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Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung Disease (MYILD)

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ClinicalTrials.gov Identifier: NCT02896205
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
GSRSNK NAIDU, Postgraduate Institute of Medical Education and Research

Tracking Information
First Submitted Date  ICMJE August 27, 2016
First Posted Date  ICMJE September 12, 2016
Last Update Posted Date June 6, 2018
Study Start Date  ICMJE October 2016
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2016)
Change from baseline in Forced vital capacity (FVC) at 6 months, after treatment with oral mycophenolate mofetil or placebo [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02896205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2016)
  • Change from baseline in Quality of Life (QoL) score by Medical Outcome Short Form 36 (SF-36v2) at 6 months [ Time Frame: 6 months ]
  • Change from baseline in Mahler Dyspnoea Index (MDI) at 6 months [ Time Frame: 6 months ]
  • Number of participants with serious and non seroius adverse events with mycophenolate mofetil (MMF) and placebo [ Time Frame: 6 months ]
  • Change in Forced Vital Capacity (FVC) from baseline to 6 months according to antibody (anti-centromere and anti-topoisomerase1) profile [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung Disease
Official Title  ICMJE A Randomized Controlled Trial to Compare the Efficacy of Oral Mycophenolate Mofetil With Placebo in Patients With Systemic Sclerosis Related Early Interstitial Lung Disease
Brief Summary Systemic sclerosis is a multisystem disease and can involve the lungs in the form of ILD. Lung involvement is the most common cause of death in these patients. The present study is performed to study the efficacy of oral mycophenolate mofetil in treating early and mild ILD in patients of SSc. The efficacy and side effects of mycophenolate mofetil will be compared with that of oral placebo.
Detailed Description Lung involvement is the leading cause of death among patients with systemic sclerosis (SSc). Treatment with immunosuppression drugs helps in retarding the progression of interstitial lung disease (ILD) and improves the morbidity and mortality among these patients. Presently, cyclophosphamide has been shown to be useful in stabilizing the lung functions among patients of systemic sclerosis with ILD. But use of cyclophosphamide is also associated with many adverse effects including infections, cytopenias, gonadal dysfunction and malignancies. Use of oral mycophenolate mofetil (MMF) in SSc-ILD in recent studies has been shown to be effective in retarding progression of ILD among these patients with a better side effect profile compared to cyclophosphamide. Contemporary expert opinion dictates that the treatment for SSc-ILD needs to be individualized. Generally, intense immunosuppression is required in patients with FVC <70% of the predicted. In patients with FVC >70% of the predicted, the need for high dose immunosuppression is not clear and varies from center-to-center. The present study is designed to determine the efficacy of oral MMF in patients with SSc related early ILD. The subjects in this study will be given either oral MMF or placebo and will be monitored for their response and adverse events. Informed consent will be taken from the subjects before including in the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Systemic Sclerosis
  • Scleroderma
  • Interstitial Lung Disease
Intervention  ICMJE
  • Drug: Mycophenolate mofetil
    Subjects will be given oral Mycophenolate Mofetil starting at 500mg twice a day and increased gradually to a target dose of 2gram per day for 6 months
    Other Name: MMF
  • Drug: Placebo
    Subjects will be given matching placebo for 6 months
Study Arms  ICMJE
  • Experimental: Mycophenolate mofetil
    Subjects will be started on Mycophenolate Mofetil 500mg twice a day and increased by 500mg every 2 weeks, if tolerated, to a target dose of 2gram per day.
    Intervention: Drug: Mycophenolate mofetil
  • Placebo Comparator: Placebo
    Subjects in this arm will be given matching placebo, made of lactulose, starting at two tablets per day and increased by one tablet every 2 weeks to a target of 4 tablets per day.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2018)
41
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2016)
60
Actual Study Completion Date  ICMJE July 1, 2017
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients of systemic sclerosis with presence of interstitial lung disease on High Resolution Computer Tomography (HRCT) chest
  2. FVC ≥ 70% of predicted on pulmonary function tests
  3. Age ≥18 years
  4. Consenting for participating in study

Exclusion Criteria:

  1. Received immunosuppression (except low dose steroids, prednisolone equivalent ≤10 mg/day) for ILD in the last 3 years
  2. Persistent leucopenia or thrombocytopenia
  3. Pregnant or breastfeeding females
  4. Severe pulmonary arterial hypertension (mean pulmonary arterial pressure >55mmHg) requiring drug therapy
  5. Uncontrolled congestive heart failure
  6. Any other abnormalities noted on chest X-ray or HRCT other than ILD
  7. Active infection
  8. Inflammatory myositis
  9. Overlap syndrome
  10. Mixed connective tissue disease
  11. Other serious co-morbidities which could compromise patient's ability to complete the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02896205
Other Study ID Numbers  ICMJE NK/2612/DM/10772
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GSRSNK NAIDU, Postgraduate Institute of Medical Education and Research
Study Sponsor  ICMJE Postgraduate Institute of Medical Education and Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: GSRSNK Naidu, MD Post Graduate Institute of Medical Education and Research
PRS Account Postgraduate Institute of Medical Education and Research
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP