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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016068-35 | EudraCT Number |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
Not provided
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Primary objective:
- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20)
Secondary objectives:
to demonstrate that Sarilumab was effective on:
to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS
The duration of participation in this study for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-weeks double-blind treatment period and 6-weeks safety follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (for sarilumab) weekly (qw) for 12 weeks. |
|
| Sarilumab 100 mg q2w | Experimental | Sarilumab 100 mg Subcutaneous (SC) injection alternating with placebo every other week (q2w) for 12 weeks. |
|
| Sarilumab 150 mg q2w | Experimental | Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. |
|
| Sarilumab 100 mg qw | Experimental | Sarilumab 100 mg SC injection qw for 12 weeks. |
|
| Sarilumab 200 mg q2w | Experimental | Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
|
| Sarilumab 150 mg qw | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarilumab | Drug | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12 | Clinical response to treatment for ASAS20 was assessed according to ASAS20 criteria. Treatment response for ASAS20 was defined as an improvement by a decrease of ≥20% and ≥1unit on a 0 (no pain) - 10 (most severe pain) numerical rating scale (NRS) in at least 3 of the 4 ASAS improvement criteria (ASAS-IC) domains: assessment of physical function (measured by Bath Ankylosing Spondylitis Functional Index [BASFI]), back pain (0-10 NRS), participant global assessment (0-10 NRS) and inflammation (measured as the mean of the last 2 Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] questions) and no worsening (increase in score) of ≥20% and ≥1 unit on a 0-10 NRS in the remaining 4th domain. | Baseline to Week 12 (Last Observation Carried Forward [LOCF]) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12 | Clinical response to treatment for ASAS40 was assessed according to ASAS40 criteria. Treatment response for ASAS40 was defined as an improvement by a decrease of ≥40% and ≥2 units on a 0 (no pain)-10 (most severe pain) NRS in at least 3 of the 4 ASAS-IC domains (participant global assessment, back pain, physical function and inflammation) and no worsening (increase in score) at all in the remaining 4th domain. |
Not provided
Inclusion criteria:
Diagnosis of AS according to the New York modified criteria
Participants must had an adequate trial of at least 2 different Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) taken for at least 2 weeks in each case and, on a stable dose for ≥2 weeks or be intolerant to NSAIDs
Participants must had active AS for ≥3 months before screening and active disease must be present at screening and at baseline; Active AS being defined by:
Participants treated with corticosteroid must be on a stable dose for ≥2 weeks prior to baseline
Participants treated with the Disease Modifying Anti-Rheumatic Drugs (DMARDs) hydroxychloroquine, sulfasalazine and methotrexate (MTX) must be on stable dose ≥12 weeks prior to baseline
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840006 | Birmingham | Alabama | 35205 | United States | ||
| Investigational Site Number 840033 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24550171 | Result | Sieper J, Braun J, Kay J, Badalamenti S, Radin AR, Jiao L, Fiore S, Momtahen T, Yancopoulos GD, Stahl N, Inman RD. Sarilumab for the treatment of ankylosing spondylitis: results of a Phase II, randomised, double-blind, placebo-controlled study (ALIGN). Ann Rheum Dis. 2015 Jun;74(6):1051-7. doi: 10.1136/annrheumdis-2013-204963. Epub 2014 Feb 18. |
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Participants were randomized in 1:1:1:1:1:1 ratio for Placebo and Sarilumab (100 mg weekly [qw]; 150 mg qw; 100 mg every other week [q2w]; 150 mg q2w and 200 mg q2w) with screening high-sensitivity C-Reactive Protein (hs-CRP) (≤1.5 mg/L or >1.5 mg/L) and region as stratification factors.
The study was conducted at 68 centers in Europe, Canada and the United States. A total of 563 participants were screened between 04 February 2010 and 24 February 2011. Of 563 participants, 301 were randomized and 300 were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (for sarilumab) qw for 12 weeks. |
| FG001 | Sarilumab 100 mg q2w | Sarilumab 100 mg subcutaneous (SC) injection alternating with placebo q2w for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Sarilumab 150 mg SC injection qw for 12 weeks.
|
|
| Placebo | Drug | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
|
| Baseline to Week 12 (LOCF) |
| Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12 | Participants were classified as having achieved ASAS partial remission if they had a value ≤ 2 units on a 0 -10 NRS in each of the 4 domains: (participant global assessment, back pain, physical function and inflammation) of the ASAS-IC. | Baseline to Week 12 (LOCF) |
| Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12 | ASDAS consists of five components: (Total back pain assessed by BASDAI question 2 on a 0 [no pain] - 10 [most severe pain] NRS, participant global of disease activity on a 0 [none] - 10 [severe] NRS, peripheral pain/swelling assessed by BASDAI question 3 on a 0 [none] - 10 [most severe pain] NRS, duration of morning stiffness assessed by BASDAI question 6 on a NRS from 0 [0 hour] - 10 [2 or more hours] and hs-CRP in mg/L). ASDAS score was calculated as follows: 0.121 x total back pain + 0.110 x participant global of disease activity + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(CRP + 1). The scores were categorized as: inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity (> 3.5). | Baseline, Week 12 (LOCF) |
| Change From Baseline in BASDAI Score at Week 12 | BASDAI comprises of a 0 (no pain) -10 (very severe pain) NRS, used to answer 6 questions (Q) related to symptoms of AS (fatigue/tiredness, neck, back or hip pain, pain / swelling in joints, discomfort in tender areas, morning stiffness duration and morning stiffness severity). The BASDAI total score was calculated by computing the mean of Q5 and Q6 and adding it to the sum of Q1 to Q4. This score was then divided by 5. BASDAI total score=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity. | Baseline, Week 12 (LOCF) |
| Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12 | The range of motion was measured by the BASMI (11-point scale) including chest expansion in cm. It composed of 5 clinical measurements associated with a score: tragus to wall distance, modified schober's test, lateral spinal flexion, intermalleolar distance and cervical rotation. BASMI score was calculated by dividing the total of the score by 5, and the score ranges from 0-10. Higher BASMI score indicates more severe limitation of movement. | Baseline, Week 12 (LOCF) |
| Change From Baseline in Magnetic Resonance Imaging (MRI) Score of the Spine Assessed by the Berlin Modification of the AS Spine MRI-active (ASspiMRI-a) Score at Week 12 | ASspiMRI-a scoring system was used on all MRIs to score the level of the disease. MRIs were obtained using 1.0 or 1.5 Tesla scanners and phased array coils. Sagittal images of the upper (C2 to T10) and lower (T8 to S1) spine were used using both T1 weighted spin echo and fat saturated Short Tau Inversion Recovery (STIR) sequences. Each vertebral body unit was given an activity score based on the amount of bone marrow edema or erosion. Both T1 and STIR sequences were analyzed for change. Total spine ASspiMRI-a score in the Berlin modification range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from baseline indicates an improvement from baseline. The higher the negative value the higher the reduction of inflammation. | Baseline, Week 12 |
| Percentage of Participants Who Achieved ASAS 5/6 Improvement Criteria at Week 12 | ASAS 5/6 responder had an improvement of 20% in 5 of 6 domains (physical function, back pain, participant global assessment, inflammation, spinal mobility and acute phase reactants) of ASAS-IC without deterioration in the 6th domain. Spinal mobility was assessed by the mean of the 5 BASMI scores on the 11-point scale (score ranges from 0-10) and the hs-CRP for the acute phase reactant. | Baseline to Week 12 (LOCF) |
| Change From Baseline in Chest Expansion at Week 12 | The difference between maximal inspiration and expiration to the nearest 0.1 cm was recorded. The best of 2 tries were recorded. | Baseline, Week 12 (LOCF) |
| Change From Baseline in Swollen Joint Index at Week 12 | 44 swollen joints were examined including sternal, clavicular, elbow, shoulder, wrist, knee, metacarpophalangian, interphalangian, metatarpophalangian and metatarsophalangeal joints. | Baseline, Week 12 (LOCF) |
| Change From Baseline in Hs-CRP at Week 12 | Participant's blood samples were collected at screening, baseline before dosing and at every visit to evaluate the level of hs-CRP. The hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation. | Baseline, Week 12 (LOCF) |
| Change From Baseline in ASAS Individual Components at Week 12 | ASAS consists of 4 individual components: Participant global assessment to assess the disease activity over the last week on a 0 (no pain) - 10 (severe pain) NRS; back pain which consist of the mean of the nocturnal back pain and the total back pain at every visit on a 0 (no pain) - 10 (most severe pain) NRS; inflammation measured as the mean of the last 2 BASDAI questions (intensity and duration of morning stiffness) and physical function measured as mean of 10 scores of BASFI at every visit on 0 (easy) -10 (impossible) NRS. Lower score corresponds to a better functioning. | Baseline, Week 12 (LOCF) |
| Anaheim |
| California |
| 92801 |
| United States |
| Investigational Site Number 840027 | Los Angeles | California | 90048 | United States |
| Investigational Site Number 840007 | San Diego | California | 92108 | United States |
| Investigational Site Number 840013 | San Francisco | California | 94143 | United States |
| Investigational Site Number 840017 | Upland | California | 91786 | United States |
| Investigational Site Number 840009 | Boca Raton | Florida | 33486 | United States |
| Investigational Site Number 840001 | Naples | Florida | 34102 | United States |
| Investigational Site Number 840032 | Orlando | Florida | 32806 | United States |
| Investigational Site Number 840015 | Boise | Idaho | 83702 | United States |
| Investigational Site Number 840021 | Rock Island | Illinois | 61201 | United States |
| Investigational Site Number 840018 | Kansas City | Kansas | 66160-7321 | United States |
| Investigational Site Number 840003 | Wheaton | Maryland | 20902 | United States |
| Investigational Site Number 840029 | Worcester | Massachusetts | 01655 | United States |
| Investigational Site Number 840008 | Lansing | Michigan | 48823 | United States |
| Investigational Site Number 840002 | St Louis | Missouri | 63141 | United States |
| Investigational Site Number 840028 | Freehold | New Jersey | 07728 | United States |
| Investigational Site Number 840016 | Albany | New York | 12206 | United States |
| Investigational Site Number 840036 | Syracuse | New York | 13210 | United States |
| Investigational Site Number 840010 | Toledo | Ohio | 43606 | United States |
| Investigational Site Number 840005 | Oklahoma City | Oklahoma | 73109 | United States |
| Investigational Site Number 840023 | Bethlehem | Pennsylvania | 18015 | United States |
| Investigational Site Number 840014 | Duncansville | Pennsylvania | 16635 | United States |
| Investigational Site Number 840004 | Dallas | Texas | 75231 | United States |
| Investigational Site Number 840030 | Houston | Texas | 77034 | United States |
| Investigational Site Number 840034 | Chesapeake | Virginia | 23320 | United States |
| Investigational Site Number 036003 | Hobart | 7001 | Australia |
| Investigational Site Number 036001 | Malvern East | 3145 | Australia |
| Investigational Site Number 036004 | Shenton Park | 6008 | Australia |
| Investigational Site Number 036002 | Woolloongabba | 4102 | Australia |
| Investigational Site Number 040001 | Graz | 8036 | Austria |
| Investigational Site Number 040002 | Vienna | 1100 | Austria |
| Investigational Site Number 056003 | Brussels | 1020 | Belgium |
| Investigational Site Number 056005 | Genk | 3600 | Belgium |
| Investigational Site Number 056001 | Ghent | 9000 | Belgium |
| Investigational Site Number 056002 | Leuven | 3000 | Belgium |
| Investigational Site Number 056004 | Liège | 4000 | Belgium |
| Investigational Site Number 124007 | London | N6A 4V2 | Canada |
| Investigational Site Number 124004 | Montreal | H2L 1S6 | Canada |
| Investigational Site Number 124008 | Newmarket | L3Y 3R7 | Canada |
| Investigational Site Number 124003 | Pointe-Claire | H9R 3Z2 | Canada |
| Investigational Site Number 124001 | Québec | G1V 4R4 | Canada |
| Investigational Site Number 124006 | Saskatoon | S7K 0H6 | Canada |
