Back to resultsA Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
Primary Purpose
Sclerosis, Systemic
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
tocilizumab [RoActemra/Actemra]
tocilizumab [RoActemra/Actemra]
Sponsored by
About this trial
This is an interventional treatment trial for Sclerosis, Systemic
Eligibility Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Systemic sclerosis, as defined by American College of Rheumatology (1980) criteria
- Disease duration of </= 60 months (defined as time from first non-Raynaud phenomenon manifestation)
- >/= 15 and </= 40 mRSS units at screening
- Active disease, as defined by protocol
- Uninvolved skin at injection sites
- Negative pregnancy test for a female subject of childbearing potential
Exclusion Criteria:
- Major surgery (including joint surgery) within 8 weeks prior to and/or during study enrollment
- Rheumatic autoimmune disease other than systemic sclerosis
- Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening
- Previous treatment with tocilizumab
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Severe cardiopulmonary disease
- Known active current or history of recurrent infections
- Use of any investigational, biologic, or immunosuppressive therapies including intra-articular or parenteral corticosteroids prior to study enrollment as specified in the protocol
- As specified in the protocol, any current or past medical condition or medical history involving but not limited to the nervous, renal, pulmonary, endocrine, and gastrointestinal organ systems determined by the Principal Investigator to pose a significant safety risk to any subject while participating in the study
- Primary or secondary immunodeficiency
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Tocilizumab
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 were events between first dose of study drug and up to Week 8 after last dose that were absent before treatment or that worsened relative to pretreatment state.
Secondary Outcome Measures
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
SHAQ-DI assessed five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant's disease. These items were developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant's daily activities. Each VAS item was rated separately (0-100 millimeters [mm]), with higher scores indicating more severe disease. The five items were: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 48
The HAQ-DI scale consisted of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The total score indicated the participant's self-assessed level of disability. There are four possible responses for each component: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The HAQ-DI was the sum of the domain scores, divided by the number of domains that have a score (i.e. the average score), with total range of 0 to 3, higher scores showing larger functional limitation.
Change From Baseline in Clinician's Global Assessment at Week 24 and Week 48
The Clinician's Global Assessment evaluated the overall impact of SSc on the participant as assessed by the physician on a VAS with scores ranging from 0 to 100 mm, with higher scores indicating worse disease in terms of severity, damage, or overall disease, but there was no standardization for the scale.
Change From Baseline in Patient's Global Assessment at Week 24 and Week 48
The Patient's Global Assessment was a patient's reported outcome that represented the participant's overall assessment of his or her current SSc on a 100 mm horizontal VAS scale (0 mm to 100 mm), with higher scores indicating worsening disease.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 and Week 48
This FACIT-Fatigue Scale was a 13-item measure with participants scoring each item on a 5-point scale (0 to 4) up to 52 points. The endpoint measured was fatigue. On this scale, a numerical increase indicated an improvement in the participant's condition.
Change From Baseline in 5-D Itch Scale at Week 24 and Week 48
The 5-D Itch Scale contained five domains of duration, degree, direction, disability, and distribution. The endpoint of the scale was pruritus. Each domain was scored on a 5-point scale, the scores of each of the five domains were achieved separately and then summed together to obtain a total 5-D score. 5-D scores ranged between 5 (no pruritus) and 25 (most severe pruritus).
Change From Baseline in mRSS at Week 48
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
Percentage of Participants Who Maintained or Improved in mRSS From Week 24 to Week 48
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement. Percentage of participants with an improvement in mRSS at Week 24 (change from baseline <0) that maintained or further improved at Week 48 were reported as "Yes" and "No" with Yes = improvers at week 24 that had a change from baseline in mRSS at Week 48 <= change from baseline at Week 24.
Change From Baseline in Tender Joint Count 28 (TJC28)
Joint tenderness was evaluated as per assessment of 28 joints. Joints on both sides of the body, including shoulders, elbows, wrists, 10 metacarpal phalangeal (MCP) joints, 10 proximal interphalangeal joint (PIP) joints, and both knees, were assessed. Joints were classified as not tender = 0 or tender = 1. Observed data was presented for this outcome measure.
Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hour (AUC0-168)
AUC was a measure of the serum concentration of the drug over time which was measured in micrograms times (*) hour per milliliters (µg*hr/mL). It is used to characterize drug absorption.
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Observed data was presented for this outcome measure.
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Observed data was presented for this outcome measure.
