Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILD

Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Study ID
NCT01862926
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Idiopathic Inflammatory Myositis
  • Interstitial Lung Disease
  • Mixed Connective Tissue Disease
  • Scleroderma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Interstitial lung disease (ILD) is characterised by inflammation and scarring of the lung and is the leading cause of death in patients with systemic sclerosis, and contributes significantly to morbidity and mortality in many other connective tissue diseases (CTDs) such as polymyositis/dermatomyositis and mixed connective tissue disease. When ILD is extensive and/or progressive, immunosuppressive medication is often required to stabilize lung disease and alleviate symptoms. Current standard care for CTD associated ILD is extrapolated from studies performed in individuals with systemic sclerosis and comprises low dose corticosteroids and intravenous cyclophosphamide followed by oral azathioprine. In some individuals even this intensive immunosuppression is insufficient to prevent deterioration, and in a significant minority of affected individuals this results in respiratory failure and death. Rituximab has recently been reported as an effective 'rescue therapy' for stabilizing and even improving ILD in this patient group. Based on observations gained from this experience, the investigators believe that rituximab is a potential important alternative to current best therapy for this patient group. This study has therefore been initiated to evaluate the efficacy of rituximab (compared with standard therapy) in patients with progressive CTD related ILD.

Key Dates

Start date
Nov 30, 2014
Status verified
Oct 2021
Primary completion
Jan 31, 2021
Completion
Jan 31, 2021

Study Design

Enrollment
104 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    1g given at baseline and two weeks.
  • Active Comparator: Cyclophosphamide
    Intravenous dose of 600 mg/m2 body surface area. 6 doses given 4 weekly.

Primary Outcome Measure

Absolute change in FVC [ Time Frame: 48 weeks ]

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