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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004477-32 | EudraCT Number |
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This was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).
The total maximum study duration, including the screening period was up to 76 weeks.
At Baseline, patients whose eligibility was confirmed were randomized to 1 of 2 groups (1:1): Group 1 (secukinumab 300 mg) or Group 2 (adalimumab 40 mg).
In order to maintain the blind, both groups received 1 or 2 placebo s.c. injections to keep consistency in the number of injections at each dosing visit. Secukinumab (300 mg) was available in 2 x 1.0 mL pre-filled syringes (PFS) and adalimumab was available in 1 x 0.4 mL PFS. Placebo (1.0 and 0.5 mL PFS) was also available.
Secukinumab 300 mg s.c injection (2 x 1 mL PFS) was administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks to Week 48.
Adalimumab 40 mg (1 x 0.4 mL PFS) was administered at Baseline followed by dosing every 2 weeks until Week 50.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab 300 mg s.c. | Experimental | Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48. |
|
| Adalimumab 40 mg s.c. | Active Comparator | Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Biological | Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52 | Clinical response, failure to permanently discontinue study medication prematurely, and lack of need for rescue medication was required for a patient to achieve treatment success. The primary endpoint is the proportion of patients with monotherapy ACR20 response at Week 52 where monotherapy ACR20 response is defined as meeting the following 3 conditions:
| Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52 | The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. |
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Key Inclusion Criteria:
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 | Fountain Valley | California | 92708 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37097894 | Derived | Kaeley GS, Schett G, Conaghan PG, McGonagle D, Behrens F, Goupille P, Gaillez C, Parikh B, Bakewell C. Enthesitis in patients with psoriatic arthritis treated with secukinumab or adalimumab: a post hoc analysis of the EXCEED study. Rheumatology (Oxford). 2024 Jan 4;63(1):41-49. doi: 10.1093/rheumatology/kead181. | |
| 32386593 | Derived |
| Label | URL |
|---|---|
| Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial | View source |
Not provided
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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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853 patients were randomized in a 1:1 ratio to receive secukinumab 300 mg (N=426) or adalimumab 40 mg (N=427); All randomized patients were analyzed for efficacy and safety.
This study was conducted at 161 centers in 26 countries worldwide: Australia, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Israel, Italy, South Korea, Latvia, Lithuania, The Netherlands, Poland, Portugal, Russia, Slovakia, Spain, UK and USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Secukinumab 300 mg s.c. | Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48. |
| FG001 | Adalimumab 40 mg s.c. | Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 24, 2019 | Dec 8, 2020 |
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| Adalimumab | Biological | Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio |
|
| Week 52 |
| Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52 | Clinical response, failure to permanently discontinue study medication prematurely, and lack of need for rescue medication was required for a patient to achieve treatment success. The secondary endpoint is the proportion of patients with monotherapy ACR50 response at Week 52 where monotherapy ACR50 response is defined as meeting the following 3 conditions:
| Week 52 |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52 | 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. | Baseline, Week 52 |
| Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52 | Enthesitis refers to inflammation of entheses, the site where ligaments or tendons insert into the bones. Resolution was defined as the absence of recorded enthesitis; conducted by the study assessor. | Week 52 |
| Fullerton |
| California |
| 92835 |
| United States |
| Novartis Investigative Site | La Mesa | California | 91942 | United States |
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| Novartis Investigative Site | Hobart | Tasmania | 7000 | Australia |
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| Novartis Investigative Site | Pleven | 5800 | Bulgaria |
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| Novartis Investigative Site | Plovdiv | 4002 | Bulgaria |
| Novartis Investigative Site | Sofia | 1413 | Bulgaria |
| Novartis Investigative Site | Sofia | 1606 | Bulgaria |
| Novartis Investigative Site | Victoria | British Columbia | V8V 3M9 | Canada |
| Novartis Investigative Site | Winnipeg | Manitoba | R3A 1M1 | Canada |
| Novartis Investigative Site | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Novartis Investigative Site | Bruntál | 792 01 | Czechia |
| Novartis Investigative Site | Prague | 128 50 | Czechia |
| Novartis Investigative Site | Prague | 150 06 | Czechia |
| Novartis Investigative Site | Uherské Hradiště | 686 01 | Czechia |
| Novartis Investigative Site | Zlín | 760 01 | Czechia |
| Novartis Investigative Site | Frederiksberg | DK-2000 | Denmark |
| Novartis Investigative Site | Tallinn | 10138 | Estonia |
| Novartis Investigative Site | Tallinn | 13419 | Estonia |
| Novartis Investigative Site | Tartu | 50406 | Estonia |
| Novartis Investigative Site | Hyvinkää | 05800 | Finland |
| Novartis Investigative Site | Kuopio | 70100 | Finland |
| Novartis Investigative Site | Brive-la-Gaillarde | 19100 | France |
| Novartis Investigative Site | Cahors | 46000 | France |
| Novartis Investigative Site | Chambray-lès-Tours | 37170 | France |
| Novartis Investigative Site | Le Mans | 72037 | France |
| Novartis Investigative Site | Orléans | 45100 | France |
| Novartis Investigative Site | Paris | 75010 | France |
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| Novartis Investigative Site | Bad Doberan | 18209 | Germany |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Berlin | 12161 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Berlin | 14059 | Germany |
| Novartis Investigative Site | Bochum | 44791 | Germany |
| Novartis Investigative Site | Erlangen | 91056 | Germany |
| Novartis Investigative Site | Hamburg | 22415 | Germany |
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| Novartis Investigative Site | Leipzig | 04103 | Germany |
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| Novartis Investigative Site | Athens | 115 27 | Greece |
| Novartis Investigative Site | Athens | 12462 | Greece |
| Novartis Investigative Site | Thessaloniki | 54642 | Greece |
| Novartis Investigative Site | Budapest | 1023 | Hungary |
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| Novartis Investigative Site | Debrecen | 4032 | Hungary |
| Novartis Investigative Site | Győr | 9023 | Hungary |
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| Novartis Investigative Site | Veszprém | 8200 | Hungary |
| Novartis Investigative Site | Reykjavik | 108 | Iceland |
| Novartis Investigative Site | Mumbai | Maharashtra | 400 053 | India |
| Novartis Investigative Site | Nashik | Maharashtra | 422 101 | India |
| Novartis Investigative Site | Secunderabad | Telangana | 500003 | India |
| Novartis Investigative Site | New Delhi | 110029 | India |
| Novartis Investigative Site | Haifa | 3339419 | Israel |
| Novartis Investigative Site | Haifa | 343621 | Israel |
| Novartis Investigative Site | Haifa | 3525408 | Israel |
| Novartis Investigative Site | Kfar Saba | 4428164 | Israel |
| Novartis Investigative Site | Petah Tikva | 49100 | Israel |
| Novartis Investigative Site | Ramat Gan | 52621 | Israel |
| Novartis Investigative Site | Tel Aviv | 6423906 | Israel |
| Novartis Investigative Site | Arenzano | GE | 16011 | Italy |
| Novartis Investigative Site | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Verona | VR | 37126 | Italy |
| Novartis Investigative Site | Bologna | 40138 | Italy |
| Novartis Investigative Site | Pisa | 56126 | Italy |
| Novartis Investigative Site | Torino | 10126 | Italy |
| Novartis Investigative Site | Riga | LV-1005 | Latvia |
| Novartis Investigative Site | Valmiera | LV-4201 | Latvia |
| Novartis Investigative Site | Kaunas | LTU | LT 50161 | Lithuania |
| Novartis Investigative Site | Klaipėda | LT-92288 | Lithuania |
| Novartis Investigative Site | Šiauliai | LT-76231 | Lithuania |
| Novartis Investigative Site | Enschede | 7513 ER | Netherlands |
| Novartis Investigative Site | Sneek | 8601 ZK | Netherlands |
| Novartis Investigative Site | Dopiewo | 62 069 | Poland |
| Novartis Investigative Site | Szczecin | 71-252 | Poland |
| Novartis Investigative Site | Warsaw | 02 637 | Poland |
| Novartis Investigative Site | Warsaw | 04141 | Poland |
| Novartis Investigative Site | Lisbon | 1050-034 | Portugal |
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| Novartis Investigative Site | Ponte de Lima | 4990 041 | Portugal |
| Novartis Investigative Site | Porto | 4099 001 | Portugal |
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| Novartis Investigative Site | Kemerovo | 650029 | Russia |
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| Novartis Investigative Site | Moscow | 115522 | Russia |
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| Novartis Investigative Site | Nizhny Novgorod | 603018 | Russia |
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| Novartis Investigative Site | Rostov-on-Don | 344022 | Russia |
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| Novartis Investigative Site | Bratislava | 81369 | Slovakia |
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| Novartis Investigative Site | Seoul | Seocho Gu | 06591 | South Korea |
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| Novartis Investigative Site | Torquay | Devon | TQ2 7AA | United Kingdom |
| Novartis Investigative Site | Leytonstone | London | E11 1NR | United Kingdom |
| Novartis Investigative Site | Salford | Manchester | M6 8HD | United Kingdom |
| Novartis Investigative Site | Cannock | Staffordshire | WS11 5XY | United Kingdom |
| Novartis Investigative Site | Stoke-on-Trent | Staffordshire | ST6 7AG | United Kingdom |
| Novartis Investigative Site | Edinburgh | EH4 2XU | United Kingdom |
| Novartis Investigative Site | Glasgow | G31 2ER | United Kingdom |
| Novartis Investigative Site | Hull | HU3 2JZ | United Kingdom |
| Novartis Investigative Site | London | NW3 2QG | United Kingdom |
| Novartis Investigative Site | London | SE1 9RT | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Novartis Investigative Site | Plymouth | PL6 8DH | United Kingdom |
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| McInnes IB, Behrens F, Mease PJ, Kavanaugh A, Ritchlin C, Nash P, Masmitja JG, Goupille P, Korotaeva T, Gottlieb AB, Martin R, Ding K, Pellet P, Mpofu S, Pricop L; EXCEED Study Group. Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial. Lancet. 2020 May 9;395(10235):1496-1505. doi: 10.1016/S0140-6736(20)30564-X. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Secukinumab 300 mg s.c. | Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48. |
| BG001 | Adalimumab 40 mg s.c. | Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52 | Clinical response, failure to permanently discontinue study medication prematurely, and lack of need for rescue medication was required for a patient to achieve treatment success. The primary endpoint is the proportion of patients with monotherapy ACR20 response at Week 52 where monotherapy ACR20 response is defined as meeting the following 3 conditions:
| Full Analysis Set (FAS) | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 52 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52 | The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. | Psoriasis Subset of the Full Analysis Set (FAS) | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 52 |
|
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| Secondary | Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52 | Clinical response, failure to permanently discontinue study medication prematurely, and lack of need for rescue medication was required for a patient to achieve treatment success. The secondary endpoint is the proportion of patients with monotherapy ACR50 response at Week 52 where monotherapy ACR50 response is defined as meeting the following 3 conditions:
| Full Analysis Set (FAS) | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52 | 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. | Full Analysis Set (FAS) | Posted | Least Squares Mean | Standard Error | Unit on a scale | Baseline, Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52 | Enthesitis refers to inflammation of entheses, the site where ligaments or tendons insert into the bones. Resolution was defined as the absence of recorded enthesitis; conducted by the study assessor. | Enthesitis Subset (LEI) of the Full Analysis Set (FAS) | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 52 |
|
|
Treatment emergent adverse events were collected from first dose of study treatment until 12 Weeks (84 days) following the last administration of study treatment, an average of 68 weeks.
Any sign or symptom that occurs during the study treatment plus the 30 days post-treatment.
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 | AIN457 300 mg | Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48. | 1 | 426 | 37 | 426 | 226 | 426 |
| EG001 | Adalimumab 40 mg | Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50. | 0 | 427 | 36 | 427 | 236 | 427 |
| EG002 | Total | Total | 1 | 853 | 73 | 853 | 462 | 853 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Splenic artery aneurysm | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Lower respiratory tract infection fungal | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Measles | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Mycobacterial infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Puncture site abscess | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| VIIIth nerve injury | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Synovial sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Horner's syndrome | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Endometrial hypertrophy | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Perioral dermatitis | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.1) | 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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2019 | Dec 8, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| 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 |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| American Indian or Alaska Native |
|
| Black or African American |
|
| White |
|
| Unknown |
|
| Other |
|
| Counts |
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| Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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