| Investigational Site Number 124005 | Toronto | M5T 2S8 | Canada |
| Investigational Site Number 124009 | Trois-Rivières | G8Z 1Y2 | Canada |
| Investigational Site Number 124002 | Vancouver | V5Z 1L7 | Canada |
| Investigational Site Number 124010 | Vancouver | V5Z 3Y1 | Canada |
| Investigational Site Number 203003 | Brno | 63800 | Czechia |
| Investigational Site Number 203005 | Hlučín | 74801 | Czechia |
| Investigational Site Number 203002 | Hradec Králové | 50005 | Czechia |
| Investigational Site Number 203001 | Prague | 12850 | Czechia |
| Investigational Site Number 203004 | Uherské Hradiště | 68601 | Czechia |
| Investigational Site Number 250001 | Besançon | 25030 | France |
| Investigational Site Number 250005 | Bordeaux | 33076 | France |
| Investigational Site Number 250002 | Créteil | 94010 | France |
| Investigational Site Number 250003 | Paris | 75014 | France |
| Investigational Site Number 276002 | Berlin | 12200 | Germany |
| Investigational Site Number 276004 | Erlangen | 91054 | Germany |
| Investigational Site Number 276003 | Frankfurt am Main | 60590 | Germany |
| Investigational Site Number 276005 | Hamburg | 22081 | Germany |
| Investigational Site Number 276001 | Herne | 44652 | Germany |
| Investigational Site Number 348001 | Budapest | 1023 | Hungary |
| Investigational Site Number 348003 | Debrecen | 4032 | Hungary |
| Investigational Site Number 348005 | Sátoraljaújhely | 3980 | Hungary |
| Investigational Site Number 348004 | Veszprém | 8200 | Hungary |
| Investigational Site Number 440001 | Kaunas | LT-50009 | Lithuania |
| Investigational Site Number 440002 | Vilnius | LT-08661 | Lithuania |
| Investigational Site Number 528001 | Amsterdam | 1105 AZ | Netherlands |
| Investigational Site Number 528002 | Nijmegen | 6525 GA | Netherlands |
| Investigational Site Number 616002 | Bialystok | 15-354 | Poland |
| Investigational Site Number 616001 | Krakow | 30-510 | Poland |
| Investigational Site Number 616004 | Lublin | 20-607 | Poland |
| Investigational Site Number 616005 | Torun | 87-100 | Poland |
| Investigational Site Number 616003 | Warsaw | 02-637 | Poland |
| Investigational Site Number 724004 | A Coruña | 15006 | Spain |
| Investigational Site Number 724005 | Barcelona | 08907 | Spain |
| Investigational Site Number 724002 | Madrid | 28007 | Spain |
| Investigational Site Number 724001 | Seville | 41008 | Spain |
| Investigational Site Number 792002 | Ankara | 06100 | Turkey (Türkiye) |
| Investigational Site Number 792001 | Izmir | 35340 | Turkey (Türkiye) |
| FG002 | Sarilumab 150 mg q2w | Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. |
| FG003 | Sarilumab 100 mg qw | Sarilumab 100 mg SC injection qw for 12 weeks. |
| FG004 | Sarilumab 200 mg q2w | Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
| FG005 | Sarilumab 150 mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (for sarilumab) qw for 12 weeks. |
| BG001 | Sarilumab 100 mg q2w | Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks. |
| BG002 | Sarilumab 150 mg q2w | Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. |
| BG003 | Sarilumab 100 mg qw | Sarilumab 100 mg SC injection qw for 12 weeks. |
| BG004 | Sarilumab 200 mg q2w | Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
| BG005 | Sarilumab 150 mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12 | Clinical response to treatment for ASAS20 was assessed according to ASAS20 criteria. Treatment response for ASAS20 was defined as an improvement by a decrease of ≥20% and ≥1unit on a 0 (no pain) - 10 (most severe pain) numerical rating scale (NRS) in at least 3 of the 4 ASAS improvement criteria (ASAS-IC) domains: assessment of physical function (measured by Bath Ankylosing Spondylitis Functional Index [BASFI]), back pain (0-10 NRS), participant global assessment (0-10 NRS) and inflammation (measured as the mean of the last 2 Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] questions) and no worsening (increase in score) of ≥20% and ≥1 unit on a 0-10 NRS in the remaining 4th domain. | Intent-to-treat (ITT) population included all randomized participants. Missing data was imputed using LOCF. | Posted | Number | percentage of participants | Baseline to Week 12 (Last Observation Carried Forward [LOCF]) |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12 | Clinical response to treatment for ASAS40 was assessed according to ASAS40 criteria. Treatment response for ASAS40 was defined as an improvement by a decrease of ≥40% and ≥2 units on a 0 (no pain)-10 (most severe pain) NRS in at least 3 of the 4 ASAS-IC domains (participant global assessment, back pain, physical function and inflammation) and no worsening (increase in score) at all in the remaining 4th domain. | ITT population. Missing data was imputed using LOCF. | Posted | Number | percentage of participants | Baseline to Week 12 (LOCF) |
