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A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01667471
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : October 2, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Juvenile Idiopathic Arthritis
Intervention Drug: tocilizumab [RoActemra/Actemra]
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously (IV) every 4 weeks up to 104 weeks or until tocilizumab was commercially available for polyarticular-course Juvenile Idiopathic Arthritis (pcJIA).
Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug were included in the Safety Analysis Set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
14.4  (3.2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
6
  85.7%
Male
1
  14.3%
1.Primary Outcome
Title Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events
Hide Description Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab. AEs of special interest were Infections (including all opportunistic infections and non-serious infections as defined by those treated with IV anti-infectives), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related events, Malignancies, Anaphylaxis/Hypersensitivity reactions, Demyelinating disorders, Stroke. Bleeding events, Hepatic events and Macrophage activation syndrome (MAS).
Time Frame Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
Drug related AEs 6
Drug related SAEs 0
AEs of special interest 1
Drug-related AEs of special interest 1
2.Primary Outcome
Title Number of AEs of Special Interest and Study Drug Related AEs
Hide Description AEs and SAEs were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab.
Time Frame Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: adverse events
Drug related AEs 22
Drug related SAEs 0
AEs of special interest 2
Drug-related AEs of special interest 2
3.Secondary Outcome
Title Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit
Hide Description

The six JIA ACR components comprised of: 1) Physician's global assessment of disease activity, 2) Parent/Participant's global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate (ESR) and/or C-reactive Protein (CRP), and 6) Childhood Health Assessment Questionnaire - Disease Index (CHAQ-DI).

At an assessment visit, a JIA ACR30/50/70/90 response in comparison to Baseline was defined as: At least three of the six JIA ACR core components improving by at least 30 percent (%), 50%, 70%, or 90% respectively and no more than one of the remaining JIA ACR core components worsening by more than 30%.

Time Frame Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; number (n) = number of participants analyzed for the given parameter at the specified visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: percentage of participants
Baseline JIA ACR30 (n=7) 85.7
Week 12 JIA ACR30 (n=7) 100.0
Week 24 JIA ACR30 (n=7) 100.0
Week 36 JIA ACR30 (n=7) 100.0
Week 48 JIA ACR30 (n=6) 100.0
Week 60 JIA ACR30 (n=6) 100.0
Week 72 JIA ACR30 (n=2) 100.0
Follow-Up JIA ACR30 (n=7) 100.0
Baseline JIA ACR50 (n=7) 85.7
Week 12 JIA ACR50 (n=7) 100.0
Week 24 JIA ACR50 (n=7) 100.0
Week 36 JIA ACR50 (n=7) 100.0
Week 48 JIA ACR50 (n=6) 100.0
Week 60 JIA ACR50 (n=6) 100.0
Week 72 JIA ACR50 (n=2) 100.0
Follow-Up JIA ACR50 (n=7) 100.0
Baseline JIA ACR70 (n=6) 85.7
Week 12 JIA ACR70 (n=7) 100.0
Week 24 JIA ACR70 (n=7) 100.0
Week 36 JIA ACR70 (n=7) 100.0
Week 48 JIA ACR70 (n=6) 100.0
Week 60 JIA ACR70 (n=6) 100.0
Week 72 JIA ACR70 (n=2) 100.0
Follow-Up JIA ACR70 (n=7) 100.0
Baseline JIA ACR90 (n=6) 85.7
Week 12 JIA ACR90 (n=7) 85.7
Week 24 JIA ACR90 (n=7) 57.1
Week 36 JIA ACR90 (n=7) 71.4
Week 48 JIA ACR90 (n=6) 83.3
Week 60 JIA ACR90 (n=6) 66.7
Week 72 JIA ACR90 (n=2) 100.0
Follow-Up JIA ACR90 (n=7) 85.7
4.Secondary Outcome
Title Percentage of Participants With Inactive Disease by Visit
Hide Description A participant was defined to show inactive disease if all of the following criteria were applied: 1) No joints with active arthritis (no joints with swelling and no joints with lack of motion), 2) No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA, 3) No active uveitis, 4) ESR and/or CRP within normal range, and 5) Physician's global assessment of disease activity equals (=) 0 millimeters (mm) on a Visual analog scale (VAS).
Time Frame Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: percentage of participants
Baseline(n=7) 57.1
Week 12 (n=7) 42.9
Week 24 (n=7) 14.3
Week 36 (n=7) 42.9
Week 48 (n=6) 16.7
Week 60 (n=6) 33.3
Week 72 (n=2) 50.0
Follow-Up (n=7) 57.1
5.Secondary Outcome
Title Percentage of Participants Achieving Clinical Remission (CR) at Each Visit
Hide Description CR was defined as "clinical remission with medication (CRem)". A participant was in CR if inactive disease was observed for a minimum of 6 consecutive months.
Time Frame Baseline, Screening, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n=7) 0.0
Screening (n=7) 0.0
Week 4 (n=7) 0.0
Week 8 (n=7) 0.0
Week 12 (n=7) 0.0
Week 16 (n=7) 0.0
Week 20 (n=7) 0.0
Week 24 (n=7) 0.0
Week 28 (n=7) 14.3
Week 32 (n=7) 14.3
Week 36 (n=7) 14.3
Week 40 (n=6) 16.7
Week 44 (n=6) 16.7
Week 48 (n=6) 16.7
Week 52 (n=6) 16.7
Week 56 (n=6) 16.7
Week 60 (n=6) 0.0
Week 64 (n=5) 0.0
Week 68 (n=3) 0.0
Week 72 (n=2) 0.0
Week 76 (n=1) 0.0
Follow-Up (n=7) 0.0
6.Secondary Outcome
Title Physicians Assessment of Global Activity (VAS)
Hide Description The participant's treating physician provided a rating of the participant's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line, score 0 represented 'arthritis inactive' (ie, symptom-free and no arthritis symptoms) and the extreme right end score 100 represented 'arthritis very active'. A higher score indicated more disease activity.
Time Frame Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; n = number of participants analyzed at the specified visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=7) 12.0  (30.4)
Week 12 (n=7) 2.3  (2.9)
Week 24 (n=7) 5.4  (6.1)
Week 28 (n=1) 1.0  (0.0)
Week 32 (n=2) 29.0  (8.5)
Week 36 (n=7) 5.0  (7.9)
Week 48 (n=6) 5.7  (8.2)
Week 60 (n=6) 5.7  (8.7)
Week 72 (n=2) 1.0  (1.4)
Follow-Up (n=7) 5.0  (8.7)
7.Secondary Outcome
Title Parent or Participant's Assessment of Global Activity (VAS)
Hide Description The participant or parent/guardian, as appropriate, provided a rating of the participant's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line Score 0 represented 'very well' (ie, symptom-free and no arthritis disease activity) and the extreme right end score 100 represented 'very poor' (ie, maximum arthritis disease activity). A higher score indicated poorer well-being.
Time Frame Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; n = number of participants analyzed at the specified visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=7) 10.1  (20.0)
Week 12 (n=7) 7.1  (8.1)
Week 24 (n=7) 16.4  (19.9)
Week 28 (n=1) 1.0  (0.0)
Week 32 (n=2) 22.5  (24.7)
Week 36 (n=7) 12.1  (18.4)
Week 48 (n=6) 11.7  (13.9)
Week 60 (n=6) 10.2  (13.8)
Week 72 (n=2) 3.5  (4.9)
Follow-Up (n=7) 9.7  (16.0)
8.Secondary Outcome
Title Number of Joints With Active Arthritis
Hide Description Joints with active arthritis were defined as joints with swelling or pain and limited of motion. The maximum number of joints with active arthritis was 71.The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant's efficacy and safety data.
Time Frame Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; n = number of participants analyzed at the specified visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: joints
Baseline (n=7) 0.9  (2.3)
Week 12 (n=7) 0.3  (0.8)
Week 24 (n=7) 1.0  (2.6)
Week 28 (n=1) 1.0  (0.0)
Week 32 (n=2) 1.5  (0.7)
Week 36 (n=7) 1.1  (2.2)
Week 48 (n=6) 0.0  (0.0)
Week 60 (n=6) 0.3  (0.8)
Week 72 (n=2) 0.0  (0.0)
Follow-Up (n=7) 0.3  (0.8)
9.Secondary Outcome
Title Number of Joints With Lack of Motion
Hide Description Joints with lack of movement were assessed. The maximum number of joints with lack of movement was 67. The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant's efficacy and safety data.
