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A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA) (JIGSAW 117)

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ClinicalTrials.gov Identifier: NCT01904279
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : March 16, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Juvenile Idiopathic Arthritis
Intervention Drug: Tocilizumab
Enrollment 52
Recruitment Details A total of 52 participants were enrolled in the study. Study included a 21-day screening period.
Pre-assignment Details  
Arm/Group Title TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
Hide Arm/Group Description Participants with body weight less than (<) 30 kilograms (kg) were administered 162 milligrams (mg) of TCZ as an subcutaneous (SC) injection every 3 weeks (Q3W) for 52 weeks. Participants with body weight greater than or equal to (>/=) 30 kg were administered 162 mg of TCZ as an SC injection every 2 weeks (Q2W) for 52 weeks.
Period Title: Overall Study
Started 27 25
Completed 24 22
Not Completed 3 3
Reason Not Completed
Lack of Efficacy             2             3
Withdrawal by Subject             1             0
Arm/Group Title TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W Total
Hide Arm/Group Description Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks. Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks. Total of all reporting groups
Overall Number of Baseline Participants 27 25 52
Hide Baseline Analysis Population Description
Safety population included all participants who received at least one dose of treatment and who had at least one post-dose safety assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 25 participants 52 participants
5.5  (2.1) 13.9  (2.7) 9.6  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 25 participants 52 participants
Female
18
  66.7%
18
  72.0%
36
  69.2%
Male
9
  33.3%
7
  28.0%
16
  30.8%
1.Primary Outcome
Title Minimum Serum Concentration (Cmin) of TCZ at Steady State
Hide Description Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
Time Frame Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population included all enrolled participants who were adherent to the protocol.
Arm/Group Title TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
Hide Arm/Group Description:
Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
Overall Number of Participants Analyzed 27 25
Median (Full Range)
Unit of Measure: Micrograms/milliliter (mcg/mL)
13.35
(0.21 to 52.25)
12.71
(0.19 to 23.75)
2.Primary Outcome
Title Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment
Hide Description Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose.
Time Frame Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population.
Arm/Group Title TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
Hide Arm/Group Description:
Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
Overall Number of Participants Analyzed 27 25
Mean (Full Range)
Unit of Measure: mcg*day/mL
2998
(1465 to 7708)
1933
(324 to 3098)
3.Primary Outcome
Title Maximum Serum Concentration (Cmax) of TCZ at Steady State
Hide Description Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
Time Frame Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population
Arm/Group Title TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
Hide Arm/Group Description:
Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
Overall Number of Participants Analyzed 27 25
Median (Full Range)
Unit of Measure: mcg/mL
62.44
(39.37 to 121.13)
29.74
(7.56 to 50.3)
4.Secondary Outcome
Title Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Hide Description IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset. It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity.
Time Frame Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category.
Arm/Group Title TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
Hide Arm/Group Description:
Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
Overall Number of Participants Analyzed 18 23
Mean (Standard Deviation)
Unit of Measure: picograms/milliliter (pg/mL)
Baseline Number Analyzed 18 participants 23 participants
77.569  (278.376) 10.567  (11.24)
Day 0.25 Number Analyzed 18 participants 23 participants
-15.309  (108.157) 4.575  (7.555)
Day 0.5 Number Analyzed 15 participants 23 participants
-16.181  (116.587) 11.932  (13.33)
Day 2 Number Analyzed 18 participants 23 participants
17.998  (157.295) 23.223  (23.935)
Day 4 Number Analyzed 0 participants 0 participants
Day 5 Number Analyzed 17 participants 23 participants
17.265  (186.212) 35.263  (64.907)
Week 2 Number Analyzed 0 participants 23 participants
21.751  (49.964)
Week 3 Number Analyzed 18 participants 0 participants
-12.801  (198.038)
Week 4 Number Analyzed 0 participants 22 participants
15.944  (26.322)
Week 6 Number Analyzed 18 participants 23 participants
-0.412  (271.409) 17.841  (34.515)
Week 12 Number Analyzed 16 participants 21 participants
-45.569  (294.169) 17.236  (28.727)
Day 84.25 Number Analyzed 14 participants 21 participants
32.644  (65.094) 14.66  (24.026)
Day 84.5 Number Analyzed 13 participants 20 participants
-46.575  (318.217) 24.478  (31.747)
Day 85 Number Analyzed 0 participants 22 participants
27.934  (53.23)
Day 86 Number Analyzed 16 participants 21 participants
-53.35  (285.831) 36.06  (82.547)
Day 88 Number Analyzed 17 participants 21 participants
-42.836  (280.041) 19.397  (22.712)
Day 90 Number Analyzed 15 participants 19 participants
-51.899  (299.59) 20.642  (20.247)
Week 14 Number Analyzed 0 participants 23 participants
11.958  (16.665)
Week 15 Number Analyzed 17 participants 1 participants
-21.565  (312.758) 122.88
Week 27 Number Analyzed 18 participants 0 participants
-16.408  (293.156)
Week 28 Number Analyzed 0 participants 20 participants
14.206  (20.762)
Week 36 Number Analyzed 16 participants 16 participants
-38.921  (303.851) 13.273  (24.814)
Week 44 Number Analyzed 0 participants 20 participants
14.765  (18.458)
Week 52 Number Analyzed 17 participants 20 participants
-44.611  (289.698) 10.401  (18.455)
5.Secondary Outcome
Title Change From Baseline in Soluble IL-6 Receptor Levels
Hide Description [Not Specified]
Time Frame Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category.
Arm/Group Title TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
Hide Arm/Group Description:
Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
Overall Number of Participants Analyzed 20 23
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
Baseline Number Analyzed 20 participants 23 participants
140.4  (225.72) 206.7  (241.69)
Day 0.25 Number Analyzed 19 participants 23 participants
-4.04  (41.14) 1.78  (29.68)
Day 0.5 Number Analyzed 16 participants 22 participants
-1.45  (53.39) 4.58  (51.71)
Day 2 Number Analyzed 19 participants 23 participants
89.72  (75.29) 68.90  (66.75)
Day 4 Number Analyzed 1 participants 0 participants
323.4 [1]   (NA)
Day 5 Number Analyzed 19 participants 23 participants
194.46  (143.28) 124.65  (100.58)
Week 2 Number Analyzed 0 participants 23 participants
193.25  (158.69)
Week 3 Number Analyzed 20 participants 0 participants
418.54  (237.02)
Week 4 Number Analyzed 0 participants 23 participants
239.86  (194.47)
Week 6 Number Analyzed 20 participants 23 participants
407.36  (344.44) 233.82  (234.92)
Week 12 Number Analyzed 17 participants 21 participants
464.77  (317.77) 286.06  (260.33)
Day 84.25 Number Analyzed 17 participants 23 participants
461.85  (280.99) 245.05  (253.45)
Day 84.5 Number Analyzed 17 participants 22 participants
482.55  (299.43) 274.85  (230.86)
Day 85 Number Analyzed 0 participants 22 participants
268.72  (254.46)
Day 86 Number Analyzed 19 participants 22 participants
461.19  (345.97) 244.53  (257.08)
Day 88 Number Analyzed 19 participants 21 participants
514.89  (303.29) 256.47  (234.7)
Day 90 Number Analyzed 19 participants 20 participants
494.05  (276.35) 292.29  (229.2)
Week 14 Number Analyzed 0 participants 23 participants
272.93  (241.9)
Week 15 Number Analyzed 20 participants 1 participants
497.21  (295.29) 200 [1]   (NA)
Week 27 Number Analyzed 20 participants 0 participants
532.81  (270.07)
Week 28 Number Analyzed 0 participants 21 participants
295.28  (286.78)
Week 36 Number Analyzed 18 participants 18 participants
416.02  (305.07) 269.32  (276.03)
Week 44 Number Analyzed 0 participants 21 participants
243.93  (299.72)
Week 52 Number Analyzed 20 participants 22 participants
470.6  (263.38) 209.51  (318.38)
[1]
The data was not available as single participant was evaluated.
6.Secondary Outcome
Title Change From Baseline in C-Reactive Protein (CRP) Levels
Hide Description [Not Specified]
Time Frame Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number Analyzed represents participants evaluable for the specified category.
Arm/Group Title TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
Hide Arm/Group Description:
Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline Number Analyzed 27 participants 25 participants
3.391  (5.27) 3.356  (6.908)
Week 4 Number Analyzed 0 participants 25 participants
-2.187  (5.270)
Week 6 Number Analyzed 27 participants 25 participants
-3  (5.21) -2.368  (5.735)
Week 9 Number Analyzed 27 participants 0 participants
-3.069  (5.346)
Week 12 Number Analyzed 27 participants 24 participants
-3.16  (5.285) -1.783  (4.559)
Week 18 Number Analyzed 26 participants 0 participants
-3.213  (5.377)
Week 20 Number Analyzed 0 participants 25 participants
-1.336  (6.158)
Week 27 Number Analyzed 27 participants 0 participants
-3.122  (5.279)
Week 28 Number Analyzed 0 participants 25 participants
-2.467  (6.455)
Week 36 Number Analyzed 25 participants 22 participants
-3.254  (5.492) -2.209  (5.316)
Week 44 Number Analyzed 0 participants 22 participants
-2.039  (5.47)
Week 45 Number Analyzed 26 participants 0 participants
-3.153  (5.385)
Week 51 Number Analyzed 25 participants 0 participants
-3.344  (5.453)
Week 52 Number Analyzed 0 participants 22 participants
-2.225  (5.285)
7.Secondary Outcome
Title Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Hide Description The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.
Time Frame Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Number Analyzed represents participants evaluable for the specified category.
Arm/Group Title TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
Hide Arm/Group Description:
Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 Weeks.
Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: millimeters per hour (mm/h)
Baseline Number Analyzed 27 participants 25 participants
15.9  (14.2) 13  (13.1)
Week 4 Number Analyzed 0 participants 25 participants
-7.0  (9)
Week 6 Number Analyzed 26 participants 25 participants
-10.6  (12.8) -7.2  (10.5)
Week 9 Number Analyzed 25 participants 0 participants
-9.9  (10.9)
Week 12 Number Analyzed 26 participants 25 participants
-9.8  (12.4) -6.8  (13)
Week 18 Number Analyzed 26 participants 0 participants
-11.8  (12.3)
Week 20 Number Analyzed 0 participants 25 participants
-7.9  (11.2)
Week 27 Number Analyzed 27 participants 0 participants
-11.9  (12.2)
Week 28 Number Analyzed 0 participants 23 participants
-8  (14.2)
Week 36 Number Analyzed 26 participants 21 participants
-11.8  (12.8) -8  (13.1)
Week 44 Number Analyzed 0 participants 21 participants
-10.2  (13)
Week 45 Number Analyzed 26 participants 0 participants
-12  (12.2)
Week 51 Number Analyzed 25 participants 0 participants
-12.2  (13)
Week 52 Number Analyzed 0 participants 22 participants
-8.5  (13.2)
8.Secondary Outcome
Title Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential
Hide Description [Not Specified]
Time Frame Baseline up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
Hide Arm/Group Description:
Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
Overall Number of Participants Analyzed 27 25
Measure Type: Number
Unit of Measure: percentage of participants
3.7 8.0
Time Frame Baseline up to Week 56
Adverse Event Reporting Description Safety population
 
Arm/Group Title TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
Hide Arm/Group Description Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks. Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
All-Cause Mortality
TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
