Psoriatic ArthritisPhase 3EXCEED 1NCT02745080
Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
A Phase 3 study testing Secukinumab and Adalimumab in people with Psoriatic Arthritis, run by Novartis Pharmaceuticals at 156 sites in 26 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Secukinumab and Adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 853 participants
- Where
- 156 sitesin 26 countries
- Study dates
- 3 Apr 2017to 30 Dec 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
156 sites in 26 countries.
156 sites in 26 countries
Spain20 sites
Novartis Investigative Site
A Coruña, Galicia, 15006
Novartis Investigative Site
Badalona, Barcelona, 08916
Novartis Investigative Site
Barakaldo, Vizcaya, 48903
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Barcelona, 08025
Novartis Investigative Site
Bilbao, Basque Country, 48013
Novartis Investigative Site
Córdoba, Andalusia, 14004
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Madrid, 28942
Novartis Investigative Site
Málaga, Andalusia, 29009
Novartis Investigative Site
Mérida, Extremadura, 06800
Novartis Investigative Site
Sabadell, Barcelona, 08208
Novartis Investigative Site
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Novartis Investigative Site
Santander, Cantabria, 39008
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Seville, Andalusia, 41013
Novartis Investigative Site
Seville, 41014
Novartis Investigative Site
Valencia, Valencia, 46017
Novartis Investigative Site
Valencia, 46026
United States19 sites
Novartis Investigative Site
Arlington, Texas, 76011
Novartis Investigative Site
Austin, Texas, 78731
Novartis Investigative Site
Bethlehem, Pennsylvania, 18015
Novartis Investigative Site
Bowling Green, Kentucky, 42101
Novartis Investigative Site
Burlington, Vermont, 05401
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Duncansville, Pennsylvania, 16635
Novartis Investigative Site
Fountain Valley, California, 92708
Novartis Investigative Site
Fullerton, California, 92835
Novartis Investigative Site
Glendale, Wisconsin, 53217
Novartis Investigative Site
La Mesa, California, 91942
Novartis Investigative Site
Lincoln, Nebraska, 68516
Novartis Investigative Site
Mesquite, Texas, 75150
Novartis Investigative Site
Omaha, Nebraska, 68114
Novartis Investigative Site
Rochester, New York, 14623
Novartis Investigative Site
Seattle, Washington, 98122
Novartis Investigative Site
Spokane, Washington, 99204
Novartis Investigative Site
St Louis, Missouri, 63117
Novartis Investigative Site
Upland, California, 91786
United Kingdom15 sites
Novartis Investigative Site
Cannock, Staffordshire, WS11 5XY
Novartis Investigative Site
Edinburgh, EH4 2XU
Novartis Investigative Site
Glasgow, G31 2ER
Novartis Investigative Site
Hull, HU3 2JZ
Novartis Investigative Site
Leytonstone, London, E11 1NR
Novartis Investigative Site
London, NW3 2QG
Novartis Investigative Site
London, SE1 9RT
Novartis Investigative Site
Newcastle upon Tyne, NE7 7DN
Novartis Investigative Site
Plymouth, PL6 8DH
Novartis Investigative Site
Salford, Manchester, M6 8HD
Novartis Investigative Site
Solihull, B91 2JL
Novartis Investigative Site
Stoke-on-Trent, Staffordshire, ST6 7AG
Novartis Investigative Site
Torquay, Devon, TQ2 7AA
Novartis Investigative Site
Wigan, WN6 9EP
Novartis Investigative Site
Wolverhampton, WV10 0QP
Germany13 sites
Novartis Investigative Site
Bad Doberan, 18209
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Berlin, 12161
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Berlin, 14059
Novartis Investigative Site
Bochum, 44791
Novartis Investigative Site
Erlangen, 91056
Novartis Investigative Site
Hamburg, 22415
Novartis Investigative Site
Herne, 44649
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Magdeburg, 39110
Novartis Investigative Site
Osnabrück, 49074
Novartis Investigative Site
Schwerin, 19055
Russia10 sites
Novartis Investigative Site
Kemerovo, 650029
Novartis Investigative Site
Kemerovo, 650056
Novartis Investigative Site
Moscow, 115522
Novartis Investigative Site
Moscow, 119049
Novartis Investigative Site
Nizhny Novgorod, 603018
Novartis Investigative Site
Petrozavodsk, 185019
Novartis Investigative Site
Rostov-on-Don, 344022
Novartis Investigative Site
Smolensk, 214019
Novartis Investigative Site
Yaroslavl, 150003
Novartis Investigative Site
Yekaterinburg, 620028
France7 sites
Novartis Investigative Site
Brive-la-Gaillarde, 19100
Novartis Investigative Site
Cahors, 46000
Novartis Investigative Site
Chambray-lès-Tours, 37170
Novartis Investigative Site
Le Mans, 72037
Novartis Investigative Site
Orléans, 45100
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Poitiers, 86021
Hungary7 sites
Novartis Investigative Site
Budapest, 1023
Novartis Investigative Site
Budapest, 1027
Novartis Investigative Site
Budapest, 1062
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Győr, 9023
Novartis Investigative Site
Kistarcsa, 2143
Novartis Investigative Site
Veszprém, 8200
Israel7 sites
Novartis Investigative Site
Haifa, 3339419
Novartis Investigative Site
Haifa, 343621
Novartis Investigative Site
Haifa, 3525408
Novartis Investigative Site
Kfar Saba, 4428164
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Ramat Gan, 52621
Novartis Investigative Site
Tel Aviv, 6423906
Italy6 sites
Novartis Investigative Site
Arenzano, GE, 16011
Novartis Investigative Site
Bologna, 40138
Novartis Investigative Site
Pisa, 56126
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
Torino, 10126
Novartis Investigative Site
Verona, VR, 37126
Bulgaria5 sites
Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Plovdiv, 4000
Novartis Investigative Site
Plovdiv, 4002
Novartis Investigative Site
Sofia, 1413
Novartis Investigative Site
Sofia, 1606
Czechia5 sites
Novartis Investigative Site
Bruntál, 792 01
Novartis Investigative Site
Prague, 128 50
Novartis Investigative Site
Prague, 150 06
Novartis Investigative Site
