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Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis (EXCEED 1)

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Secukinumab
Adalimumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, secukinumab, adalimumab, monoclonal antibody, CASPAR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Diagnosis of PsA classified by CASPAR
  • Rheumatoid factor and anti-CCP antibodies negative
  • Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of >= 2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis
  • Inadequate control of symptoms with NSAIDs
  • Inadequate control of symptoms with a conventional DMARD.

Key Exclusion Criteria:

  • Pregnant or nursing women
  • Evidence of ongoing infectious or malignant process
  • Previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis
  • Subjects taking high potency opioid analgesics
  • Ongoing use of prohibited psoriasis treatments/medications
  • Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 investigational agents.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Secukinumab 300 mg s.c.

Adalimumab 40 mg s.c.

Arm Description

Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.

Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.

Outcomes

Primary Outcome Measures

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: achieving American College of Rheumatology 20 (ACR20) response no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 50 (the last dosing visit) no use of conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs) cDMARDs (including Methotrexate (MTX)) after Week 36 (regardless of the starting time of taking cDMARDs)

Secondary Outcome Measures

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.
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: achieving American College of Rheumatology 50 (ACR50) response no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 52 no use of conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs) cDMARDs (including Methotrexate (MTX)) after Week 36 (regardless of the starting time of taking cDMARDs)
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.
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.

