Clinical Trial Results:
An Extension Study to Evaluate Long Term Safety of Subcutaneous Tocilizumab in Subjects with Giant Cell Arteritis Who Have Completed WA28119 Core Study in France, and Subsequently having Flare or Persisting Disease Activity.
Summary
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EudraCT number |
2016-002716-41 |
Trial protocol |
FR |
Global end of trial date |
23 Aug 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Sep 2020
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First version publication date |
05 Sep 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ML39425
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03202368 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
F. Hoffmann-La Roche AG
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Sponsor organisation address |
Grenzacherstrasse 124, Basel, Switzerland, CH-4070
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Public contact |
F. Hoffmann-La Roche AG, Roche Trial Information Hotline, +41 61 6878333, global.trial_information@roche.com
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Scientific contact |
F. Hoffmann-La Roche AG, Roche Trial Information Hotline, +41 61 6878333, global.trial_information@roche.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Jul 2020
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Aug 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
This is a multicenter, interventional, open-label, long-term extension study of Study WA28119 (NCT01791153) to evaluate the long-term safety of SC tocilizumab in subjects with GCA who subsequently have flare or persisting disease activity.
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Protection of trial subjects |
All study subjects were required to read and sign and Informed Consent Form. The study was conducted in accordance with the principles of the “Declaration of Helsinki” and Good Clinical Practice.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Oct 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 3
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Worldwide total number of subjects |
3
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EEA total number of subjects |
3
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||
Pre-assignment
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Screening details |
Subjects who were treated with tocilizumab in Study WA28119 and experienced a new GCA flare within 3 years after completion of Study WA28119 or had persistent active GCA at the time of completion of Study WA28119, will receive SC tocilizumab in this study. | ||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Tocilizumab: GCA Flare or Persistent Disease Activity | ||||||||||
Arm description |
Subjects who were treated with tocilizumab in Study WA28119 and experienced a new GCA flare within 3 years after completion of Study WA28119 or had persistent active GCA at the time of completion of Study WA28119. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Tocilizumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
162 milligrams (mg) of tocilizumab every week for a maximum of 156 weeks or until the commercial availability of tocilizumab, whichever comes first.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
Subjects who were treated with tocilizumab in Study WA28119 and experienced a new GCA flare within 3 years after completion of Study WA28119 or had persistent active GCA at the time of completion of Study WA28119. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Tocilizumab: GCA Flare or Persistent Disease Activity
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Reporting group description |
Subjects who were treated with tocilizumab in Study WA28119 and experienced a new GCA flare within 3 years after completion of Study WA28119 or had persistent active GCA at the time of completion of Study WA28119. |
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End point title |
Percentage of subjects with Adverse Events [1] | ||||||||||||
End point description |
Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline
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End point type |
Primary
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End point timeframe |
Baseline up to 160 weeks
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis provided. |
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No statistical analyses for this end point |
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End point title |
GCA Disease Activity, as Assessed by the Investigator Based on Visual Analogue Scale Score | ||||||
End point description |
Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 48, 96, 156
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Notes [2] - Only descriptive analysis at each study visit was performed. |
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No statistical analyses for this end point |
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End point title |
Patient Global Assessment of Disease Activity Disease Activity, as Assessed Based on Visual Analogue Scale Score | ||||||
End point description |
Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 48, 96, 156
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Notes [3] - Only descriptive analysis at each study visit was performed. |
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No statistical analyses for this end point |
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End point title |
Change from Baseline in Erythrocyte Sedimentation Rate Values | ||||||
End point description |
Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 48, 96, 156
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Notes [4] - Only descriptive analysis at each study visit was performed. |
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No statistical analyses for this end point |
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End point title |
Change from Baseline in C-Reactive Protein Values | ||||||
End point description |
Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0), Weeks 48, 96, 156
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Notes [5] - Only descriptive analysis at each study visit was performed. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects Who Receive Concomitant Medications With SC Tocilizumab | ||||||
End point description |
Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
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End point type |
Secondary
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End point timeframe |
Baseline up to 156 weeks
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Notes [6] - Only descriptive analysis at each study visit was performed. |
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No statistical analyses for this end point |
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End point title |
Number of SC Tocilizumab Injections Administered | ||||||
End point description |
Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
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End point type |
Secondary
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End point timeframe |
Baseline up to 156 weeks
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Notes [7] - Only descriptive analysis at each study visit was performed. |
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No statistical analyses for this end point |
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End point title |
Total SC Tocilizumab Dose Administered | ||||||
End point description |
Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
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End point type |
Secondary
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End point timeframe |
Baseline up to 156 weeks
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Notes [8] - Only descriptive analysis at each study visit was performed. |
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No statistical analyses for this end point |
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End point title |
Duration of SC Tocilizumab Treatment | ||||||
End point description |
Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
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End point type |
Secondary
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End point timeframe |
Baseline up to 156 weeks
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Notes [9] - Only descriptive analysis at each study visit was performed. |
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No statistical analyses for this end point |
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End point title |
Duration of SC Tocilizumab Interruption | ||||||
End point description |
Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
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End point type |
Secondary
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End point timeframe |
Baseline up to 156 weeks
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Notes [10] - Only descriptive analysis at each study visit was performed. |
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No statistical analyses for this end point |
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End point title |
Duration Between Last Tocilizumab Administration in Study WA28119 and First Tocilizumab Administration in Current Study | ||||||
End point description |
Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
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End point type |
Secondary
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End point timeframe |
From last tocilizumab administration in Study WA28119 to first tocilizumab administration in current study (approximately up to 3 years; assessed retrospectively at Baseline)
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Notes [11] - Only descriptive analysis at each study visit was performed. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Baseline up to 160 weeks
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.1
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Reporting groups
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Reporting group title |
Tocilizumab: GCA Flare or Persistent Disease Activity
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Reporting group description |
Subjects who were treated with tocilizumab in Study WA28119 and experienced a new GCA flare within 3 years after completion of Study WA28119 or had persistent active GCA at the time of completion of Study WA28119. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |