SUSTAIN: Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis
Study Details
Study Description
Brief Summary
Primary Objective:
- To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS)
Secondary Objective:
- To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
The maximum study duration per participant was to be 267 weeks (approximately 5 years) broken down as follows:
-
screening up to a maximum of 1 week;
-
treatment up to a maximum of 260 weeks;
-
follow-up of 6 weeks after treatment discontinuation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sarilumab Sarilumab 150 mg subcutaneous (SC) injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first. |
Drug: Sarilumab
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Experiencing Any Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and Treatment Discontinuation [Baseline up to the end of study (66 weeks)]
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of the relationship to the investigational medicinal product (IMP). SAE was any untoward medical occurrence that at any dose resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the TEAE period (time from first dose of IMP up to the end of follow-up period).
Secondary Outcome Measures
- Percentage of Participants Who Achieved 20% Response in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) [Baseline up to the end of treatment (60 weeks)]
Treatment response for ASAS20 was defined as: Improvement of ≥ 20% and ≥ 1 unit on a 0 (least) to 10 (worst) numerical rating score (NRS) in at least 3 of the 4 ASAS improvement criteria (ASASIC) domains, and no worsening of ≥ 20% and ≥ 1 unit on 0-10 NRS in the remaining domain. The 4 domains included were participant's global disease activity assessment, total back pain, physical function (Bath Ankylosing Spondylitis Functional Index), and Inflammation (mean of last 2 Bath Ankylosing Spondylitis Disease Activity Index questions on morning stiffness).
Eligibility Criteria
Criteria
Inclusion criteria:
- Participant with AS who participated and completed 12-week treatment in study DRI11073-NCT01061723.
Exclusion criteria:
-
Adverse event(s) having lead to treatment discontinuation in the DRI11073 study;
-
Event or laboratory abnormality observed at the last treatment visit of DRI11073 study that would have adversely affected participation of the participant in this study as per investigator judgment.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | United States | 08807 |
| 2 | Sanofi-Aventis Administrative Office | Macquarie Park | New South Wales | Australia | |
| 3 | Sanofi-Aventis Administrative Office | Wien | Austria | ||
| 4 | Sanofi-Aventis Administrative Office | Diegem | Belgium | ||
| 5 | Sanofi-Aventis Administrative Office | Laval | Canada | ||
| 6 | Sanofi-Aventis Administrative Office | Praha | Czechia | ||
| 7 | Sanofi-Aventis Administrative Office | Paris | France | ||
| 8 | Sanofi-Aventis Administrative Office | Budapest | Hungary | ||
| 9 | Sanofi-Aventis Administrative Office | Vilnius | Lithuania | ||
| 10 | Sanofi-Aventis Administrative Office | Gouda | Netherlands | ||
| 11 | Sanofi-Aventis Administrative Office | Warszawa | Poland | ||
| 12 | Sanofi-Aventis Administrative Office | Barcelona | Spain |
Sponsors and Collaborators
- Sanofi
- Regeneron Pharmaceuticals
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LTS11298
- 2010-019263-11
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 56 centers in 12 countries. A total of 224 participants were screened between 01 June 2010 and 03 June 2011. |
|---|---|
| Pre-assignment Detail | Of 224 screened participants, 223 participants were enrolled and treated. One participant withdrew consent before randomization. |
| Arm/Group Title | Sarilumab |
|---|---|
| Arm/Group Description | Sarilumab 150 mg subcutaneous (SC) injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first. |
| Period Title: Overall Study | |
| STARTED | 223 |
| COMPLETED | 0 |
| NOT COMPLETED | 223 |
Baseline Characteristics
| Arm/Group Title | Sarilumab |
|---|---|
| Arm/Group Description | Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first. |
| Overall Participants | 223 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
41.6
(11.3)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
63
28.3%
|
| Male |
160
71.7%
|
Outcome Measures
