A Phase 2 interventional study of Sarilumab and Placebo in Ankylosing Spondylitis, sponsored by Sanofi. Completed at 80 sites in 14 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-08.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
Primary objective:
Secondary objectives:
to demonstrate that Sarilumab was effective on:
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.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 301 is above the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Placebo (for sarilumab) weekly (qw) for 12 weeks.
Drug: Placebo
Sarilumab 100 mg Subcutaneous (SC) injection alternating with placebo every other week (q2w) for 12 weeks.
Drug: Sarilumab · Drug: Placebo
Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks.
Drug: Sarilumab · Drug: Placebo
Sarilumab 100 mg SC injection qw for 12 weeks.
Drug: Sarilumab
Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks.
Drug: Sarilumab · Drug: Placebo
Sarilumab 150 mg SC injection qw for 12 weeks.
Drug: Sarilumab
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Also known as: SAR153191, REGN88
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
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.
Time frame: Baseline to Week 12 (Last Observation Carried Forward [LOCF])
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 12 (LOCF)
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.
| Milestone | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw |
|---|---|---|---|---|---|---|
| Started | 50 | 49 | 50 | 52 | 50 | 50 |
| Treated | 50 | 49 | 50 | 52 | 50 | 49 |
| Completed | 46 | 43 | 40 | 44 | 47 | 41 |
| Not completed | 4 | 6 | 10 | 8 | 3 | 9 |
| Withdrew: Adverse event | 0 | 2 | 5 | 5 | 2 | 6 |
| Withdrew: Lack of efficacy | 2 | 3 | 4 | 2 | 1 | 1 |
| Withdrew: Randomized but not treated | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Other than specified above | 2 | 1 | 1 | 1 | 0 | 1 |
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.
| percentage of participants | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw |
|---|---|---|---|---|---|---|
| Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12 | 24.0 | 24.5 | 30.0 | 19.2 | 30.0 | 38.0 |
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.
| percentage of participants | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw |
|---|---|---|---|---|---|---|
| Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12 | 8.0 | 14.3 | 16.0 | 5.8 | 18.0 | 20.0 |
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.
| percentage of participants | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw |
|---|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12 | 2.0 | 8.2 | 2.0 | 1.9 | 2.0 | 8.0 |
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).
| units on a scale | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw |
|---|---|---|---|---|---|---|
| Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12 | -0.4 ± 0.7 | -0.5 ± 0.9 | -0.8 ± 1.2 | -1.1 ± 0.8 | -1.2 ± 0.9 | -1.6 ± 0.9 |
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.
| units on a scale | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw |
|---|---|---|---|---|---|---|
| Change From Baseline in BASDAI Score at Week 12 | -0.9 ± 1.7 | -0.8 ± 1.9 | -1.1 ± 2.0 | -0.4 ± 1.4 | -0.9 ± 1.8 | -1.2 ± 1.8 |
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.
| units on a scale | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw |
|---|---|---|---|---|---|---|
| Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12 | -0.2 ± 0.8 | -0.2 ± 0.9 | -0.2 ± 0.8 | -0.4 ± 0.9 | -0.1 ± 0.8 | -0.2 ± 0.7 |
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.
| units on a scale | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw |
|---|---|---|---|---|---|---|
| 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 | -0.5 ± 2.2 | -0.5 ± 1.8 | -0.1 ± 3.4 | 0.1 ± 2.4 | -0.3 ± 3.3 | 0.3 ± 3.3 |
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.
| percentage of participants | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw |
|---|---|---|---|---|---|---|
| Percentage of Participants Who Achieved ASAS 5/6 Improvement Criteria at Week 12 | 6.0 | 12.2 | 10.0 | 13.5 | 14.0 | 32.0 |
The difference between maximal inspiration and expiration to the nearest 0.1 cm was recorded. The best of 2 tries were recorded.
| cm | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw |
|---|---|---|---|---|---|---|
| Change From Baseline in Chest Expansion at Week 12 | 0.2 ± 1.0 | 0.2 ± 1.2 | 0.0 ± 1.2 | -0.1 ± 0.9 | 0.1 ± 1.3 | 0.3 ± 1.3 |
44 swollen joints were examined including sternal, clavicular, elbow, shoulder, wrist, knee, metacarpophalangian, interphalangian, metatarpophalangian and metatarsophalangeal joints.
| Joints | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw |
|---|---|---|---|---|---|---|
| Change From Baseline in Swollen Joint Index at Week 12 | -0.4 ± 1.1 | -0.8 ± 3.1 | -0.3 ± 1.9 | -0.3 ± 2.4 | -0.4 ± 1.6 | -0.2 ± 7.3 |
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.
| mg/dL | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw |
|---|---|---|---|---|---|---|
| Change From Baseline in Hs-CRP at Week 12 | -3.7 ± 19.1 | -1.2 ± 17.9 | -5.8 ± 27.6 | -13.5 ± 20.3 | -11.5 ± 17.5 | -14.3 ± 15.3 |
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.
| units on a scale | Placebo | Sarilumab 100mg q2w | Sarilumab 150mg q2w | Sarilumab 100mg qw | Sarilumab 200mg q2w | Sarilumab 150mg qw |
|---|---|---|---|---|---|---|
| Participant global assessment | -1.0 ± 1.9 | -1.1 ± 2.3 | -0.8 ± 2.3 | -0.4 ± 2.2 | -0.9 ± 2.2 | -1.6 ± 2.0 |
| Back pain | -0.8 ± 1.8 | -1.3 ± 2.2 | -1.2 ± 2.4 | -0.5 ± 1.8 | -0.9 ± 2.2 | -1.6 ± 2.1 |
| Inflammation | -1.4 ± 1.8 | -0.8 ± 2.0 | -1.1 ± 2.0 | -0.7 ± 2.1 | -1.0 ± 1.9 | -1.8 ± 2.3 |
| Physical function | -0.6 ± 1.2 | -0.5 ± 1.7 | -0.4 ± 2.0 | -0.1 ± 1.4 | -0.6 ± 1.9 | -1.1 ± 1.9 |
Collected over 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. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/50 (0%) | 7/50 (14%) |
| SAR153191 100 mg q2w | — | 1/49 (2%) | 18/49 (36.7%) |
| SAR153191 150 mg q2w | — | 4/51 (7.8%) | 23/51 (45.1%) |
| SAR153191 100 mg qw | — | 1/52 (1.9%) | 22/52 (42.3%) |
| SAR153191 200 mg q2w | — | 0/49 (0%) | 19/49 (38.8%) |
| SAR153191 150 mg qw | — | 1/49 (2%) | 22/49 (44.9%) |
| Event | Placebo | SAR153191 100 mg q2w | SAR153191 150 mg q2w | SAR153191 100 mg qw | SAR153191 200 mg q2w | SAR153191 150 mg qw |
|---|---|---|---|---|---|---|
| EpilepsyNervous system disorders | 0/50 | 1/49 | 0/51 | 0/52 | 0/49 | 0/49 |
| False positive tuberculosis testInvestigations | 0/50 | 0/49 | 0/51 | 0/52 | 0/49 | 1/49 |
| NeutropeniaBlood and lymphatic system disorders | 0/50 | 0/49 | 1/51 | 0/52 | 0/49 | 0/49 |
| Myocardial ischemiaCardiac disorders | 0/50 | 0/49 | 1/51 | 0/52 | 0/49 | 0/49 |
| PainGeneral disorders | 0/50 | 0/49 | 1/51 | 0/52 | 0/49 | 0/49 |
| Alanine aminotransferase increasedInvestigations | 0/50 | 0/49 | 1/51 | 0/52 | 0/49 | 0/49 |
| Helicobacter gastritisInfections and infestations | 0/50 | 0/49 | 0/51 | 1/52 | 0/49 | 0/49 |
| Event | Placebo | SAR153191 100 mg q2w | SAR153191 150 mg q2w | SAR153191 100 mg qw | SAR153191 200 mg q2w | SAR153191 150 mg qw |
|---|---|---|---|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 0/50 | 0/49 | 6/51 | 2/52 | 4/49 | 8/49 |
| Upper respiratory tract infectionInfections and infestations | 4/50 | 1/49 | 2/51 | 7/52 | 3/49 | 4/49 |
| DiarrheaGastrointestinal disorders | 1/50 | 2/49 | 5/51 | 0/52 | 2/49 | 0/49 |
| HeadacheNervous system disorders | 0/50 | 4/49 | 2/51 | 0/52 | 2/49 | 1/49 |
| Alanine aminotransferase increasedInvestigations | 0/50 | 0/49 | 0/51 | 4/52 | 4/49 | 1/49 |
| NasopharyngitisInfections and infestations | 1/50 | 2/49 | 2/51 | 1/52 | 2/49 | 3/49 |
| Abdominal painGastrointestinal disorders | 0/50 | 3/49 | 3/51 | 1/52 | 0/49 | 0/49 |
| Aphthous stomatitisGastrointestinal disorders | 1/50 | 3/49 | 3/51 | 2/52 | 3/49 | 1/49 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 0/50 | 1/49 | 0/51 | 0/52 | 3/49 | 1/49 |
| FatigueGeneral disorders | 0/50 | 3/49 | 2/51 | 0/52 | 0/49 | 0/49 |
| Age, Continuous(years) | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw | Total |
|---|---|---|---|---|---|---|---|
| Mean | 40.3 ± 11.7 | 42.4 ± 10.8 | 43.0 ± 11.3 | 40.4 ± 11.5 | 37.2 ± 10.4 | 41.1 ± 11.1 | 40.7 ± 11.2 |
| Sex: Female, Male(Participants) | Placebo | Sarilumab 100 mg q2w | Sarilumab 150 mg q2w | Sarilumab 100 mg qw | Sarilumab 200 mg q2w | Sarilumab 150 mg qw | Total |
|---|---|---|---|---|---|---|---|
| Female | 12 | 19 | 16 | 15 | 10 | 11 | 83 |
| Male | 38 | 30 | 34 | 37 | 40 | 39 | 218 |
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