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CTRI Number  CTRI/2018/01/011449 [Registered on: 19/01/2018] Trial Registered Prospectively
Last Modified On: 12/11/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   to study the efficacy of pirfenidone in systemic sclerosis related interstitial lung disease 
Scientific Title of Study   A randomized controlled trial to compare the efficacy of pirfenidone with placebo in systemic sclerosis related interstitial lung disease 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nupoor Acharya 
Designation  Senior resident 
Affiliation  PGIMER 
Address  department of internal medicine, [PGIMER, sector 12, chandigarh
sector 12, chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  8130966761  
Fax    
Email  nupooracharya88@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  shefali khanna sharma 
Designation  additional professor 
Affiliation  PGIMER 
Address  department of internal medicine, [PGIMER, sector 12, chandigarh
sector 12, chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  9417372439  
Fax    
Email  sharmashefali@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Nupoor Acharya 
Designation  Senior resident 
Affiliation  PGIMER 
Address  department of internal medicine, [PGIMER, sector 12, chandigarh
sector 12, chandigarh, 160012
Chandigarh
CHANDIGARH
160012
India 
Phone  8130966761  
Fax    
Email  nupooracharya88@gmail.com  
 
Source of Monetary or Material Support  
drug is provided by Cipla 
 
Primary Sponsor
Modification(s)  
Name  Post graduate institute of medical education and research 
Address  PGIMER, sector -12,chandigarh 160012  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nupoor Acharya  PGIMER  department of internal medicine, sector 12
Chandigarh
CHANDIGARH 
8130966761

nupooracharya88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  systemic sclerosis with interstitial lung disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  pirfenidone  one tablet thrice a day (600 mg/day). The dose will be increased to 2 tablets thrice a day (1200 mg/day) after 1 week of initiating treatment, 3 tablets thrice a day (1800 mg/day) after 2 weeks & 4 tablets thrice a day (2400 mg/day) after 3 weeks & will be continued at 2400 mg/day till the end of the study i.e. 6 months. 
Comparator Agent  placebo  start with one tablet thrice a day (600 mg/day). The dose will be increased to 2 tablets thrice a day (1200 mg/day) after 1 week of initiating treatment, 3 tablets thrice a day (1800 mg/day) after 2 weeks & 4 tablets thrice a day (2400 mg/day) after 3 weeks & will be continued at 2400 mg/day till the end of the study i.e. 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients with SSc as diagnosed by the American College of
Rheumatology (ACR) criteria, 2013 & patients with other connective tissue diseases
who, in parallel, meet the ACR criteria for SSc
2. Presence of ILD on HRCT chest
3. FVC ≥ 50%
4. Duration of SSc for ≤7 years, with onset defined as the appearance of the first nonRaynaud’s
phenomenon.
5. DLCO 30% to 89% of predicted normal
6. Consenting for participating in study
7. Received no new immunosuppression for last 6 months (on stable doses of
immunosuppressants like azathioprine, MMF, cyclophosphamide, methotrexate for > 6
months) 
 
ExclusionCriteria 
Details  Change in immunosuppressant drugs (except low dose steroids i.e. prednisolone
equivalent ≤10 mg/day) for ILD in the previous 6 months.
2. Received biologics in the past
3. Persistent leukopenia or thrombocytopenia
4. Pregnant or breastfeeding females
5. Severe PAH (mean pulmonary arterial pressure >55mmHg) requiring drug therapy
6. FEV1/FVC ratio ≤65%
7. Uncontrolled congestive heart failure
8. Any other abnormalities noted on chest X-ray or HRCT other than ILD
9. Active infection
10. Inflammatory myopathy
11. Mixed connective tissue disease
12. Smoking during last 6 months
13. Other serious co-morbidities which could compromise the patient’s ability to complete
the study
14. Abnormal liver function tests (AST/ALT> 3times, bilirubin >1.5) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess improvement, stabilisation or worsening of interstitial lung disease as
measured by change in FVC at 6 months after initiation of therapy with pirfenidone or
placebo. Improvement will be defined as improvement in FVC by more than 10%,
stabilisation defined as increase or decrease in FVC between 1-10% & worsening will
be defined as decline in FVC by more than 10%. 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the change in Modified Rodnan skin Score (mRSS) from baseline after 6
months of therapy with pirfenidone or placebo
2. To compare the improvement in 6MWT after 6 months of therapy with pirfenidone or
placebo.
3. To compare the change in Mahler’s transient dyspnea index (TDI/BDI) after 6 months
of therapy with pirfenidone or placebo.
4. To compare the change in the levels of TGF-β & TNF-α in the serum after 6 months of
therapy with pirfenidone or placebo. 
6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Brief Summary  

     The major life-threatening complications of scleroderma are renal crisis, interstitial lung disease (ILD), pulmonary arterial hypertension and cardiac involvement. With the use of ACE-inhibitors, cases of scleroderma renal crisis have considerably reduced. Presently a major cause of mortality in SSC is ILD. Despite improvement in medical therapy, the response in patients with ILD is not as much as expected. There are many unmet medical needs of patients of SSc ILD. SLS1 and SLS2 has shown some benefit with cyclophosphamide and MMF. But new therapies need to be explored. Pirfenidone is an antifibrotic and anti-inflammatory drug that acts mainly through TGF-β. It has shown to be beneficial in patients with IPF.There are no randomized trials comparing the efficacy of pirfenidone with placebo in systemic sclerosis associated ILD. The present study is undertaken to study the efficacy of pirfenidone in patients of SSc with ILD and to study the effects of these drugs on PFTs, HRCT changes, cytokines levels and also to observe the potential adverse effects of these drugs.

This will be a single center, prospective randomized , double blinded, controlled study. The study will

be carried out on 50 consecutive consenting patients of systemic sclerosis with ILD recruited from rheumatology clinic

of PGIMER Chandigarh, India, a tertiary care hospital.The duration of study will be 18 months.

Clinical details including the symptoms and clinical findings and laboratory parameters including haemogram, renal

function tests (RFT), liver function tests (LFT), urine routine and microscopic, PFTs, HRCT chest, ANA immunoblot and cytokines levels will be performed at initiation of therapy. Functional assessment will be done with 6 minute walk test (6MWT). The patients will be re-assessed on follow up at 3 and 6 months. The change in cytokines levels post therapy will also be assessed. The aim of the study is to assess improvement, stabilization or worsening of lung functions with pirfenidone. It will be correlated with the cytokines levels. Change in dyspnoea score using Mahler transitional dyspnoea index (TDI) will be assessed at 6 months

Randomization: The study consists of two treatment arms. In the pirfenidone arm, the patients will receive pirfenidone 800 mg three times a day for 6 months. In the placebo arm, patients will receive placebo for 6 months. A stratified randomization of the patients will be performed. The patients will be randomized in a 1:1 ratio by a computer generated randomization sequence into either pirfenidone or placebo arm. Allocation concealment will be ensured by using sealed opaque envelopes.

 
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