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This study was designed to prove and quantify the hypothesis that secukinumab is effective, safe and well tolerated in the treatment of moderate to severe chronic plaque-type psoriasis in patients who are inadequate responders to anti-TNFα therapy in a United Kingdom (UK) and Republic of Ireland) specific population.
There is no clear evidence or guidelines on appropriate treatment once a patient with moderate/severe psoriasis has failed to respond to anti-TNFα therapy, whether a single anti-TNFα therapy failure or multiple anti-TNFα therapy failures.
Numerous double-blind, double-dummy, randomised, parallel-group, active and placebo controlled studies have already been designed and run for the Phase III secukinumab clinical development program, in accordance with Health Authorities guidelines and feedback, including Food and Drug Administration (FDA) and European Medicines Agency (EMA). None of these specifically studied patients who have failed to respond to anti-TNFα therapy as defined by National Institute for Health and Care Excellence (NICE) guidelines.
Therefore, this study utilises a pragmatic, open-label, non-comparator design, which has been shown to be appropriate in similar studies looking at anti-TNFα therapy in patients failing on other therapies (Papp et al. 2012; Strober et al. 2011), to answer the question of whether secukinumab is an appropriate choice in patients who have failed to respond to anti-TNFα therapy (TNF-IR) per NICE definitions, whether a single anti-TNFα therapy failure or multiple anti-TNFα therapy failures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab (AIN457) 300 mg | Experimental | Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. |
|
| Secukinumab (AIN457) 150 mg | Experimental | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab (AIN457) | Biological | Secukinumab was supplied in 150mg pre-filled syringes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Secukinumab 300 mg Participants Achieving PASI 75 at 16 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Secukinumab 150 mg Participants Achieving PASI 75 at 16 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. |
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Inclusion Criteria:
Written informed consent must be obtained before any assessment is performed
Aged at least 18 years at screening
Chronic plaque-type psoriasis diagnosed for at least 6 months prior to screening
Moderate to severe disease severity:
Failed to respond to systemic therapies including cyclosporine and/or methotrexate and/or PUVA (or is intolerant and/or has a contraindication to these)
Previously treated with at least one anti-TNFα for moderate or severe psoriasis but is a primary or secondary non-responder
Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Cork | T12 X23H | Ireland | |||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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For both maintenance periods 1 and 2, after 16 weeks and 48 weeks, respectively, responders at both the 150 mg and 300 mg doses continued on their initiation doses during maintenance periods 1 and 2. Non-responders at 150 mg were uptitrated to 300 mg. Non-responders at 300 mg returned to routine treatment under the care of their usual clinician.
This study consisted of 3 periods: initiation, maintenance 1 and maintenance 2. During the initiation period, participants received secukinumab 150 mg or 300 mg for 16 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab (AIN457) 300 mg | Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initiation |
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| 16 Weeks |
| Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. | 16 Weeks |
| Percentage of Participants Achieiving PASI 75 - Initiation Period | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. | 2 ,4, 8, 12 and 16 Weeks |
| Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. | 16, 24 and 48 Weeks |
| Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. | 48 and 72 Weeks |
| Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively. | 2, 4, 8, 12, 16 Weeks |
| Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively. | 16, 24 and 48 Weeks |
| Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively. | 48 and 72 Weeks |
| Percentage of Participants Who Have Failed on One Anti-TNFα Achieving PASI 75 (Subgroups 1 and 2 Combined) at 16 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. | 16 Weeks |
| Percentage of Participants Achieving NICE Continuation Criteria (PASI 75 or PASI 50 Plus a 5 Point Improvement in DLQI) at 16 Weeks | PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | 16 Weeks |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Scores - Initiation Period | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement. | Baseline, week 12, and week 16 |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement. | Baseline, 16, 24 and 48 weeks |
| Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement. | Baseline, 48 and 72 weeks |
| Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Initiation Period | The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. | Baseline, 12 and 16 weeks |
| Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period | The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. | Baseline, 16, 24 and 48 weeks |
| Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period | The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. | Baseline, 48 and 72 weeks |
| Dublin |
| 24 |
| Ireland |
| Novartis Investigative Site | Dublin | Ireland |
| Novartis Investigative Site | Plymouth | Devon | PL6 8DH | United Kingdom |
| Novartis Investigative Site | London | England | E11 1NR | United Kingdom |
| Novartis Investigative Site | Harlow | Essex | CM20 1QX | United Kingdom |
| Novartis Investigative Site | London | GBR | SW10 9NH | United Kingdom |
| Novartis Investigative Site | Canterbury | Kent | CT1 3NG | United Kingdom |
| Novartis Investigative Site | Dafen | Llanelli | SA14 8QF | United Kingdom |
| Novartis Investigative Site | Salford | Manchester | M6 8HD | United Kingdom |
| Novartis Investigative Site | Cliftonville | Northampton | NN1 5BD | United Kingdom |
| Novartis Investigative Site | Nottingham | Nottinghamshire | NG17 4JL | United Kingdom |
| Novartis Investigative Site | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Novartis Investigative Site | Yeovil | Somerset | BA21 4AT | United Kingdom |
| Novartis Investigative Site | Cardiff | South Glamorgan | CF4 4XW | United Kingdom |
| Novartis Investigative Site | Staffordshire | Staffordshire | WS11 5XY | United Kingdom |
| Novartis Investigative Site | Ipswich | Suffolk | IP4 5PD | United Kingdom |
| Novartis Investigative Site | Frimley | Surrey | GU16 7UJ | United Kingdom |
| Novartis Investigative Site | Surrey | Surrey | RH1 5RH | United Kingdom |
| Novartis Investigative Site | Rhyl | Wales | LL18 5UJ | United Kingdom |
| Novartis Investigative Site | Coventry | Warwickshire | CV2 2DX | United Kingdom |
| Novartis Investigative Site | Dudley | West Midlands | DY1 2HQ | United Kingdom |
| Novartis Investigative Site | Bradford | West Yorkshire | BD5 0NA | United Kingdom |
| Novartis Investigative Site | Leeds | West Yorkshire | LS7 4SA | United Kingdom |
| Novartis Investigative Site | Airdrie | ML6 0JS | United Kingdom |
| Novartis Investigative Site | Bath | BA1 3NG | United Kingdom |
| Novartis Investigative Site | Belfast | BT9 7AB | United Kingdom |
| Novartis Investigative Site | Birmingham | B15 2TT | United Kingdom |
| Novartis Investigative Site | Birmingham | B18 7QH | United Kingdom |
| Novartis Investigative Site | Chester | CH2 1UL | United Kingdom |
| Novartis Investigative Site | Durham | DH1 5TW | United Kingdom |
| Novartis Investigative Site | Fife | KY12 OSU | United Kingdom |
| Novartis Investigative Site | Glasgow | G3 8SJ | United Kingdom |
| Novartis Investigative Site | Hull | HU3 2JZ | United Kingdom |
| Novartis Investigative Site | Lancaster | LA1 4RP | United Kingdom |
| Novartis Investigative Site | Leicester | LE7 5WW | United Kingdom |
| Novartis Investigative Site | Liverpool | L14 3PE | United Kingdom |
| Novartis Investigative Site | London | N19 5NF | United Kingdom |
| Novartis Investigative Site | London | NW3 2QG | United Kingdom |
| Novartis Investigative Site | London | SE1 9RT | United Kingdom |
| Novartis Investigative Site | Middlesbrough | TS4 3BW | United Kingdom |
| Novartis Investigative Site | Middlesex | TW7 6AF | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Novartis Investigative Site | Norwich | NR4 7UY | United Kingdom |
| Novartis Investigative Site | Nottingham | NG7 2UH | United Kingdom |
| Novartis Investigative Site | Oxford | OX3 7LJ | United Kingdom |
| Novartis Investigative Site | Poole | BH15 2JB | United Kingdom |
| Novartis Investigative Site | Portsmouth | PO6 6AD | United Kingdom |
| Novartis Investigative Site | Scaroborough | YO12 6QL | United Kingdom |
| Novartis Investigative Site | Scunthorpe | DN15 7GB | United Kingdom |
| Novartis Investigative Site | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Novartis Investigative Site | Surrey | SM5 1AA | United Kingdom |
| Novartis Investigative Site | Wrexham | LL13 7TD | United Kingdom |
| Novartis Investigative Site | York | YO31 8HE | United Kingdom |
| FG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
| FG002 | Secukinumab (AIN457) 150 mg - 300 mg (Maintanence Period 1) | Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16. |
| FG003 | Secukinumab (AIN457) 150 mg - 300 mg (Maintenance Period 2) | Non-responders at secukinumab 150 mg from maintenance 1 period were uptitrated to secukinumab 300 mg at week 48. |
| Safety Set |
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| Full Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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| Maintenance 1 (Weeks 17 - 48) |
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| Maintanence 2 (Weeks 49 - 72) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab (AIN457) 300 mg | Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. |
| BG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Secukinumab 300 mg Participants Achieving PASI 75 at 16 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. | The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues). | Posted | Number | Percentage of participants | 16 weeks |
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| Secondary | Percentage of Secukinumab 150 mg Participants Achieving PASI 75 at 16 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. | The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues). | Posted | Number | Percentage of participants | 16 Weeks |
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| Secondary | Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. | The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues). | Posted | Number | Percentage of participants | 16 Weeks |
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| Secondary | Percentage of Participants Achieiving PASI 75 - Initiation Period | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. | The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues). | Posted | Number | Percentage of participants | 2 ,4, 8, 12 and 16 Weeks |
