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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

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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Scleroderma Interstitial Lung Disease Drug: Mycophenolate mofetil Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Compare the Efficacy of Oral Mycophenolate Mofetil With Placebo in Patients With Systemic Sclerosis Related Early Interstitial Lung Disease
Study Start Date : October 2016
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017


Arm Intervention/treatment
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.
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

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.
Drug: Placebo
Subjects will be given matching placebo for 6 months




Primary Outcome Measures :
  1. Change from baseline in Forced vital capacity (FVC) at 6 months, after treatment with oral mycophenolate mofetil or placebo [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from baseline in Quality of Life (QoL) score by Medical Outcome Short Form 36 (SF-36v2) at 6 months [ Time Frame: 6 months ]
  2. Change from baseline in Mahler Dyspnoea Index (MDI) at 6 months [ Time Frame: 6 months ]
  3. Number of participants with serious and non seroius adverse events with mycophenolate mofetil (MMF) and placebo [ Time Frame: 6 months ]
  4. Change in Forced Vital Capacity (FVC) from baseline to 6 months according to antibody (anti-centromere and anti-topoisomerase1) profile [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02896205


Locations
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India
PGIMER
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: GSRSNK Naidu, MD Post Graduate Institute of Medical Education and Research

Publications:

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Responsible Party: GSRSNK NAIDU, SENIOR RESIDENT, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02896205     History of Changes
Other Study ID Numbers: NK/2612/DM/10772
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Sclerosis
Lung Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases
Connective Tissue Diseases
Skin Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action