Affected / at Risk (%) Affected / at Risk (%)
Total   1/27 (3.70%)   2/25 (8.00%) 
Infections and infestations     
Croup infectious * 1  1/27 (3.70%)  0/25 (0.00%) 
Varicella * 1  1/27 (3.70%)  0/25 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  0/27 (0.00%)  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/27 (0.00%)  1/25 (4.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
TCZ SC 162 mg Q3W TCZ SC 162 mg Q2W
Affected / at Risk (%) Affected / at Risk (%)
Total   23/27 (85.19%)   22/25 (88.00%) 
Blood and lymphatic system disorders     
Neutropenia * 1  3/27 (11.11%)  1/25 (4.00%) 
Ear and labyrinth disorders     
Ear Pain * 1  2/27 (7.41%)  1/25 (4.00%) 
Gastrointestinal disorders     
Abdominal Pain * 1  3/27 (11.11%)  3/25 (12.00%) 
Aphthous Ulcer * 1  1/27 (3.70%)  3/25 (12.00%) 
Constipation * 1  2/27 (7.41%)  1/25 (4.00%) 
Diarrhoea * 1  1/27 (3.70%)  4/25 (16.00%) 
Nausea * 1  1/27 (3.70%)  5/25 (20.00%) 
Vomiting * 1  4/27 (14.81%)  5/25 (20.00%) 
General disorders     
Fatigue * 1  0/27 (0.00%)  2/25 (8.00%) 
Injection Site Erythema * 1  4/27 (14.81%)  6/25 (24.00%) 
Injection Site Haematoma * 1  0/27 (0.00%)  2/25 (8.00%) 
Injection Site Pain * 1  0/27 (0.00%)  2/25 (8.00%) 
Injection Site Pruritus * 1  0/27 (0.00%)  2/25 (8.00%) 
Injection Site Swelling * 1  1/27 (3.70%)  2/25 (8.00%) 
Pyrexia * 1  2/27 (7.41%)  4/25 (16.00%) 
Vessel Puncture Site Haematoma * 1  0/27 (0.00%)  2/25 (8.00%) 
Infections and infestations     
Bronchitis * 1  2/27 (7.41%)  1/25 (4.00%) 
Ear Infection * 1  4/27 (14.81%)  0/25 (0.00%) 
Gastroenteritis * 1  4/27 (14.81%)  2/25 (8.00%) 
Impetigo * 1  2/27 (7.41%)  0/25 (0.00%) 
Influenza * 1  2/27 (7.41%)  0/25 (0.00%) 
Nasophryngitis * 1  11/27 (40.74%)  7/25 (28.00%) 
Otitis Media * 1  3/27 (11.11%)  0/25 (0.00%) 
Paronychia * 1  0/27 (0.00%)  2/25 (8.00%) 
Rhinitis * 1  1/27 (3.70%)  3/25 (12.00%) 
Upper Respiratory Tract Infection * 1  1/27 (3.70%)  4/25 (16.00%) 
Viral Infection * 1  2/27 (7.41%)  0/25 (0.00%) 
Investigations     
Alanine Aminotransferase Increased * 1  1/27 (3.70%)  2/25 (8.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  5/27 (18.52%)  4/25 (16.00%) 
Back Pain * 1  3/27 (11.11%)  1/25 (4.00%) 
Joint Swelling * 1  0/27 (0.00%)  2/25 (8.00%) 
Juvenile Idiopathic Arthritis * 1  1/27 (3.70%)  3/25 (12.00%) 
Neck Pain * 1  2/27 (7.41%)  1/25 (4.00%) 
Pain in extremity * 1  1/27 (3.70%)  4/25 (16.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin Papilloma * 1  1/27 (3.70%)  2/25 (8.00%) 
Nervous system disorders     
Headache * 1  1/27 (3.70%)  6/25 (24.00%) 
Psychiatric disorders     
Insomnia * 1  2/27 (7.41%)  2/25 (8.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  10/27 (37.04%)  3/25 (12.00%) 
Epistaxis * 1  0/27 (0.00%)  2/25 (8.00%) 
Oropharyngeal Pain * 1  1/27 (3.70%)  3/25 (12.00%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  0/27 (0.00%)  2/25 (8.00%) 
Dermatitis Atopic * 1  2/27 (7.41%)  0/25 (0.00%) 
Eczema * 1  2/27 (7.41%)  3/25 (12.00%) 
Rash * 1  0/27 (0.00%)  2/25 (8.00%) 
Vascular disorders     
Haematoma * 1  1/27 (3.70%)  2/25 (8.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (19.0)
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
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01904279    
Other Study ID Numbers: WA28117
2012-003486-18 ( EudraCT Number )
First Submitted: June 14, 2013
First Posted: July 22, 2013
Results First Submitted: January 24, 2017
Results First Posted: March 16, 2017
Last Update Posted: June 14, 2017