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| Secondary | Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. | The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues). | Posted | Number | Percentage of participants | 16, 24 and 48 Weeks |
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| Secondary | Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. | The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues). | Posted | Number | Percentage of participants | 48 and 72 Weeks |
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| Secondary | Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively. | The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues). | Posted | Number | Percentage of participants | 2, 4, 8, 12, 16 Weeks |
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| Secondary | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively. | The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues). | Posted | Number | Percentage of participants | 16, 24 and 48 Weeks |
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| Secondary | Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively. | The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues). | Posted | Number | Percentage of participants | 48 and 72 Weeks |
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| Secondary | Percentage of Participants Who Have Failed on One Anti-TNFα Achieving PASI 75 (Subgroups 1 and 2 Combined) at 16 Weeks | PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. | The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues). | Posted | Number | Percentage of participants | 16 Weeks |
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| Secondary | Percentage of Participants Achieving NICE Continuation Criteria (PASI 75 or PASI 50 Plus a 5 Point Improvement in DLQI) at 16 Weeks | PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. | The full analysis set was analyzed. | Posted | Number | Percentage of participants | 16 Weeks |
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| Secondary | Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Scores - Initiation Period | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement. | The full analysis set was considered for the analysis. Only participants who had both baseline and post baseline measurements for a given time point were analyzed for that time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 12, and week 16 |
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| Secondary | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement. | The full analysis set was considered for the analysis. Only participants who had both baseline and post baseline measurements for a given time point were analyzed for that time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 16, 24 and 48 weeks |
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| Secondary | Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period | The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement. | The full analysis set was considered for the analysis. Only participants who had both baseline and post baseline measurements for a given time point were analyzed for that time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 48 and 72 weeks |
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| Secondary | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Initiation Period | The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. | The full analysis set was considered for the analysis. Only participants with measurements at each given time point were analyzed for that time point. | Posted | Mean | Standard Deviation | percent change | Baseline, 12 and 16 weeks |
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| Secondary | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period | The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. | The full analysis set was considered for the analysis. Only participants with measurements at each given time point were analyzed for that time point. | Posted | Mean | Standard Deviation | percent change | Baseline, 16, 24 and 48 weeks |
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| Secondary | Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period | The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. | The full analysis set was considered for the analysis. Only participants with measurements at each given time point were analyzed for that time point. | Posted | Mean | Standard Deviation | percent change | Baseline, 48 and 72 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Secukinumab (AIN457) 150mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. | 14 | 115 | 88 | 115 | ||
| EG001 | Secukinumab (AIN457) 300mg | Participants self-administered 300 mg secukinumab loading dose subcutaneously at Day 0 (initiation of study drug) and at weeks 1, 2, 3 & 4, and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the National Institute for Health and Care Excellence (NICE) criteria of adequate response were eligible to continue on study treatment for a further 32 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks. Participants not meeting this NICE criterion returned to routine treatment under the care of their usual Clinical Team. | 24 | 179 | 152 | 179 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Electrocution | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Vulval abscess | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Alcoholic seizure | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Drug withdrawal convulsions | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Glomerulonephritis proliferative | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pregnancy of partner | Social circumstances | MedDRA (18.0) | Systematic Assessment |
| |
| Diabetic macroangiopathy | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-1873 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C555450 | secukinumab |
Not provided
Not provided
Not provided
| Protocol deviation |
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| Withdrawal by Subject |
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| Lack of Efficacy |
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| Adverse Event |
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| Abnormal laboratory value |
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| Protocol deviation |
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| Lost to Follow-up |
|
| Withdrawal by Subject |
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| Lack of Efficacy |
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| Adverse Event |
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| Male |
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| OG002 | Secukinumab (AIN457) 300 mg Subgroup 3 | All participants who have tried and failed more than one anti-TNFalpha therapies |
| OG003 | Secukinumab (AIN457) 150 mg Subgroup 1 | Participants who had experienced an IR after trying the first anti-tumor necrosis factor-alpha (TNFalpha) therapy |
| OG004 | Secukinumab (AIN457) 150 mg Subgroup 2 | Participants who had initially experienced an adequate response after trying the first TNFalpha therapy, but then subsequently lost that response |
| OG005 | Secukinumab (AIN457) 150 mg Subgroup 3 | All participants who have tried and failed more than one anti-TNFalpha therapies |
|
|
| OG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
|
|
| OG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
| OG002 | Secukinumab (AIN457) 150 mg - 300 mg (Maintanence Period 1) | Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16. |
|
|
| OG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
| OG002 | Secukinumab (AIN457) 150 mg - 300 mg (Maintanence Period 1) | Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16. |
| OG003 | Secukinumab (AIN457) 150 mg - 300 mg (Maintenance Period 2) | Non-responders at secukinumab 150 mg from maintenance 1 period were uptitrated to secukinumab 300 mg at week 48. |
|
|
| OG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
|
|
| OG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
| OG002 | Secukinumab (AIN457) 150 mg - 300 mg (Maintanence Period 1) | Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16. |
|
|
| OG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
| OG002 | Secukinumab (AIN457) 150 mg - 300 mg (Maintanence Period 1) | Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16. |
| OG003 | Secukinumab (AIN457) 150 mg - 300 mg (Maintenance Period 2) | Non-responders at secukinumab 150 mg from maintenance 1 period were uptitrated to secukinumab 300 mg at week 48. |
|
|
Participants who experienced an IR after trying first anti-TNFalpha therapy and participants who had initially experienced an adequate response after trying the first anti-TNFalpha therapy but then had subsequently lost that response.
|
|
| Secukinumab (AIN457) 150 mg |
Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
|
|
| OG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
|
|
| OG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
| OG002 | Secukinumab (AIN457) 150 mg - 300 mg (Maintanence Period 1) | Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16. |
|
|
| OG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
| OG002 | Secukinumab (AIN457) 150 mg - 300 mg (Maintanence Period 1) | Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16. |
| OG003 | Secukinumab (AIN457) 150 mg - 300 mg (Maintenance Period 2) | Non-responders at secukinumab 150 mg from maintenance 1 period were uptitrated to secukinumab 300 mg at week 48. |
|
|
| OG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
|
|
| OG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
| OG002 | Secukinumab (AIN457) 150 mg - 300 mg (Maintanence Period 1) | Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16. |
|
|
| OG001 | Secukinumab (AIN457) 150 mg | Participants self-administered secukinumab 150 mg loading dose subcutaneously at Day 0 (initiation of study drug), weeks 1, 2, 3 & 4 and then every 4 weeks. Following the Primary Endpoint at 16 weeks, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 32 weeks at the 150mg dose. Participants not achieving the NICE criteria at the Primary Endpoint were up titrated to 300mg at the discretion of the treating physician. Following assessment at week 48, participants meeting the NICE criteria of adequate response were eligible to continue on study treatment for a further 24 weeks at the 150mg dose. Participants not achieving the NICE criteria at 48 weeks on the 150mg dose were up titrated to 300mg at the discretion of the treating physician. |
| OG002 | Secukinumab (AIN457) 150 mg - 300 mg (Maintanence Period 1) | Non-responders at secukinumab 150mg from the initiation period were uptitrated to secukinumab 300 mg at week 16. |
| OG003 | Secukinumab (AIN457) 150 mg - 300 mg (Maintenance Period 2) | Non-responders at secukinumab 150 mg from maintenance 1 period were uptitrated to secukinumab 300 mg at week 48. |
|
|
| Title | Measurements |
|---|---|
|
|