| Title | Percentage of Participants Experiencing Any Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and Treatment Discontinuation |
|---|---|
| Description | An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of the relationship to the investigational medicinal product (IMP). SAE was any untoward medical occurrence that at any dose resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the TEAE period (time from first dose of IMP up to the end of follow-up period). |
| Time Frame | Baseline up to the end of study (66 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on safety population defined as all participants who received at least one dose of the study treatment after signature of the informed consent. |
| Arm/Group Title | Sarilumab |
|---|---|
| Arm/Group Description | Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first. |
| Measure Participants | 223 |
| Any TEAE |
67.3
30.2%
|
| Any treatment-emergent SAE |
5.4
2.4%
|
| Any TEAE leading to treatment discontinuation |
8.1
3.6%
|
| Title | Percentage of Participants Who Achieved 20% Response in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) |
|---|---|
| Description | Treatment response for ASAS20 was defined as: Improvement of ≥ 20% and ≥ 1 unit on a 0 (least) to 10 (worst) numerical rating score (NRS) in at least 3 of the 4 ASAS improvement criteria (ASASIC) domains, and no worsening of ≥ 20% and ≥ 1 unit on 0-10 NRS in the remaining domain. The 4 domains included were participant's global disease activity assessment, total back pain, physical function (Bath Ankylosing Spondylitis Functional Index), and Inflammation (mean of last 2 Bath Ankylosing Spondylitis Disease Activity Index questions on morning stiffness). |
| Time Frame | Baseline up to the end of treatment (60 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on safety population. Number of participants analyzed=participants with ASAS20 assessment at specified time-points. Here 'n' signifies number of participants with available data for specified time-point. |
| Arm/Group Title | Sarilumab |
|---|---|
| Arm/Group Description | Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first. |
| Measure Participants | 218 |
| Week 0 (n=218) |
30.3
13.6%
|
| Week 12 (n=207) |
40.1
18%
|
| Week 24 (n=150) |
46.0
20.6%
|
| Week 36 (n=93) |
41.9
18.8%
|
| Week 48 (n=37) |
59.5
26.7%
|
| Week 60 (n=7) |
57.1
25.6%
|
Adverse Events
| Time Frame | All AEs were collected from signature of the informed consent form up to the final visit (Day 414) regardless of seriousness or relationship to investigational product | |
|---|---|---|
| Adverse Event Reporting Description | Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of IMP up to the end of follow-up period). | |
| Arm/Group Title | Sarilumab | |
| Arm/Group Description | Sarilumab 150 mg SC injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first. | |
All Cause Mortality |
||
| Sarilumab | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Sarilumab | ||
| Affected / at Risk (%) | # Events | |
| Total | 12/223 (5.4%) | |
| Gastrointestinal disorders | ||
| Crohn's disease | 1/223 (0.4%) | |
| Infections and infestations | ||
| Cellulitis | 1/223 (0.4%) | |
| Diverticulitis | 1/223 (0.4%) | |
| Gastroenteritis | 1/223 (0.4%) | |
| Laryngitis | 1/223 (0.4%) | |
| Investigations | ||
| Tuberculin test positive | 1/223 (0.4%) | |
| Musculoskeletal and connective tissue disorders | ||
| Ankylosing spondylitis | 1/223 (0.4%) | |
| Joint instability | 1/223 (0.4%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Thyroid cancer | 1/223 (0.4%) | |
| Thyroid neoplasm | 1/223 (0.4%) | |
| Renal and urinary disorders | ||
| Nephrolithiasis | 2/223 (0.9%) | |
| Skin and subcutaneous tissue disorders | ||
| Skin necrosis | 1/223 (0.4%) | |
Other (Not Including Serious) Adverse Events |
||
| Sarilumab | ||
| Affected / at Risk (%) | # Events | |
| Total | 62/223 (27.8%) | |
| Blood and lymphatic system disorders | ||
| Neutropenia | 21/223 (9.4%) | |
| Gastrointestinal disorders | ||
| Aphthous stomatitis | 12/223 (5.4%) | |
| General disorders | ||
| Injection site reaction | 14/223 (6.3%) | |
| Infections and infestations | ||
| Nasopharyngitis | 16/223 (7.2%) | |
| Upper respiratory tract infection | 13/223 (5.8%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
| Name/Title | Trial Transparency Team |
|---|---|
| Organization | Sanofi |
| Phone | |
| Contact-US@sanofi.com |
- LTS11298
- 2010-019263-11