung disease
Pirfenidone

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Dermatomyositis
Respiratory Tract Diseases
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases
Pirfenidone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents