A Phase 2 interventional study of secukinumab (AIN457) and placebo in Rheumatoid Arthritis, sponsored by Novartis Pharmaceuticals. Completed at 39 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-02.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
The study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis (RA) despite treatment with Methotrexate.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 221 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
Biological: secukinumab (AIN457) · Drug: placebo
secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
Biological: secukinumab (AIN457) · Drug: placebo
placebo at Weeks 0, 1, 2, 3, 4, 8 \& 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
Biological: secukinumab (AIN457) · Drug: placebo
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
Matching placebo to AIN457 i.v. and to AIN457 s.c..
Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20)
A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).
Time frame: 12 weeks
Percentage of Participants Who Achieve ACR50 and ACR70
A participant was considered to be a responder according to the ACR50 or ACR70 criteria if the participant had at least 50% or 70% improvement, respectively, in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).
Time frame: 12 weeks
Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score.
The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.
Time frame: baseline, 12 Weeks
Change From Baseline in DAS28 Using High Sensitivity C-reactive Protein (hsCRP) (DAS28-CRP)
The Disease Activity Score (DAS) is a combined index to measure disease activity in RA participants. DAS28-CRP is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) or global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 = and 100 = ). Using the data from these variables, DAS28-CRP is calculated using the following formula: DAS28-4(crp) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96. The calculation results in a DAS28-CRP score from 0 to 10 indicating the current activity of the rheumatoid arthritis of your patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. A negative change from baseline indicates improvement.
Time frame: baseline, 12 weeks
Change From Baseline in Disease Activity Score 28 Response Using ESR (DAS28-ESR)
The Disease Activity Score (DAS) is a combined index to measure disease activity in RA participants. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), erythrocyte sedimentation rate (ESR), and the participant's general health (GH) or global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 = and 100 = ). Using the data from these variables, DAS28-ESR is calculated using the following formula: DAS28 = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.70 \* ln(ESR) + 0.014 \* GH. The calculation results in a DAS28-ESR score from 0 to 10 indicating the current activity of the rheumatoid arthritis of your patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. A negative change from baseline indicates improvement.
Time frame: baseline, 12 weeks
Percentage of Participants With European League Against Rheumatism (EULAR) Response
EULAR response criteria are based on DAS28 status in combination with DAS28 improvements. The EULAR response criteria are as follows: present DAS28 \<3.2 with DAS28 improvement \>1.2 corresponds to 'good response'; present DAS28 \<3.2 with DAS28 improvement between 0.6 to 1.2, or present DAS28 between 3.2 to 5.1 with DAS28 improvement from 0.6 to \>1.2, or present DAS28 \>5.2 with DAS28 improvement \>1.2 correspond to 'moderate response; present DAS28 \<3.2 with DAS28 improvement \<0.6, or present DAS28 between 3.2 to 5.1 with DAS28 improvement \<0.6, or present DAS28 \>5.1 with DAS28 improvement \<0.6 to 1.2 correspond to 'no response'.
Time frame: baseline, 12 weeks
Change From Baseline in Swollen 66-joint Count
The 66 joints assessed for swelling included the 8 distal interphalangeal, 10 proximal interphalangeal and 10 metacarpophalangeal joints of the hands, the 10 metatarsophalangeal and 10 proximal interphalangeal joints of the feet, the 2 wrists, 2 elbows , 2 shoulders , 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Swelling was graded present (1) or absent (0). A negative change in baseline indicates improvement.
Time frame: baseline, 12 weeks
Change From Baseline in Tender 68-joint Count
The 68 joints assessed for tenderness included the 8 distal interphalangeal, 10 proximal interphalangeal and 10 metacarpophalangeal joints of the hands, the 10 metatarsophalangeal and 10 proximal interphalangeal joints of the feet, the 2 wrists, 2 elbows , 2 shoulders , 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 hip, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Joint tenderness was graded present (1) or absent (0). A negative change from baseline indicates improvement.
Time frame: baseline, 12 weeks
Change From Baseline in Participant's Assessment of Rheumatoid Arthritis (RA) Pain
The patient's assessment of pain was performed using 100 mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (unbearable pain) after the question "Please indicate with a vertical mark through the horizontal line the most pain you had from your rheumatoid arthritis over the last 24 hours". A negative change from baseline indicates improvement.
Time frame: baseline, 12 weeks
Change From Baseline in Participant's Global Assessment of Disease Activity
The patient's global assessment of disease activity was performed using 100 mm VAS ranging from 0 (very good) to 100 (very poor), after the question "Considering all the ways rheumatoid arthritis affects you, please indicate with a vertical mark through the horizontal line how well you are doing today". A negative change from baseline indicates improvement.
Time frame: baseline, 12 weeks
Change From Baseline in Physician's Global Assessment of Disease Activity
The physician's global assessment of disease activity was performed using 100 mm VAS ranging from 0 (very good) to 100 (very poor), after the question "Considering all the ways rheumatoid arthritis affects your patient, how would you rate his or her current condition?". A negative change from baseline indicates improvement.
Time frame: baseline, 12 weeks
Change From Baseline in hsCRP
Blood for this assessment was obtained to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.
Time frame: baseline, 12 weeks
Change From Baseline in ESR
Blood for this assessment was obtained to monitor disease activity and response to therapy. A negative change from baseline indicates improvement.
Time frame: baseline, 12 weeks
Participants were randomized to one of the following 3 treatment groups in a 2:2:1 ratio: secukinumab 10 mg/kg i.v., secukinumab 150 mg s.c. or placebo.
| Milestone | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Started | 88 | 89 | 44 |
| Completed | 86 | 85 | 44 |
| Not completed | 2 | 4 | 0 |
| Withdrew: Abnormal laboratory values | 1 | 0 | 0 |
| Withdrew: Adverse event | 1 | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 | 0 |
| Milestone | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Started | 86 | 84 | 44 |
| Completed | 78 | 71 | 36 |
| Not completed | 8 | 13 | 8 |
| Withdrew: Administrative problems | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 3 | 4 |
| Withdrew: Protocol deviation | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 3 | 3 | 3 |
| Withdrew: Abnormal laboratory values | 0 | 1 | 0 |
| Withdrew: Adverse event | 3 | 5 | 1 |
| Milestone | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Started | 86 | 84 | 44 |
| Completed | 78 | 69 | 36 |
| Not completed | 8 | 15 | 8 |
| Withdrew: Withdrawal by subject | 1 | 5 | 4 |
| Withdrew: Administrative problems | 1 | 0 | 0 |
| Withdrew: Protocol deviation | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 3 | 3 | 3 |
| Withdrew: Abnormal laboratory value | 0 | 1 | 0 |
| Withdrew: Adverse event | 3 | 5 | 1 |
A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).
| Percentage of participants | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20) | 53.4 | 44.9 | 40.9 |
A participant was considered to be a responder according to the ACR50 or ACR70 criteria if the participant had at least 50% or 70% improvement, respectively, in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).
| Percentage of participants | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| ACR50 | 20.5 | 18.0 | 11.4 |
| ACR70 | 8.0 | 5.6 | 0.0 |
The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.
| score on a scale | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score. | -0.35 ± 0.052 | -0.28 ± 0.053 | -0.17 ± 0.074 |
The Disease Activity Score (DAS) is a combined index to measure disease activity in RA participants. DAS28-CRP is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) or global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 = and 100 = ). Using the data from these variables, DAS28-CRP is calculated using the following formula: DAS28-4(crp) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH + 0.96. The calculation results in a DAS28-CRP score from 0 to 10 indicating the current activity of the rheumatoid arthritis of your patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. A negative change from baseline indicates improvement.
| score on a scale | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Change From Baseline in DAS28 Using High Sensitivity C-reactive Protein (hsCRP) (DAS28-CRP) | -1.67 ± 0.119 | -1.65 ± 0.120 | -1.21 ± 0.166 |
The Disease Activity Score (DAS) is a combined index to measure disease activity in RA participants. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), erythrocyte sedimentation rate (ESR), and the participant's general health (GH) or global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 = and 100 = ). Using the data from these variables, DAS28-ESR is calculated using the following formula: DAS28 = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.70 \* ln(ESR) + 0.014 \* GH. The calculation results in a DAS28-ESR score from 0 to 10 indicating the current activity of the rheumatoid arthritis of your patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. A negative change from baseline indicates improvement.
| score on a scale | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Change From Baseline in Disease Activity Score 28 Response Using ESR (DAS28-ESR) | -1.98 ± 0.126 | -1.80 ± 0.128 | -1.46 ± 0.179 |
EULAR response criteria are based on DAS28 status in combination with DAS28 improvements. The EULAR response criteria are as follows: present DAS28 \<3.2 with DAS28 improvement \>1.2 corresponds to 'good response'; present DAS28 \<3.2 with DAS28 improvement between 0.6 to 1.2, or present DAS28 between 3.2 to 5.1 with DAS28 improvement from 0.6 to \>1.2, or present DAS28 \>5.2 with DAS28 improvement \>1.2 correspond to 'moderate response; present DAS28 \<3.2 with DAS28 improvement \<0.6, or present DAS28 between 3.2 to 5.1 with DAS28 improvement \<0.6, or present DAS28 \>5.1 with DAS28 improvement \<0.6 to 1.2 correspond to 'no response'.
| Percentage of participants | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Good response | 28.4 | 27.0 | 13.6 |
| Moderate response | 46.6 | 44.9 | 52.3 |
| No response | 25.0 | 28.1 | 34.1 |
The 66 joints assessed for swelling included the 8 distal interphalangeal, 10 proximal interphalangeal and 10 metacarpophalangeal joints of the hands, the 10 metatarsophalangeal and 10 proximal interphalangeal joints of the feet, the 2 wrists, 2 elbows , 2 shoulders , 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Swelling was graded present (1) or absent (0). A negative change in baseline indicates improvement.
| Number of joints | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Change From Baseline in Swollen 66-joint Count | -9.49 ± 0.607 | -9.81 ± 0.612 | -7.88 ± 0.863 |
The 68 joints assessed for tenderness included the 8 distal interphalangeal, 10 proximal interphalangeal and 10 metacarpophalangeal joints of the hands, the 10 metatarsophalangeal and 10 proximal interphalangeal joints of the feet, the 2 wrists, 2 elbows , 2 shoulders , 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 hip, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Joint tenderness was graded present (1) or absent (0). A negative change from baseline indicates improvement.
| Number of joints | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Change From Baseline in Tender 68-joint Count | -10.31 ± 1.093 | -11.99 ± 1.099 | -9.50 ± 1.549 |
The patient's assessment of pain was performed using 100 mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (unbearable pain) after the question "Please indicate with a vertical mark through the horizontal line the most pain you had from your rheumatoid arthritis over the last 24 hours". A negative change from baseline indicates improvement.
| score on a scale | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Change From Baseline in Participant's Assessment of Rheumatoid Arthritis (RA) Pain | -14.41 ± 2.057 | -12.60 ± 2.071 | -6.66 ± 2.902 |
The patient's global assessment of disease activity was performed using 100 mm VAS ranging from 0 (very good) to 100 (very poor), after the question "Considering all the ways rheumatoid arthritis affects you, please indicate with a vertical mark through the horizontal line how well you are doing today". A negative change from baseline indicates improvement.
| score on a scale | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Change From Baseline in Participant's Global Assessment of Disease Activity | -18.58 ± 2.042 | -15.29 ± 2.063 | -9.93 ± 2.884 |
The physician's global assessment of disease activity was performed using 100 mm VAS ranging from 0 (very good) to 100 (very poor), after the question "Considering all the ways rheumatoid arthritis affects your patient, how would you rate his or her current condition?". A negative change from baseline indicates improvement.
| score on a scale | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Change From Baseline in Physician's Global Assessment of Disease Activity | -27.05 ± 1.925 | -29.01 ± 1.950 | 18.88 ± 2.726 |
Blood for this assessment was obtained to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.
| mg/L | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Change From Baseline in hsCRP | -6.00 ± 0.938 | -5.72 ± 0.946 | -1.69 ± 1.336 |
Blood for this assessment was obtained to monitor disease activity and response to therapy. A negative change from baseline indicates improvement.
| mm/hr | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo |
|---|---|---|---|
| Change From Baseline in ESR | -16.68 ± 1.409 | -12.43 ± 1.425 | -10.53 ± 1.993 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Secukinumab 10 mg/kg i.v. Loading | — | 2/88 (2.3%) | 17/88 (19.3%) |
| Secukinumab 150 mg s.c. Loading | — | 3/89 (3.4%) | 30/89 (33.7%) |
| Placebo | — | 1/44 (2.3%) | 18/44 (40.9%) |
| AIN457 Pooled Treatment Groups - Open Label Period | — | 18/214 (8.4%) | 78/214 (36.4%) |
| AIN457 Pooled Treatment Groups - Follow-up Period | — | 3/214 (1.4%) | 10/214 (4.7%) |
| Event | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo | AIN457 Pooled Treatment Groups - Open Label Period | AIN457 Pooled Treatment Groups - Follow-up Period |
|---|---|---|---|---|---|
| Myocardial infarctionCardiac disorders | 0/88 | 0/89 | 1/44 | 1/214 | 0/214 |
| Atrial fibrillationCardiac disorders | 1/88 | 0/89 | 0/44 | 0/214 | 0/214 |
| SciaticaNervous system disorders | 1/88 | 0/89 | 0/44 | 0/214 | 0/214 |
| Brain neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/88 | 1/89 | 0/44 | 0/214 | 0/214 |
| DepressionPsychiatric disorders | 0/88 | 1/89 | 0/44 | 0/214 | 0/214 |
| MetrorrhagiaReproductive system and breast disorders | 0/88 | 1/89 | 0/44 | 0/214 | 0/214 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 0/88 | 0/89 | 0/44 | 2/214 | 0/214 |
| AnaemiaBlood and lymphatic system disorders | 0/88 | 0/89 | 0/44 | 1/214 | 0/214 |
| Cardiac failureCardiac disorders | 0/88 | 0/89 | 0/44 | 1/214 | 0/214 |
| Abdominal painGastrointestinal disorders | 0/88 | 0/89 | 0/44 | 1/214 | 0/214 |
| Event | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo | AIN457 Pooled Treatment Groups - Open Label Period | AIN457 Pooled Treatment Groups - Follow-up Period |
|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 5/88 | 5/89 | 4/44 | 11/214 | 1/214 |
| Upper respiratory tract infectionInfections and infestations | 1/88 | 1/89 | 0/44 | 17/214 | 1/214 |
| Oral herpesInfections and infestations | 0/88 | 1/89 | 3/44 | 5/214 | 0/214 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 0/88 | 5/89 | 2/44 | 12/214 | 5/214 |
| HypertensionVascular disorders | 1/88 | 2/89 | 1/44 | 11/214 | 0/214 |
| RhinitisInfections and infestations | 2/88 | 0/89 | 2/44 | 3/214 | 0/214 |
| HypercholesterolaemiaMetabolism and nutrition disorders | 0/88 | 1/89 | 2/44 | 1/214 | 0/214 |
| HeadacheNervous system disorders | 2/88 | 4/89 | 1/44 | 5/214 | 0/214 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/88 | 1/89 | 0/44 | 7/214 | 0/214 |
| PharyngitisInfections and infestations | 0/88 | 1/89 | 0/44 | 6/214 | 1/214 |
| Age, Continuous(Years) | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo | Total |
|---|---|---|---|---|
| Mean | 53.8 ± 11.81 | 54.5 ± 12.26 | 53.5 ± 9.33 | 54.0 ± 11.51 |
| Sex: Female, Male(Participants) | Secukinumab 10 mg/kg i.v. Loading | Secukinumab 150 mg s.c. Loading | Placebo | Total |
|---|---|---|---|---|
| Female | 67 | 72 | 37 | 176 |
| Male | 21 | 17 | 7 | 45 |
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