Percentage of Participants With Anti-Tocilizumab Antibody
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01532869
Brief Title
A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
Official Title
A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sclerosis, Systemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Tocilizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneously weekly, Weeks 0-48
Intervention Type
Drug
Intervention Name(s)
tocilizumab [RoActemra/Actemra]
Intervention Description
162 mg subcutaneously weekly, Weeks 0-48
Intervention Type
Drug
Intervention Name(s)
tocilizumab [RoActemra/Actemra]
Intervention Description
162 mg subcutaneously weekly, Week 48-96
Primary Outcome Measure Information:
Title
Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24
Description
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
Time Frame
Baseline, Week 24
Title
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 were events between first dose of study drug and up to Week 8 after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)
Description
SHAQ-DI assessed five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant's disease. These items were developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant's daily activities. Each VAS item was rated separately (0-100 millimeters [mm]), with higher scores indicating more severe disease. The five items were: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.
Time Frame
Baseline, Weeks 24 and 48
Title
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 48
Description
The HAQ-DI scale consisted of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The total score indicated the participant's self-assessed level of disability. There are four possible responses for each component: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The HAQ-DI was the sum of the domain scores, divided by the number of domains that have a score (i.e. the average score), with total range of 0 to 3, higher scores showing larger functional limitation.
Time Frame
Baseline, Weeks 24 and 48
Title
Change From Baseline in Clinician's Global Assessment at Week 24 and Week 48
Description
The Clinician's Global Assessment evaluated the overall impact of SSc on the participant as assessed by the physician on a VAS with scores ranging from 0 to 100 mm, with higher scores indicating worse disease in terms of severity, damage, or overall disease, but there was no standardization for the scale.
Time Frame
Baseline, Weeks 24 and 48
Title
Change From Baseline in Patient's Global Assessment at Week 24 and Week 48
Description
The Patient's Global Assessment was a patient's reported outcome that represented the participant's overall assessment of his or her current SSc on a 100 mm horizontal VAS scale (0 mm to 100 mm), with higher scores indicating worsening disease.
Time Frame
Baseline, Weeks 24 and 48
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 and Week 48
Description
This FACIT-Fatigue Scale was a 13-item measure with participants scoring each item on a 5-point scale (0 to 4) up to 52 points. The endpoint measured was fatigue. On this scale, a numerical increase indicated an improvement in the participant's condition.
Time Frame
Baseline, Weeks 24 and 48
Title
Change From Baseline in 5-D Itch Scale at Week 24 and Week 48
Description
The 5-D Itch Scale contained five domains of duration, degree, direction, disability, and distribution. The endpoint of the scale was pruritus. Each domain was scored on a 5-point scale, the scores of each of the five domains were achieved separately and then summed together to obtain a total 5-D score. 5-D scores ranged between 5 (no pruritus) and 25 (most severe pruritus).
Time Frame
Baseline, Weeks 24 and 48
Title
Change From Baseline in mRSS at Week 48
Description
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.
Time Frame
Baseline, Week 48
Title
Percentage of Participants Who Maintained or Improved in mRSS From Week 24 to Week 48
Description
Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement. Percentage of participants with an improvement in mRSS at Week 24 (change from baseline <0) that maintained or further improved at Week 48 were reported as "Yes" and "No" with Yes = improvers at week 24 that had a change from baseline in mRSS at Week 48 <= change from baseline at Week 24.
Time Frame
Week 48
Title
Change From Baseline in Tender Joint Count 28 (TJC28)
Description
Joint tenderness was evaluated as per assessment of 28 joints. Joints on both sides of the body, including shoulders, elbows, wrists, 10 metacarpal phalangeal (MCP) joints, 10 proximal interphalangeal joint (PIP) joints, and both knees, were assessed. Joints were classified as not tender = 0 or tender = 1. Observed data was presented for this outcome measure.
Time Frame
Baseline, Weeks 3, 8, 16, 24, 32, 40, and 48
Title
Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hour (AUC0-168)
Description
AUC was a measure of the serum concentration of the drug over time which was measured in micrograms times (*) hour per milliliters (µg*hr/mL). It is used to characterize drug absorption.
Time Frame
Pre-dose, 24, 48, 72, 96, 120 or 144, and 168 hours post dose for Baseline and Week 16
Title
Mean Serum Concentrations of Interleukin (IL)-6 by Visit
Description
Observed data was presented for this outcome measure.
Time Frame
Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48
Title
Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit
Description
Observed data was presented for this outcome measure.
