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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004439-22 | EudraCT Number |
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This study was to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self administration in subjects with active PsA despite current or previous NSAID, DMARD and/or anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data were collected during the post Week 52 period of the study.
At baseline (BSL), subjects whose eligibility was confirmed were randomized to one of the following four treatment groups.
Subjects who were randomized to a secukinumab treatment group at baseline were targeted to remain on the same dose for the entire trial.
Subjects who were randomized to placebo at baseline were re-randomized at Week 16 as follows:
Placebo non-responders received secukinumab 150 mg s.c. or 300 mg s.c. (1:1) every 4 weeks, starting after the efficacy assessments at Week 16.
Placebo responders continued to receive placebo at Week 16 and Week 20 and received secukinumab 150 mg s.c. or 300 mg s.c. (1:1) every 4 weeks, starting after the efficacy assessments at Week 24.
This was a double-blind, double-dummy, randomized treatment trial until week 52 analysis was completed and open label afterwards.
An amendment to the study protocol (after all patients were in the trial for 2-3 years) introduced changes whereby patients previously treated with secukinumab 75 mg s.c. could change to receive 150 mg s.c. or 300 mg s.c., and patients previously treated with secukinumab 150 mg s.c. could change to receive 300 mg s.c., as deemed appropriate by the investigators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab (AIN457) 75 mg s.c. | Experimental | Secukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4. |
|
| Secukinumab (AIN457) 150 mg s.c. | Experimental | Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4. |
|
| Secukinumab (AIN457) 300 mg s.c. | Experimental | Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 |
|
| Placebo s.c. | Placebo Comparator | Placebo at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4. Non-responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 16. Responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab (AIN457) | Drug | Secukinumab (AIN457) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria | ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their ACR20 was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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 response was defined as participants achieving >= 75% improvement from baseline. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their value was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. |
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Inclusion Criteria:Patients eligible for inclusion in this study have to fulfill all of the following criteria:
Exclusion Criteria:Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Peoria | Arizona | 85381 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38446397 | Derived | Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6. | |
| 38268157 |
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At baseline, all eligible subjects were randomized via Interactive Response Technology (IRT) to one of the 4 treatment arms.
At Week 16, Subjects on Placebo were rerandomized to receive secukinumab 150 mg s.c. or 300 mg s.c. from Week 16 (non-responder) or Week 24 (responder).
The study population was comprised of subjects who had passed screening assessments, complied with eligibility criteria and had provided written consent
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab (AIN457) 75 mg s.c. | Secukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 150 mg s.c. or 300 mg s.c |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Up to Week 24 (Primary Analysis) |
|
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| Placebo | Drug | Placebo PFS for s.c. administration. |
|
| Week 24 |
| Number of Participants Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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 90 response was defined as participants achieving >= 90% improvement from baseline. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their value was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. | Week 24 |
| Change From Baseline in DAS28-CRP | The DAS28 is a measure of disease activity based on Swollen and Tender Joint Counts, ESR or CRP and the Patient Global Assessment. A DAS28 score > 5.1 implies active disease, ≤ 3.2 low disease activity, and < 2.6 remission. The score can range from 0 - 9.4. The data collected after the patient switched to secukinumab were treated as missing for placebo patients and were analyzed using a mixed-effects repeated measures model. For secukinumab patients, the actual values were used in the analysis. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Baseline, Week 24 |
| Change From Baseline in SF36-Physical Component Score | The SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. Score range is from 0 (no problems) to 100 (unable to perform the activity). SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS was used. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Baseline, Week 24 |
| Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) | The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Baseline, Week 24 |
| Number of Participants Achieving American College of Rheumatology 50 (ACR50) Response Criteria | ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their ACR20 was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Week 24 |
| Number of Participants With Dactylitis in the Subset of Subjects Who Had Dactylitis at Baseline | Resolution of dactylitis was evaluated in the subset of patients who had disease activity at baseline. In this analysis, a lower percentage is desirable and resolution is defined as complete absence of the symptom. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their assessment was set to nonresponse at Week 24 (presence of dactylitis). This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Week 24 |
| Number of Participants With Enthesitis in the Subset of Subjects Who Had Enthesitis at Baseline | Resolution of enthesitis was evaluated in the subset of patients who had disease activity at baseline. In this analysis, a lower percentage is desirable and resolution is defined as complete absence of the symptom. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their assessment was set to nonresponse at Week 24 (presence of enthesitis). This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Week 24 |
| Aventura |
| Florida |
| 33180 |
| United States |
| Novartis Investigative Site | Palm Harbor | Florida | 34684 | United States |
| Novartis Investigative Site | Sarasota | Florida | 34239 | United States |
| Novartis Investigative Site | Tamarac | Florida | 33321 | United States |
| Novartis Investigative Site | Tampa | Florida | 33624 | United States |
| Novartis Investigative Site | Zephyrhills | Florida | 33542 | United States |
| Novartis Investigative Site | Lincoln | Nebraska | 68516 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68114 | United States |
| Novartis Investigative Site | Freehold | New Jersey | 07728 | United States |
| Novartis Investigative Site | Syracuse | New York | 13210 | United States |
| Novartis Investigative Site | Asheville | North Carolina | 28801 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28210 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73102 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73103 | United States |
| Novartis Investigative Site | Duncansville | Pennsylvania | 16635 | United States |
| Novartis Investigative Site | Charleston | South Carolina | 29460 | United States |
| Novartis Investigative Site | Columbia | South Carolina | 29204 | United States |
| Novartis Investigative Site | Greenville | South Carolina | 29601 | United States |
| Novartis Investigative Site | League City | Texas | 77573 | United States |
| Novartis Investigative Site | Mesquite | Texas | 75150 | United States |
| Novartis Investigative Site | Kogarah | New South Wales | 2217 | Australia |
| Novartis Investigative Site | Maroochydore | Queensland | 4558 | Australia |
| Novartis Investigative Site | Hobart | Tasmania | 7000 | Australia |
| Novartis Investigative Site | Malvern East | Victoria | 3145 | Australia |
| Novartis Investigative Site | Genk | 3600 | Belgium |
| Novartis Investigative Site | Hasselt | 3500 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Winnipeg | Manitoba | R3A 1M3 | Canada |
| Novartis Investigative Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Novartis Investigative Site | Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Novartis Investigative Site | Québec | Quebec | G1W 4R4 | Canada |
| Novartis Investigative Site | Sainte-Foy | Quebec | G1W 4Y5 | Canada |
| Novartis Investigative Site | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Novartis Investigative Site | Bruntál | Czech Republic | 792 01 | Czechia |
| Novartis Investigative Site | Pardubice | Czech Republic | 53002 | Czechia |
| Novartis Investigative Site | Prague | 128 50 | Czechia |
| Novartis Investigative Site | Uherské Hradiště | 686 01 | Czechia |
| Novartis Investigative Site | Aachen | 52064 | Germany |
| Novartis Investigative Site | Berlin | 12203 | Germany |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Erlangen | 91056 | Germany |
| Novartis Investigative Site | Germering | 82110 | Germany |
