Phase III Study of Tocilizumab in Patients with Systemic Sclerosis
- Conditions
- Systemic Sclerosis
- Registration Number
- JPRN-jRCT2080222911
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
The primary end point was not met; however, clinically meaningful differences in FVC were shown in this trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 212
(1)Age >= 18 years at baseline (Day1)
(2)Diagnosis of SSc, as defined using the American College of Rheumatology/EULAR criteria
(3)SSc disease duration of =< 60 months(defined as time from the first non-Raynaud phenomenon manifestation)
(4)mRSS of >= 10 and =< 35 units at screening
(5)Active disease that meets at least one of the following criteria at screening:
-Disease duration of =< 18 months defined as time from the first non-Raynaud phenomenon manifestation
-Increase in mRSS of >= 3 units compared with the most recent assessment performed within the previous 6 months
-Involvement of one new body area and an increase in mRSS of >= 2 units compared with the most recent assessment performed within the previous 6 months
-Involvement of two new body areas within the previous 6 months
-Presence of at least one tendon friction rub
(6)Uninvolved or mildly thickened skin at one of the following possible injection-site locations:
-Front, middle region of the thigh
-Abdomen, except for the 2-inch area directly around the navel
-Outer area of the upper arm(if a patient caregiver is giving the injection)
(1)Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening
(2)Rheumatic autoimmune disease other than SSc, including but not limited to RA (diagnosed using ACR/EULAR criteria), systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, dermatomyositis, eosinophilic fasciitis, primary Sjogren's syndrome, and eosinophilic myalgia syndrome, as determined by the investigator
(3)Previous treatment with anti-IL6 therapy (including and not limited to TCZ)
(4)Treatment with cyclophosphamide within 6 months prior to baseline
(5)Pulmonary disease with FVC =< 55% of predicted (best of three acceptable and repeatable measurements as described in the site's Pulmonary Function Testing Manual) OR DLCO =< 45% of predicted (corrected for hemoglobin, and the average of the 2 highest acceptable and repeatable measurements as described in the Pulmonary Function Testing Manual)
(6)Class II or higher PAH, as defined by the World Health Organization
(7)Treatment with non-investigational or investigational cell-depleting therapies,
including but not limited to alemtuzumab, anti-CD4, anti-CD5, anti-CD3, anti-CD19,and anti-CD20 within 18 months of baseline; or if treatment prior to 18 months from baseline, evidence of peripheral depletion of targeted lymphocyte subset at screening
(8)History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method