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| Secondary | Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12 | Participants were classified as having achieved ASAS partial remission if they had a value ≤ 2 units on a 0 -10 NRS in each of the 4 domains: (participant global assessment, back pain, physical function and inflammation) of the ASAS-IC. | ITT population. Missing data was imputed using LOCF. | Posted | Number | percentage of participants | Baseline to Week 12 (LOCF) |
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| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12 | ASDAS consists of five components: (Total back pain assessed by BASDAI question 2 on a 0 [no pain] - 10 [most severe pain] NRS, participant global of disease activity on a 0 [none] - 10 [severe] NRS, peripheral pain/swelling assessed by BASDAI question 3 on a 0 [none] - 10 [most severe pain] NRS, duration of morning stiffness assessed by BASDAI question 6 on a NRS from 0 [0 hour] - 10 [2 or more hours] and hs-CRP in mg/L). ASDAS score was calculated as follows: 0.121 x total back pain + 0.110 x participant global of disease activity + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(CRP + 1). The scores were categorized as: inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity (> 3.5). | ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with ASDAS score assessment at specified time-points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 (LOCF) |
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| Secondary | Change From Baseline in BASDAI Score at Week 12 | BASDAI comprises of a 0 (no pain) -10 (very severe pain) NRS, used to answer 6 questions (Q) related to symptoms of AS (fatigue/tiredness, neck, back or hip pain, pain / swelling in joints, discomfort in tender areas, morning stiffness duration and morning stiffness severity). The BASDAI total score was calculated by computing the mean of Q5 and Q6 and adding it to the sum of Q1 to Q4. This score was then divided by 5. BASDAI total score=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity. | ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with BASDAI score assessment at specified time-points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 (LOCF) |
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| Secondary | Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12 | The range of motion was measured by the BASMI (11-point scale) including chest expansion in cm. It composed of 5 clinical measurements associated with a score: tragus to wall distance, modified schober's test, lateral spinal flexion, intermalleolar distance and cervical rotation. BASMI score was calculated by dividing the total of the score by 5, and the score ranges from 0-10. Higher BASMI score indicates more severe limitation of movement. | ITT population. Missing data was imputed using LOCF. Number of participants analyzed=participants with BASMI score assessment at specified time-points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 (LOCF) |
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| Secondary | Change From Baseline in Magnetic Resonance Imaging (MRI) Score of the Spine Assessed by the Berlin Modification of the AS Spine MRI-active (ASspiMRI-a) Score at Week 12 | ASspiMRI-a scoring system was used on all MRIs to score the level of the disease. MRIs were obtained using 1.0 or 1.5 Tesla scanners and phased array coils. Sagittal images of the upper (C2 to T10) and lower (T8 to S1) spine were used using both T1 weighted spin echo and fat saturated Short Tau Inversion Recovery (STIR) sequences. Each vertebral body unit was given an activity score based on the amount of bone marrow edema or erosion. Both T1 and STIR sequences were analyzed for change. Total spine ASspiMRI-a score in the Berlin modification range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from baseline indicates an improvement from baseline. The higher the negative value the higher the reduction of inflammation. | ITT population. Number of participants analyzed = participants with ASspiMRI-a assessment at specified time-points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