| Novartis Investigative Site | Hamburg | 22081 | Germany |
| Novartis Investigative Site | Herne | 44649 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| Novartis Investigative Site | Zerbst | 39261 | Germany |
| Novartis Investigative Site | Lodz | 90-265 | Poland |
| Novartis Investigative Site | Poznan | 60 529 | Poland |
| Novartis Investigative Site | Poznan | 60-218 | Poland |
| Novartis Investigative Site | Warsaw | 02 691 | Poland |
| Novartis Investigative Site | Warsaw | 04141 | Poland |
| Novartis Investigative Site | Wroclaw | 50-368 | Poland |
| Novartis Investigative Site | Ponce | 00716 | Puerto Rico |
| Novartis Investigative Site | Chelyabinsk | 454076 | Russia |
| Novartis Investigative Site | Kazan' | 420097 | Russia |
| Novartis Investigative Site | Moscow | 115522 | Russia |
| Novartis Investigative Site | Petrozavodsk | 185019 | Russia |
| Novartis Investigative Site | Rostov-on-Don | 344022 | Russia |
| Novartis Investigative Site | Saint Petersburg | 190068 | Russia |
| Novartis Investigative Site | Sestroretsk | 197706 | Russia |
| Novartis Investigative Site | Yaroslavl | 150003 | Russia |
| Novartis Investigative Site | Yekaterinburg | 620028 | Russia |
| Novartis Investigative Site | Bangkok | 10400 | Thailand |
| Novartis Investigative Site | London | England | E11 1NR | United Kingdom |
| Novartis Investigative Site | Salford | Manchester | M6 8HD | United Kingdom |
| Novartis Investigative Site | Cannock | Staffordshire | WS11 2XY | United Kingdom |
| Novartis Investigative Site | Guildford | Surrey | GU2 7XX | United Kingdom |
| Novartis Investigative Site | Dudley | West Midlands | DY1 2HQ | United Kingdom |
| Novartis Investigative Site | Leeds | West Yorkshire | LS7 4SA | United Kingdom |
| Novartis Investigative Site | Blackpool | FY3 7EN | United Kingdom |
| Novartis Investigative Site | Cambridge | CB2 2QQ | United Kingdom |
| Novartis Investigative Site | Glasgow | G51 4TF | United Kingdom |
| Novartis Investigative Site | London | NW3 2QG | United Kingdom |
| Novartis Investigative Site | London | SE1 9RT | United Kingdom |
| Novartis Investigative Site | Southampton | SO16 6YD | United Kingdom |
| McInnes IB, Mease PJ, Kivitz AJ, Nash P, Rahman P, Rech J, Conaghan PG, Kirkham B, Navarra S, Belsare AD, Delicha EM, Pricop L. Long-term efficacy and safety of secukinumab in patients with psoriatic arthritis: 5-year (end-of-study) results from the phase 3 FUTURE 2 study. Lancet Rheumatol. 2020 Apr;2(4):e227-e235. doi: 10.1016/S2665-9913(20)30036-9. |
| 34795065 | Derived | Pournara E, Kormaksson M, Nash P, Ritchlin CT, Kirkham BW, Ligozio G, Pricop L, Ogdie A, Coates LC, Schett G, McInnes IB. Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis. RMD Open. 2021 Nov;7(3):e001845. doi: 10.1136/rmdopen-2021-001845. |
| 31801620 | Derived | Coates LC, Wallman JK, McGonagle D, Schett GA, McInnes IB, Mease PJ, Rasouliyan L, Quebe-Fehling E, Asquith DL, Fasth AER, Pricop L, Gaillez C. Secukinumab efficacy on resolution of enthesitis in psoriatic arthritis: pooled analysis of two phase 3 studies. Arthritis Res Ther. 2019 Dec 4;21(1):266. doi: 10.1186/s13075-019-2055-z. |
| 31203228 | Derived | Deodhar A, Gladman DD, McInnes IB, Spindeldreher S, Martin R, Pricop L, Porter B, Safi J Jr, Shete A, Bruin G. Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. J Rheumatol. 2020 Apr;47(4):539-547. doi: 10.3899/jrheum.190116. Epub 2019 Jun 15. |
| 30526678 | Derived | Coates LC, Gladman DD, Nash P, FitzGerald O, Kavanaugh A, Kvien TK, Gossec L, Strand V, Rasouliyan L, Pricop L, Ding K, Jugl SM, Gaillez C; FUTURE 2 study group. Secukinumab provides sustained PASDAS-defined remission in psoriatic arthritis and improves health-related quality of life in patients achieving remission: 2-year results from the phase III FUTURE 2 study. Arthritis Res Ther. 2018 Dec 7;20(1):272. doi: 10.1186/s13075-018-1773-y. |
| 29880010 | Derived | McInnes IB, Mease PJ, Schett G, Kirkham B, Strand V, Williams N, Fox T, Pricop L, Jugl SM, Gandhi KK; FUTURE 2 Study Group. Secukinumab provides rapid and sustained pain relief in psoriatic arthritis over 2 years: results from the FUTURE 2 study. Arthritis Res Ther. 2018 Jun 7;20(1):113. doi: 10.1186/s13075-018-1610-3. |
| 29409133 | Derived | Coates LC, Mease PJ, Gossec L, Kirkham B, Sherif B, Gaillez C, Mpofu S, Jugl SM, Karyekar C, Gandhi KK. Minimal Disease Activity Among Active Psoriatic Arthritis Patients Treated With Secukinumab: 2-Year Results From a Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Study. Arthritis Care Res (Hoboken). 2018 Oct;70(10):1529-1535. doi: 10.1002/acr.23537. Epub 2018 Sep 1. |
| 28968735 | Derived | McInnes IB, Mease PJ, Ritchlin CT, Rahman P, Gottlieb AB, Kirkham B, Kajekar R, Delicha EM, Pricop L, Mpofu S. Secukinumab sustains improvement in signs and symptoms of psoriatic arthritis: 2 year results from the phase 3 FUTURE 2 study. Rheumatology (Oxford). 2017 Nov 1;56(11):1993-2003. doi: 10.1093/rheumatology/kex301. |