Time Frame Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; n = number of participants analyzed at the specified visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: joints
Baseline (n=7) 1.4  (2.7)
Week 12 (n=7) 2.6  (5.1)
Week 24 (n=7) 2.4  (3.2)
Week 28 (n=1) 1.0  (0.0)
Week 32 (n=2) 5.5  (7.8)
Week 36 (n=7) 1.7  (2.4)
Week 48 (n=6) 2.7  (5.2)
Week 60 (n=6) 1.8  (3.0)
Week 72 (n=2) 0.0  (0.0)
Follow-Up (n=7) 2.9  (4.8)
10.Secondary Outcome
Title Erythrocyte Sedimentation Rate
Hide Description ESR is a marker of inflammation and was measured as millimeters per hour (mm/h). Healthy individuals have low ESR. Higher ESR indicate inflammation.
Time Frame Baseline, Weeks 4, 8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; n = number of participants analyzed at the specified visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: mm/h
Baseline (n=7) 4.9  (5.1)
Week 4 (n=7) 3.0  (1.9)
Week 8 (n=7) 2.9  (2.3)
Week 12 (n=7) 3.0  (2.0)
Week 16 (n=7) 8.6  (16.1)
Week 20 (n=7) 2.6  (0.8)
Week 24 (n=7) 2.7  (1.4)
Week 28 (n=5) 3.4  (3.1)
Week 32 (n=7) 4.3  (4.2)
Week 36 (n=7) 4.3  (2.5)
Week 40 (n=6) 2.0  (1.8)
Week 44 (n=6) 2.7  (1.5)
Week 48 (n=6) 3.8  (1.5)
Week 52 (n=6) 3.2  (3.6)
Week 56 (n=6) 2.3  (1.6)
Week 60 (n=6) 10.2  (12.7)
Week 64 (n=5) 3.2  (2.4)
Week 68 (n=3) 10.0  (7.2)
Week 72 (n=2) 4.5  (0.7)
Week 76 (n=1) 2.0  (0.0)
Follow-Up (n=7) 4.3  (2.8)
11.Secondary Outcome
Title CHAQ-DI Score
Hide Description The CHAQ-DI questionnaire consisted of 30 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain had at least two component questions and if applicable to the participant there were four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do). The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst).
Time Frame Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; n = number of participants analyzed at the specified visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline (n=7) 0.0  (0.0)
Week 12 (n=7) 0.04  (0.09)
Week 24 (n=7) 0.14  (0.20)
Week 28 (n=1) 0.00  (0.0)
Week 32 (n=2) 0.19  (0.27)
Week 36 (n=7) 0.13  (0.33)
Week 48 (n=6) 0.00  (0.00)
Week 60 (n=6) 0.21  (0.51)
Week 72 (n=2) 0.00  (0.00)
Follow-Up (n=7) 0.00  (0.00)
12.Secondary Outcome
Title Parent or Participant's Assessment of Pain (VAS)
Hide Description Parents or participants rated participant's pain by placing a horizontal line on a VAS of 0 (no pain)- 100 mm (severe pain).
Time Frame Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; n = number of participants analyzed at the specified visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=7) 10.9  (21.8)
Week 12 (n=7) 7.0  (10.0)
Week 24 (n=7) 13.7  (16.7)
Week 28 (n=1) 1.0  (0.0)
Week 32 (n=2) 28.5  (17.7)
Week 36 (n=7) 10.6  (15.9)
Week 48 (n=6) 12.3  (13.6)
Week 60 (n=6) 10.2  (13.8)
Week 72 (n=2) 4.0  (5.7)
Follow-Up (n=7) 9.9  (15.9)
13.Secondary Outcome
Title CRP Levels
Hide Description CRP an acute phase protein, is a marker of inflammation. CRP was measured as milligrams per deciliter (mg/dL).