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| Secondary | Percentage of Participants Who Achieved ASAS 5/6 Improvement Criteria at Week 12 | ASAS 5/6 responder had an improvement of 20% in 5 of 6 domains (physical function, back pain, participant global assessment, inflammation, spinal mobility and acute phase reactants) of ASAS-IC without deterioration in the 6th domain. Spinal mobility was assessed by the mean of the 5 BASMI scores on the 11-point scale (score ranges from 0-10) and the hs-CRP for the acute phase reactant. | ITT population. Missing data was imputed using LOCF. | Posted | Number | percentage of participants | Baseline to Week 12 (LOCF) |
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| Secondary | Change From Baseline in Chest Expansion at Week 12 | The difference between maximal inspiration and expiration to the nearest 0.1 cm was recorded. The best of 2 tries were recorded. | ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with chest expansion assessment at specified time-points. | Posted | Mean | Standard Deviation | cm | Baseline, Week 12 (LOCF) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Swollen Joint Index at Week 12 | 44 swollen joints were examined including sternal, clavicular, elbow, shoulder, wrist, knee, metacarpophalangian, interphalangian, metatarpophalangian and metatarsophalangeal joints. | ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with swollen joint count assessment at specified time-points. | Posted | Mean | Standard Deviation | Joints | Baseline, Week 12 (LOCF) |
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| Secondary | Change From Baseline in Hs-CRP at Week 12 | Participant's blood samples were collected at screening, baseline before dosing and at every visit to evaluate the level of hs-CRP. The hs-CRP is a protein marker in the blood associated with inflammation with higher values indicating a greater degree of inflammation. | ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with Hs-CRP assessment at specified time-points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Week 12 (LOCF) |
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| Secondary | Change From Baseline in ASAS Individual Components at Week 12 | ASAS consists of 4 individual components: Participant global assessment to assess the disease activity over the last week on a 0 (no pain) - 10 (severe pain) NRS; back pain which consist of the mean of the nocturnal back pain and the total back pain at every visit on a 0 (no pain) - 10 (most severe pain) NRS; inflammation measured as the mean of the last 2 BASDAI questions (intensity and duration of morning stiffness) and physical function measured as mean of 10 scores of BASFI at every visit on 0 (easy) -10 (impossible) NRS. Lower score corresponds to a better functioning. | ITT population. Missing data was imputed using LOCF. Number of participants analyzed = participants with ASAS assessment at specified time-points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 (LOCF) |
|
All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 18) regardless of seriousness or relationship to investigational product
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during 'on treatment period' (time from first dose injection of double-blind study to end of 6-week follow-up period). Safety population included all randomized participants who received at least one dose of the study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo (for sarilumab) qw for 12 weeks. | 0 | 50 | 7 | 50 | ||
| EG001 | SAR153191 100 mg q2w | Sarilumab 100 mg SC injection alternating with placebo q2w for 12 weeks. | 1 | 49 | 18 | 49 | ||
| EG002 | SAR153191 150 mg q2w | Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. Included a participant randomized to sarilumab 200 mg q2w who received sarilumab 150 mg q2w in error. | 4 | 51 | 23 | 51 | ||
| EG003 | SAR153191 100 mg qw | Sarilumab 100 mg SC injection qw for 12 weeks. | 1 | 52 | 22 | 52 | ||
| EG004 | SAR153191 200 mg q2w | Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. Excluded a participant randomized to sarilumab 200 mg q2w who received sarilumab 150 mg q2w in error. | 0 | 49 | 19 | 49 | ||
| EG005 | SAR153191 150 mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. | 1 | 49 | 22 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Helicobacter gastritis | Infections and infestations | MedDra 14.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 14.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDra 14.0 | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDra 14.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDra 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDra 14.0 | Systematic Assessment |
| |
| False positive tuberculosis test | Investigations | MedDra 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDra 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDra 14.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDra 14.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDra 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDra 14.0 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDra 14.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDra 14.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDra 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDra 14.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDra 14.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDra 14.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDra 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDra 14.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDra 14.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDra 14.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592401 | sarilumab |
Not provided
Not provided
Not provided
| Male |
|
| Cochran-Mantel-Haenszel |
| 0.467 |
Threshold for significance = 0.05 |
| Odds Ratio (OR) |
| 1.4 |
| 2-Sided |
| 95 |
| 0.6 |
| 3.5 |
| Superiority or Other |
| Cochran-Mantel-Haenszel | 0.559 | Threshold for significance = 0.05 | Odds Ratio (OR) | 0.8 | 2-Sided | 95 | 0.3 | 1.9 | Superiority or Other |
| Cochran-Mantel-Haenszel | 0.496 | Threshold for significance = 0.05 | Odds Ratio (OR) | 1.4 | 2-Sided | 95 | 0.6 | 3.4 | Superiority or Other |
| Cochran-Mantel-Haenszel | 0.143 | Threshold for significance = 0.05 | Odds Ratio (OR) | 1.8 | 2-Sided | 95 | 0.8 | 4.2 | Superiority or Other |
Sarilumab 100 mg SC injection qw for 12 weeks.
| OG004 | Sarilumab 200 mg q2w | Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
| OG005 | Sarilumab 150 mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. |
|
|
| OG004 |
| Sarilumab 200 mg q2w |
Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
| OG005 | Sarilumab 150 mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. |
|
|
Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. |
| OG003 | Sarilumab 100 mg qw | Sarilumab 100 mg SC injection qw for 12 weeks. |
| OG004 | Sarilumab 200 mg q2w | Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
| OG005 | Sarilumab 150 mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. |
|
|
| OG003 | Sarilumab 100 mg qw | Sarilumab 100 mg SC injection qw for 12 weeks. |
| OG004 | Sarilumab 200 mg q2w | Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
| OG005 | Sarilumab 150 mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. |
|
|
| Sarilumab 100 mg qw |
Sarilumab 100 mg SC injection qw for 12 weeks. |
| OG004 | Sarilumab 200 mg q2w | Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
| OG005 | Sarilumab 150 mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. |
|
|
| Sarilumab 150 mg q2w |
Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. |
| OG003 | Sarilumab 100 mg qw | Sarilumab 100 mg SC injection qw for 12 weeks. |
| OG004 | Sarilumab 200 mg q2w | Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
| OG005 | Sarilumab 150 mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. |
|
|
| OG004 | Sarilumab 200 mg q2w | Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
| OG005 | Sarilumab 150 mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. |
|
|
Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
| OG005 | Sarilumab 150 mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. |
|
|
| Sarilumab 200 mg q2w |
Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
| OG005 | Sarilumab 150 mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. |
|
|
| OG004 | Sarilumab 200 mg q2w | Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
| OG005 | Sarilumab 150 mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. |
|
|
| OG003 | Sarilumab 100mg qw | Sarilumab 100 mg SC injection qw for 12 weeks. |
| OG004 | Sarilumab 200mg q2w | Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. |
| OG005 | Sarilumab 150mg qw | Sarilumab 150 mg SC injection qw for 12 weeks. |
|
|