CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 158 enrolled
Drug / intervention
Cyclophosphamide +1 moredrug
Likely dose
Cyclophosphamide 1 mg/kg/day initially, increased monthly by one capsule up to 2 mg/kg/dayAI-extracted
Key inclusion· 4
  • ✓Limited or diffuse systemic scleroderma with evidence of active alveolitis on BAL (neutrophilia ≥3% or eosinophilia ≥2%) and ground-glass opacity on CT
  • ✓Onset of first scleroderma symptom (other than Raynaud's) within 7 years
  • ✓Forced vital capacity (FVC) between 45 and 85% of predicted
  • ✓Grade 2 exertional dyspnea on Mahler Dyspnea Index
Key exclusion· 6
  • ✕Diffusing capacity (DlCO) <30% of predicted
  • ✕Smoking within preceding 6 months
  • ✕Clinically significant pulmonary hypertension requiring drug therapy
  • ✕Prednisone dose >10 mg/day

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00004563
NCT00004563Phase 3Completed
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Cyclophosphamide Versus Placebo in Scleroderma Lung Study

The University of Texas Health Science Center, Houston·interventional·Posted Feb 10, 2000·Updated Mar 27, 2015

In Brief

A Phase 3 clinical trial evaluating Cyclophosphamide and Placebo for Lung Diseases and 3 related conditions. Completed, enrolled 158 participants.

Detailed Summary

To evaluate the efficacy and safety of cyclophosphamide versus placebo for the prevention and progression of symptomatic pulmonary disease in patients with systemic sclerosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Diseases, Pulmonary Fibrosis, Systemic Scleroderma, Scleroderma, Systemic
Countries--
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 10, 2000
Enrollment StartAug 1, 1999
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 13.8 yearsPosted 26.4 years ago

Interventions

Cyclophosphamidedrug

Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.

Placebodrug

Matching gelcaps 25 mgs