Full Information

First Posted
April 1, 2016
Last Updated
January 26, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02745080
Brief Title
Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
Acronym
EXCEED 1
Official Title
A Randomized, Double-blind, Active Control, Multicenter Study to Evaluate the Efficacy at Week 52 of Secukinumab Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Psoriatic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Psoriatic Arthritis, secukinumab, adalimumab, monoclonal antibody, CASPAR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
853 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Secukinumab 300 mg s.c.
Arm Type
Experimental
Arm Description
Secukinumab 300 mg administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.
Arm Title
Adalimumab 40 mg s.c.
Arm Type
Active Comparator
Arm Description
Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.
Intervention Type
Biological
Intervention Name(s)
Secukinumab
Other Intervention Name(s)
AIN457
Intervention Description
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Intervention Description
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52
Description
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: achieving American College of Rheumatology 20 (ACR20) response no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 50 (the last dosing visit) no use of conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs) cDMARDs (including Methotrexate (MTX)) after Week 36 (regardless of the starting time of taking cDMARDs)
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52
Description
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.
Time Frame
Week 52
Title
Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52
Description
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: achieving American College of Rheumatology 50 (ACR50) response no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 52 no use of conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs) cDMARDs (including Methotrexate (MTX)) after Week 36 (regardless of the starting time of taking cDMARDs)
Time Frame
Week 52
Title
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52
Description
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.
Time Frame
Baseline, Week 52
Title
Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52
Description
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.
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diagnosis of PsA classified by CASPAR Rheumatoid factor and anti-CCP antibodies negative Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of >= 2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis Inadequate control of symptoms with NSAIDs Inadequate control of symptoms with a conventional DMARD. Key Exclusion Criteria: Pregnant or nursing women Evidence of ongoing infectious or malignant process Previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis Subjects taking high potency opioid analgesics Ongoing use of prohibited psoriasis treatments/medications Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 investigational agents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Novartis Investigative Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Novartis Investigative Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Novartis Investigative Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Novartis Investigative Site
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Novartis Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Novartis Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Novartis Investigative Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Novartis Investigative Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Novartis Investigative Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Novartis Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Novartis Investigative Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Novartis Investigative Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Novartis Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Novartis Investigative Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Novartis Investigative Site
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Novartis Investigative Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Novartis Investigative Site
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Novartis Investigative Site
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Novartis Investigative Site
City
Malvern East
State/Province
Victoria
ZIP/Postal Code
3145
Country
Australia
Facility Name
Novartis Investigative Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1413
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M1
Country
Canada
Facility Name
Novartis Investigative Site
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Novartis Investigative Site
City
Bruntal
ZIP/Postal Code
792 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Novartis Investigative Site
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Frederiksberg
ZIP/Postal Code
DK-2000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Novartis Investigative Site
City
Hyvinkaa
ZIP/Postal Code
05800
Country
Finland
Facility Name
Novartis Investigative Site
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Novartis Investigative Site
City
Brive-la-Gaillarde
ZIP/Postal Code
19100
Country
France
Facility Name
Novartis Investigative Site
City
Cahors
ZIP/Postal Code
46000
Country
France
Facility Name
Novartis Investigative Site
City
Chambray les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Novartis Investigative Site
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Novartis Investigative Site
City
Orleans
ZIP/Postal Code
45100
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Novartis Investigative Site
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Novartis Investigative Site
City
Bad Doberan
ZIP/Postal Code
18209
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91056
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
Novartis Investigative Site
City
Herne
ZIP/Postal Code
44649
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39110
Country
Germany
Facility Name
Novartis Investigative Site
City
Osnabruck
ZIP/Postal Code
49074
Country
Germany
Facility Name
Novartis Investigative Site
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Novartis Investigative Site
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Novartis Investigative Site
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Novartis Investigative Site
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Novartis Investigative Site
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Novartis Investigative Site
City
Reykjavik
ZIP/Postal Code
108
Country
Iceland
Facility Name
Novartis Investigative Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 053
Country
India
Facility Name
Novartis Investigative Site
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422 101
Country
India
Facility Name
Novartis Investigative Site
City
Secunderabad
State/Province
Telangana
ZIP/Postal Code
500003
Country
India
Facility Name
Novartis Investigative Site
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
343621
Country
Israel
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
3525408
Country
Israel
Facility Name
Novartis Investigative Site
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Novartis Investigative Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novartis Investigative Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Novartis Investigative Site
City
Arenzano
State/Province
GE
ZIP/Postal Code
16011
Country
Italy
Facility Name
Novartis Investigative Site
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Novartis Investigative Site
City
Verona
State/Province
VR
ZIP/Postal Code
37126
Country
Italy
Facility Name
Novartis Investigative Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Novartis Investigative Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Seocho Gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Riga
ZIP/Postal Code
LV-1005
Country
Latvia
Facility Name
Novartis Investigative Site
City
Valmiera
ZIP/Postal Code
LV-4201
Country
Latvia
Facility Name
Novartis Investigative Site
City
Kaunas
State/Province
LTU
ZIP/Postal Code
LT 50161
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Siauliai
ZIP/Postal Code
LT-76231
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Sneek
ZIP/Postal Code
8601 ZK
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Dopiewo
ZIP/Postal Code
62 069
Country
Poland
Facility Name
Novartis Investigative Site
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02 637
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
04141
Country
Poland
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1050-034
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Novartis Investigative Site
City
Ponte de Lima
ZIP/Postal Code
4990 041
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4099 001
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4200 319
Country
Portugal
Facility Name
Novartis Investigative Site
City
Ekaterinburg
ZIP/Postal Code
620028
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kemerovo
ZIP/Postal Code
650029
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kemerovo
ZIP/Postal Code
650056
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Nizhny Novgorod
ZIP/Postal Code
603018
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Rostov on Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
81369
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Partizanske
ZIP/Postal Code
95801
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Topolcany
ZIP/Postal Code
95501
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Cordoba
State/Province
Andalucia
ZIP/Postal Code
14004
Country
Spain
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29009
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Facility Name
Novartis Investigative Site
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Novartis Investigative Site
City
L Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Novartis Investigative Site
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Novartis Investigative Site
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46017
Country
Spain
Facility Name
Novartis Investigative Site
City
Merida
State/Province
Extremadura
ZIP/Postal Code
06800
Country
Spain
Facility Name
Novartis Investigative Site
City
La Coruna
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Facility Name
Novartis Investigative Site
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Facility Name
Novartis Investigative Site
City
Bilbao
State/Province
Pais Vasco
ZIP/Postal Code
48013
Country
Spain
Facility Name
Novartis Investigative Site
City
La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Novartis Investigative Site
City
Baracaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novartis Investigative Site
City
Torquay
State/Province
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Leytonstone
State/Province
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Salford
State/Province
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Cannock
State/Province
Staffordshire
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Stoke on Trent
State/Province
Staffordshire
ZIP/Postal Code
ST6 7AG
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Glasgow
ZIP/Postal Code
G31 2ER
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Solihull
ZIP/Postal Code
B91 2JL
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Wigan
ZIP/Postal Code
WN6 9EP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Citations:
PubMed Identifier
32386593
Citation
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. Erratum In: Lancet. 2020 May 30;395(10238):1694.
Results Reference
derived
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/32386593/
Description
Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial

Learn more about this trial

Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis

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