Time Frame
Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48
Title
Percentage of Participants With Anti-Tocilizumab Antibody
Time Frame
Baseline, and post-baseline (up to Week 48)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, >/= 18 years of age
Systemic sclerosis, as defined by American College of Rheumatology (1980) criteria
Disease duration of </= 60 months (defined as time from first non-Raynaud phenomenon manifestation)
>/= 15 and </= 40 mRSS units at screening
Active disease, as defined by protocol
Uninvolved skin at injection sites
Negative pregnancy test for a female subject of childbearing potential
Exclusion Criteria:
Major surgery (including joint surgery) within 8 weeks prior to and/or during study enrollment
Rheumatic autoimmune disease other than systemic sclerosis
Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening
Previous treatment with tocilizumab
History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
Severe cardiopulmonary disease
Known active current or history of recurrent infections
Use of any investigational, biologic, or immunosuppressive therapies including intra-articular or parenteral corticosteroids prior to study enrollment as specified in the protocol
As specified in the protocol, any current or past medical condition or medical history involving but not limited to the nervous, renal, pulmonary, endocrine, and gastrointestinal organ systems determined by the Principal Investigator to pose a significant safety risk to any subject while participating in the study
Primary or secondary immunodeficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
44122
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5317
Country
United States
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0934
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Bordeaux
ZIP/Postal Code
33075
Country
France
City
Caen
ZIP/Postal Code
14033
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Paris
ZIP/Postal Code
75679
Country
France
City
Strasbourg
ZIP/Postal Code
67091
Country
France
City
Toulouse
ZIP/Postal Code
31000
Country
France
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
City
Baden-Baden
ZIP/Postal Code
76530
Country
Germany
City
Berlin
ZIP/Postal Code
10177
Country
Germany
City
Bochum
ZIP/Postal Code
44791
Country
Germany
City
Dresden
ZIP/Postal Code
01067
Country
Germany
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
City
Köln
ZIP/Postal Code
50937
Country
Germany
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany
City
Cannock
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33294861
Citation
Gao X, Jia G, Guttman A, DePianto DJ, Morshead KB, Sun KH, Ramamoorthi N, Vander Heiden JA, Modrusan Z, Wolters PJ, Jahreis A, Arron JR, Khanna D, Ramalingam TR. Osteopontin Links Myeloid Activation and Disease Progression in Systemic Sclerosis. Cell Rep Med. 2020 Nov 17;1(8):100140. doi: 10.1016/j.xcrm.2020.100140. eCollection 2020 Nov 17.
Results Reference
derived
PubMed Identifier
29858547
Citation
Stifano G, Sornasse T, Rice LM, Na L, Chen-Harris H, Khanna D, Jahreis A, Zhang Y, Siegel J, Lafyatis R. Skin Gene Expression Is Prognostic for the Trajectory of Skin Disease in Patients With Diffuse Cutaneous Systemic Sclerosis. Arthritis Rheumatol. 2018 Jun;70(6):912-919. doi: 10.1002/art.40455.
Results Reference
derived
PubMed Identifier
29853453
Citation
Denton CP, Ong VH, Xu S, Chen-Harris H, Modrusan Z, Lafyatis R, Khanna D, Jahreis A, Siegel J, Sornasse T. Therapeutic interleukin-6 blockade reverses transforming growth factor-beta pathway activation in dermal fibroblasts: insights from the faSScinate clinical trial in systemic sclerosis. Ann Rheum Dis. 2018 Sep;77(9):1362-1371. doi: 10.1136/annrheumdis-2018-213031. Epub 2018 May 31.
Results Reference
derived
PubMed Identifier
29066464
Citation
Khanna D, Denton CP, Lin CJF, van Laar JM, Frech TM, Anderson ME, Baron M, Chung L, Fierlbeck G, Lakshminarayanan S, Allanore Y, Pope JE, Riemekasten G, Steen V, Muller-Ladner U, Spotswood H, Burke L, Siegel J, Jahreis A, Furst DE. Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate). Ann Rheum Dis. 2018 Feb;77(2):212-220. doi: 10.1136/annrheumdis-2017-211682. Epub 2017 Oct 24.
Results Reference
derived
PubMed Identifier
27156934
Citation
Khanna D, Denton CP, Jahreis A, van Laar JM, Frech TM, Anderson ME, Baron M, Chung L, Fierlbeck G, Lakshminarayanan S, Allanore Y, Pope JE, Riemekasten G, Steen V, Muller-Ladner U, Lafyatis R, Stifano G, Spotswood H, Chen-Harris H, Dziadek S, Morimoto A, Sornasse T, Siegel J, Furst DE. Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial. Lancet. 2016 Jun 25;387(10038):2630-2640. doi: 10.1016/S0140-6736(16)00232-4. Epub 2016 May 5. Erratum In: Lancet. 2018 Apr 7;391(10128):1356.
Results Reference
derived
Learn more about this trial
A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
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