Uherské Hradiště, 686 01
Novartis Investigative Site
Zlín, 760 01
Portugal5 sites
Novartis Investigative Site
Lisbon, 1050-034
Novartis Investigative Site
Lisbon, 1649-035
Novartis Investigative Site
Ponte de Lima, 4990 041
Novartis Investigative Site
Porto, 4099 001
Novartis Investigative Site
Porto, 4200 319
Australia4 sites
Novartis Investigative Site
Hobart, Tasmania, 7000
Novartis Investigative Site
Kogarah, New South Wales, 2217
Novartis Investigative Site
Malvern East, Victoria, 3145
Novartis Investigative Site
Maroochydore, Queensland, 4558
India4 sites
Novartis Investigative Site
Mumbai, Maharashtra, 400 053
Novartis Investigative Site
Nashik, Maharashtra, 422 101
Novartis Investigative Site
New Delhi, 110029
Novartis Investigative Site
Secunderabad, Telangana, 500003
Poland4 sites
Novartis Investigative Site
Dopiewo, 62 069
Novartis Investigative Site
Szczecin, 71-252
Novartis Investigative Site
Warsaw, 02 637
Novartis Investigative Site
Warsaw, 04141
Slovakia4 sites
Novartis Investigative Site
Bratislava, 81369
Novartis Investigative Site
Košice, 04011
Novartis Investigative Site
Partizánske, 95801
Novartis Investigative Site
Topoľčany, 95501
Canada3 sites
Novartis Investigative Site
Trois-Rivières, Quebec, G8Z 1Y2
Novartis Investigative Site
Victoria, British Columbia, V8V 3M9
Novartis Investigative Site
Winnipeg, Manitoba, R3A 1M1
Estonia3 sites
Novartis Investigative Site
Tallinn, 10138
Novartis Investigative Site
Tallinn, 13419
Novartis Investigative Site
Tartu, 50406
Greece3 sites
Novartis Investigative Site
Athens, 115 27
Novartis Investigative Site
Athens, 12462
Novartis Investigative Site
Thessaloniki, 54642
Lithuania3 sites
Novartis Investigative Site
Kaunas, LTU, LT 50161
Novartis Investigative Site
Klaipėda, LT-92288
Novartis Investigative Site
Šiauliai, LT-76231
Finland2 sites
Novartis Investigative Site
Hyvinkää, 05800
Novartis Investigative Site
Kuopio, 70100
Latvia2 sites
Novartis Investigative Site
Riga, LV-1005
Novartis Investigative Site
Valmiera, LV-4201
Netherlands2 sites
Novartis Investigative Site
Enschede, 7513 ER
Novartis Investigative Site
Sneek, 8601 ZK
About this study
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
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).
Read the 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.
- Conditions
- Psoriatic Arthritis
- Being tested
- Secukinumab, Adalimumab
- Keywords
- Psoriatic Arthritis, secukinumab, adalimumab, monoclonal antibody, CASPAR
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabBiological
Also called AIN457
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
AdalimumabBiological
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Secukinumab |
| Adalimumab 40 mg s.c. | Active comparator | Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50. Receives: Biological: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 52
Secondary outcomes (4)
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.
Measured: 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:
- 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)
Measured: 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.
Measured: 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.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start3 Apr 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 853 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745080
- Sponsor's protocol ID
- CAIN457F2366
- Other IDs
- 2015-004477-32, 2015
- Acronym
- EXCEED 1
- Status last verified
- Jan 2021
- First submitted
- 1 Apr 2016
- Last updated
- 27 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 37097894McInnes 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.
PubMed 32386593
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02745080
- Acronym / sponsor ID
- EXCEED 1 / CAIN457F2366
- Conditions
- Psoriatic Arthritis
- Keywords
- Psoriatic Arthritis, secukinumab, adalimumab, monoclonal antibody, CASPAR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 853 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Posted 27 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secukinumab 300 mg s.c. | Experimental | Biological: SecukinumabSecukinumab 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 | Biological: AdalimumabAdalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SecukinumabAlso: AIN457Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio | Biological | Secukinumab 300 mg s.c. |
| AdalimumabEligible subjects are randomized to one of two treatment arms in a 1:1 ratio | Biological | Adalimumab 40 mg s.c. |
Primary outcome
Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52
Time frame: 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: 1. achieving American College of Rheumatology 20 (ACR20) response 2. no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 50 (the last dosing visit) 3. 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)
4 secondary outcomes
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52
Time frame: Week 52
Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52
Time frame: Week 52
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52
Time frame: Baseline, Week 52
Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37097894Kaeley 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.
- Derived from this study: PubMed 32386593McInnes 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.
- Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
156 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Secukinumab and Adalimumab in people with Psoriatic Arthritis, run by Novartis Pharmaceuticals at 156 sites in 26 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 156 sites in Spain, United States, United Kingdom, Germany, Russia and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02745080, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.