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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01933334
Other study ID # PSSc-001
Secondary ID
Status Completed
Phase Phase 2
First received August 23, 2013
Last updated August 25, 2015
Start date September 2013
Est. completion date September 2014

Study information

Verified date August 2015
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health CanadaItaly: Agenzia Italiana del Farmaco
Study type Interventional

Clinical Trial Summary

PSSc-001 (LOTUSS)

This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in patients with systemic sclerosis−related interstitial lung disease (SSc-ILD).


Description:

This study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in patients with systemic sclerosis−related interstitial lung disease (SSc-ILD)


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. Diagnosis of SSc confirmed by the American College of Rheumatology classification criteria of systemic sclerosis (Masi 1980); duration of diagnosis <7 years

2. Diagnosis of SSc-ILD based on an HRCT scan

3. Screening FVC =50% of the predicted value, and screening DLCO =40% of the predicted value

4. At study entry, the patient either is not taking SSc-ILD medication or is taking cyclophosphamide or mycophenolate mofetil

Exclusion Criteria:

1. Clinically significant pulmonary hypertension

2. Known underlying liver disease

3. Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux

4. History of clinically significant asthma or chronic obstructive pulmonary disease

5. Active infection

6. Diagnosis of another connective tissue disorder

7. Evidence of a malignancy that is likely to result in significant disability or require significant medical or surgical intervention

8. History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD)

9. Pregnancy or lactation

10. Creatinine clearance <40 mL/min

11. Prior use of pirfenidone

12. Unsuitable for enrollment or unlikely to comply with study requirements.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Pirfenidone
antifibrotic drug

Locations

Country Name City State
Canada St. Joseph's Healthcare Hamilton Ontario
Canada Toronto General Hospital Toronto Ontario
Italy University of Florence Firenze
Italy Università di Torino Orbassano Turin
United States University of Michigan Ann Arbor Michigan
United States Boston University Medical Center Boston Massachusetts
United States Medical University South Carolina Charleston South Carolina
United States Northwestern University, Chicago Chicago Illinois
United States University of Cincinnati Cincinnati Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States National Jewish Medical and Research Center Denver Colorado
United States University of Texas, Houston Houston Texas
United States University of California, Los Angeles Los Angeles California
United States Columbia University New York New York
United States Hospital for Special Surgery New York New York
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Stanford University School of Medicine Redwood City California
United States University of Utah Salt Lake City Utah
United States University of California, San Francisco San Francisco California
United States Mayo Clinic, Scottsdale Scottsdale Arizona
United States University of Toledo Toledo Ohio
United States Georgetown University Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Italy, 

References & Publications (1)

Preliminary criteria for the classification of systemic sclerosis (scleroderma). Subcommittee for scleroderma criteria of the American Rheumatism Association Diagnostic and Therapeutic Criteria Committee. Arthritis Rheum. 1980 May;23(5):581-90. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Treatment-Emergent Adverse Events (AEs) Percentage of participants who had treatment-emergent AEs, defined as newly occurring or worsening after first dose. Relatedness to (study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. From baseline up to 28 days after the last dose of study drug (last dose = Week 16) No
Primary Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. From baseline up to 28 days after the last dose of study drug (last dose = Week 16) No
Secondary University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores UCLA SCTC GIT Scale 2.0 is a 34-item self-administered questionnaire to obtain participant's assessment of the frequency of GI symptoms in preceding 7 days and how symptoms affected his/her life. All but 2 items were scored on a 0 to 3 scale (0=better health, 3=worse health); remaining 2 items were scored as 0 (better health) and 1 (worse health). The 34 items are divided into seven scales (reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being, and constipation). Individual scale score was calculated as the average of the items in the scale. Individual scale score ranged from 0 to 3 for reflux, distention/bloating, fecal soilage, social functioning, and emotional well-being; 0 to 2 for diarrhea; and 0 to 2.5 for constipation. A total score was also calculated as the average of 6 of the 7 scales (omitting constipation) and ranged from 0 to 2.83. For individual and total scores 0 indicated better health and higher score indicates worse health. Baseline, Weeks 4, 8, 12, and 16 No
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