Time Frame Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Follow-Up Visit (up to 82 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; n = number of participants analyzed at the specified visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline (n=7) 0.03  (0.01)
Week 4 (n=7) 0.05  (0.07)
Week 8 (n=7) 0.02  (0.02)
Week 12 (n=7) 0.03  (0.01)
Week 16 (n=7) 0.23  (0.54)
Week 20 (n=7) 0.05  (0.07)
Week 24 (n=7) 0.03  (0.02)
Week 28 (n=6) 0.02  (0.02)
Week 32 (n=7) 0.03  (0.02)
Week 36 (n=7) 0.02  (0.02)
Week 40 (n=6) 0.03  (0.02)
Week 44 (n=6) 0.03  (0.02)
Week 48 (n=6) 0.03  (0.02)
Week 52 (n=6) 0.02  (0.02)
Week 56 (n=6) 0.03  (0.02)
Week 60 (n=6) 0.38  (0.90)
Week 64 (n=5) 0.03  (0.03)
Week 68 (n=3) 0.09  (0.10)
Week 72 (n=2) 0.04  (0.04)
Week 76 (n=1) 0.05  (0.0)
Follow-Up (n=7) 0.05  (0.06)
Time Frame Adverse events were collected from the date of screening until the final Follow-Up Visit (up to 82 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
All-Cause Mortality
Tocilizumab 8 mg/kg
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Tocilizumab 8 mg/kg
Affected / at Risk (%)
Total   1/7 (14.29%) 
Infections and infestations   
Appendicitis * 1  1/7 (14.29%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tocilizumab 8 mg/kg
Affected / at Risk (%)
Total   7/7 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia * 1  1/7 (14.29%) 
Cardiac disorders   
Aortic valve incompetence * 1  1/7 (14.29%) 
Mitral valve incompetence * 1  1/7 (14.29%) 
Gastrointestinal disorders   
Abdominal pain * 1  2/7 (28.57%) 
Abdominal pain upper * 1  2/7 (28.57%) 
Constipation * 1  1/7 (14.29%) 
Epigastric discomfort * 1  1/7 (14.29%) 
Gastritis * 1  1/7 (14.29%) 
Nausea * 1  2/7 (28.57%) 
Vomiting * 1  1/7 (14.29%) 
General disorders   
Injection site swelling * 1  1/7 (14.29%) 
Local swelling * 1  1/7 (14.29%) 
Vaccination site reaction * 1  1/7 (14.29%) 
Infections and infestations   
Acute tonsillitis * 1  1/7 (14.29%) 
Bronchitis * 1  1/7 (14.29%) 
Cystitis * 1  1/7 (14.29%) 
Gastroenteritis * 1  4/7 (57.14%) 
Herpes simplex * 1  1/7 (14.29%) 
Lice infestation * 1  1/7 (14.29%) 
Nasopharyngitis * 1  1/7 (14.29%) 
Otitis externa * 1  1/7 (14.29%) 
Rhinitis * 1  1/7 (14.29%) 
Scarlet fever * 1  1/7 (14.29%) 
Sinusitis * 1  1/7 (14.29%) 
Upper respiratory tract infection * 1  3/7 (42.86%) 
Vulvovaginal mycotic infection * 1  1/7 (14.29%) 
Injury, poisoning and procedural complications   
Excoriation * 1  1/7 (14.29%) 
Contusion * 1  1/7 (14.29%) 
Fall * 1  1/7 (14.29%) 
Ligament sprain * 1  1/7 (14.29%) 
Investigations   
Biopsy kidney * 1  1/7 (14.29%) 
Hepatic enzyme increased * 1  1/7 (14.29%) 
White blood cell count decreased * 1  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  4/7 (57.14%) 
Foot deformity * 1  1/7 (14.29%) 
Joint effusion * 1  1/7 (14.29%) 
Juvenile idiopathic arthritis * 1  3/7 (42.86%) 
Pain in extremity * 1  1/7 (14.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Skin papilloma * 1  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/7 (14.29%) 
Oropharyngeal pain * 1  1/7 (14.29%) 
Tonsillar disorder * 1  1/7 (14.29%) 
Skin and subcutaneous tissue disorders   
Psoriasis * 1  1/7 (14.29%) 
Urticaria * 1  1/7 (14.29%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
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Name/Title: Medical Communications
Organization: Hoffmann-LaRoche or Genentech, Inc
Phone: 800-821-8590
EMail: genentech@druginfo.com
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01667471    
Other Study ID Numbers: ML25756
2011-001097-25 ( EudraCT Number )
First Submitted: August 15, 2012
First Posted: August 17, 2012
Results First Submitted: July 9, 2015
Results First Posted: October 2, 2015
Last Update Posted: November 2, 2016