| 26135703 | Derived | McInnes IB, Mease PJ, Kirkham B, Kavanaugh A, Ritchlin CT, Rahman P, van der Heijde D, Landewe R, Conaghan PG, Gottlieb AB, Richards H, Pricop L, Ligozio G, Patekar M, Mpofu S; FUTURE 2 Study Group. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015 Sep 19;386(9999):1137-46. doi: 10.1016/S0140-6736(15)61134-5. Epub 2015 Jun 28. |
| Secukinumab (AIN457) 150 mg s.c. |
Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 300 mg s.c |
| FG002 | Secukinumab (AIN457) 300 mg s.c. | Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. |
| FG003 | Placebo - AIN457 150 mg | Placebo - rerandomized to AIN457 150 mg starting at Week 16 (non-responder) or Week 24 (responder). After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 300 mg s.c |
| FG004 | Placebo - AIN457 300 mg | Placebo - rerandomized to AIN457 300 mg starting at Week 16 (non-responder) or Week 24 (responder). |
| FG005 | Placebo - Not Rerandomized | Placebo - not rerandomized (subjects discontinued prior to rerandomization scheduled for week 16) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Week 24 to Week 260 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab (AIN457) 75 mg s.c. | Secukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 150 mg s.c. or 300 mg s.c |
| BG001 | Secukinumab (AIN457) 150 mg s.c. | Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 300 mg s.c |
| BG002 | Secukinumab (AIN457) 300 mg s.c. | Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. |
| BG003 | Placebo - AIN457 150 mg | Placebo - rerandomized to AIN457 150 mg starting at Week 16 (non-responder) or Week 24 (responder). After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 300 mg s.c |
| BG004 | Placebo - AIN457 300 mg | Placebo - rerandomized to AIN457 300 mg starting at Week 16 (non-responder) or Week 24 (responder). |
| BG005 | Placebo - Not Rerandomized | Placebo - not rerandomized (subjects discontinued prior to rerandomization scheduled for week 16) |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria | ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their ACR20 was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Full Analysis Set. | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | Number of Participants Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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 response was defined as participants achieving >= 75% improvement from baseline. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their value was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. | Psoriasis Subset (≥3% skin involvement with psoriasis at baseline) | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a 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 90 response was defined as participants achieving >= 90% improvement from baseline. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their value was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. | Psoriasis Subset (≥3% skin involvement with psoriasis at baseline) | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in DAS28-CRP | The DAS28 is a measure of disease activity based on Swollen and Tender Joint Counts, ESR or CRP and the Patient Global Assessment. A DAS28 score > 5.1 implies active disease, ≤ 3.2 low disease activity, and < 2.6 remission. The score can range from 0 - 9.4. The data collected after the patient switched to secukinumab were treated as missing for placebo patients and were analyzed using a mixed-effects repeated measures model. For secukinumab patients, the actual values were used in the analysis. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Full Analysis Set, including only participants with measurements at baseline and Week 24. Participants in the Placebo arm who switched to Secukinumab prior to Week 24 were treated as missing. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in SF36-Physical Component Score | The SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. Score range is from 0 (no problems) to 100 (unable to perform the activity). SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS was used. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Full Analysis Set, including only participants with measurements at baseline and Week 24. Participants in the Placebo arm who switched to Secukinumab prior to Week 24 were treated as missing. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) | The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Full Analysis Set, including only participants with measurements at baseline and Week 24. Participants in the Placebo arm who switched to Secukinumab prior to Week 24 were treated as missing. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving American College of Rheumatology 50 (ACR50) Response Criteria | ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their ACR20 was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Full Analysis Set | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Dactylitis in the Subset of Subjects Who Had Dactylitis at Baseline | Resolution of dactylitis was evaluated in the subset of patients who had disease activity at baseline. In this analysis, a lower percentage is desirable and resolution is defined as complete absence of the symptom. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their assessment was set to nonresponse at Week 24 (presence of dactylitis). This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Dactylitis Subset (participants with dactylitis at baseline) | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Enthesitis in the Subset of Subjects Who Had Enthesitis at Baseline | Resolution of enthesitis was evaluated in the subset of patients who had disease activity at baseline. In this analysis, a lower percentage is desirable and resolution is defined as complete absence of the symptom. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their assessment was set to nonresponse at Week 24 (presence of enthesitis). This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. | Enthesitis Subset (participants with enthesitis at baseline) | Posted | Count of Participants | Participants | Week 24 |
|
Adverse events were reported from first dose of study treatment until Last Patient Last Visit (LPLV), up to a maximum of 5 years.
Patients randomized to Placebo at Baseline are reported under Placebo for AEs starting before switching to Secukinumab (non-responder Week 16 / responder Week 24) and under the respective Secukinumab arm for AEs starting after switching to Secukinumab. Patients who, following the protocol amendment, switched to a higher dose are reporteed under the arm (dose) where the AE occurred.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Any AIN457 75 mg | Any AIN457 75 mg | 0 | 99 | 17 | 99 | 63 | 99 |
| EG001 | Any AIN457 150 mg | Any AIN457 150 mg | 1 | 193 | 28 | 193 | 132 | 193 |
| EG002 | Any AIN457 300 mg | Any AIN457 300 mg | 0 | 251 | 42 | 251 | 171 | 251 |
| EG003 | Placebo | Placebo | 0 | 98 | 3 | 98 | 39 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Visual acuity reduced transiently | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Lumbar hernia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hepatic lesion | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Periorbital abscess | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pharyngeal abscess | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Fractured ischium | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Intervertebral disc injury | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Scar | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Arthrofibrosis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Patellofemoral pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Penile squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Throat cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.1) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA (21.1) | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dependence | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pregnancy of partner | Social circumstances | MedDRA (21.1) | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Vasculitis necrotising | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| C563250 | Salivary Gland Adenoma, Pleomorphic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| 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
| Subject/guardian decision |
|
| Physician Decision |
|
| Death |
|
| Pregnancy |
|
| Noncompliance with study treatment |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Odds Ratio (OR) |
| 6.52 |
| 2-Sided |
| 95 |
| 3.25 |
| 13.08 |
| Superiority |
| Regression, Logistic | <.0001 | Odds Ratio (OR) | 6.81 | 2-Sided | 95 | 3.42 | 13.56 | Superiority |
Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 300 mg s.c |
| OG002 | Secukinumab (AIN457) 300 mg s.c. | Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. |
| OG003 | Placebo s.c. | Placebo at BSL, Weeks 1, 2, 3 and 4, followed by placebo dosing every four weeks starting at Week 4 until up to Week 12 (non-responder) or Week 20 (responder) followed by re-randomization to AIN 150 mg s.c. or AIN 300 mg s.c. (starting from Week 16 or 24). After a protocol amendment (introduced in open label phase > 2 years post randomization) patients re-randomized to 150 mg s.c. could be changed to 300 mg s.c. Treatment could continue up to Week 260. |
|
|
|
Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 300 mg s.c |
| OG002 | Secukinumab (AIN457) 300 mg s.c. | Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. |
| OG003 | Placebo s.c. | Placebo at BSL, Weeks 1, 2, 3 and 4, followed by placebo dosing every four weeks starting at Week 4 until up to Week 12 (non-responder) or Week 20 (responder) followed by re-randomization to AIN 150 mg s.c. or AIN 300 mg s.c. (starting from Week 16 or 24). After a protocol amendment (introduced in open label phase > 2 years post randomization) patients re-randomized to 150 mg s.c. could be changed to 300 mg s.c. Treatment could continue up to Week 260. |
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| OG002 | Secukinumab (AIN457) 300 mg s.c. | Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. |
| OG003 | Placebo s.c. | Placebo at BSL, Weeks 1, 2, 3 and 4, followed by placebo dosing every four weeks starting at Week 4 until up to Week 12 (non-responder) or Week 20 (responder) followed by re-randomization to AIN 150 mg s.c. or AIN 300 mg s.c. (starting from Week 16 or 24). After a protocol amendment (introduced in open label phase > 2 years post randomization) patients re-randomized to 150 mg s.c. could be changed to 300 mg s.c. Treatment could continue up to Week 260. |
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| OG002 | Secukinumab (AIN457) 300 mg s.c. | Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. |
| OG003 | Placebo s.c. | Placebo at BSL, Weeks 1, 2, 3 and 4, followed by placebo dosing every four weeks starting at Week 4 until up to Week 12 (non-responder) or Week 20 (responder) followed by re-randomization to AIN 150 mg s.c. or AIN 300 mg s.c. (starting from Week 16 or 24). After a protocol amendment (introduced in open label phase > 2 years post randomization) patients re-randomized to 150 mg s.c. could be changed to 300 mg s.c. Treatment could continue up to Week 260. |
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| OG001 | Secukinumab (AIN457) 150 mg s.c. | Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 300 mg s.c |
| OG002 | Secukinumab (AIN457) 300 mg s.c. | Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. |
| OG003 | Placebo s.c. | Placebo at BSL, Weeks 1, 2, 3 and 4, followed by placebo dosing every four weeks starting at Week 4 until up to Week 12 (non-responder) or Week 20 (responder) followed by re-randomization to AIN 150 mg s.c. or AIN 300 mg s.c. (starting from Week 16 or 24). After a protocol amendment (introduced in open label phase > 2 years post randomization) patients re-randomized to 150 mg s.c. could be changed to 300 mg s.c. Treatment could continue up to Week 260. |
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Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. After a protocol amendment (introduced in open label phase > 2 years post randomization) patients could be changed to 300 mg s.c |
| OG002 | Secukinumab (AIN457) 300 mg s.c. | Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. |
| OG003 | Placebo s.c. | Placebo at BSL, Weeks 1, 2, 3 and 4, followed by placebo dosing every four weeks starting at Week 4 until up to Week 12 (non-responder) or Week 20 (responder) followed by re-randomization to AIN 150 mg s.c. or AIN 300 mg s.c. (starting from Week 16 or 24). After a protocol amendment (introduced in open label phase > 2 years post randomization) patients re-randomized to 150 mg s.c. could be changed to 300 mg s.c. Treatment could continue up to Week 260. |
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| OG002 | Secukinumab (AIN457) 300 mg s.c. | Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. |
| OG003 | Placebo s.c. | Placebo at BSL, Weeks 1, 2, 3 and 4, followed by placebo dosing every four weeks starting at Week 4 until up to Week 12 (non-responder) or Week 20 (responder) followed by re-randomization to AIN 150 mg s.c. or AIN 300 mg s.c. (starting from Week 16 or 24). After a protocol amendment (introduced in open label phase > 2 years post randomization) patients re-randomized to 150 mg s.c. could be changed to 300 mg s.c. Treatment could continue up to Week 260. |
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| OG002 | Secukinumab (AIN457) 300 mg s.c. | Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until up to Week 260. |
| OG003 | Placebo s.c. | Placebo at BSL, Weeks 1, 2, 3 and 4, followed by placebo dosing every four weeks starting at Week 4 until up to Week 12 (non-responder) or Week 20 (responder) followed by re-randomization to AIN 150 mg s.c. or AIN 300 mg s.c. (starting from Week 16 or 24). After a protocol amendment (introduced in open label phase > 2 years post randomization) patients re-randomized to 150 mg s.c. could be changed to 300 mg s.c. Treatment could continue up to Week 260. |
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