Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745080
• Other study ID #: CAIN457F2366
• Secondary ID: 2015-004477-32
• Status: Completed
• Phase: Phase 3
• Start date: April 3, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 853
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Biological:
• Secukinumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
• Adalimumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Hobart	Tasmania
Australia	Novartis Investigative Site	Kogarah	New South Wales
Australia	Novartis Investigative Site	Malvern East	Victoria
Australia	Novartis Investigative Site	Maroochydore	Queensland
Bulgaria	Novartis Investigative Site	Pleven
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Sofia
Bulgaria	Novartis Investigative Site	Sofia
Canada	Novartis Investigative Site	Trois-Rivieres	Quebec
Canada	Novartis Investigative Site	Victoria	British Columbia
Canada	Novartis Investigative Site	Winnipeg	Manitoba
Czechia	Novartis Investigative Site	Bruntal
Czechia	Novartis Investigative Site	Praha 2
Czechia	Novartis Investigative Site	Praha 5
Czechia	Novartis Investigative Site	Uherske Hradiste
Czechia	Novartis Investigative Site	Zlin
Denmark	Novartis Investigative Site	Frederiksberg
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tallinn
Estonia	Novartis Investigative Site	Tartu
Finland	Novartis Investigative Site	Hyvinkaa
Finland	Novartis Investigative Site	Kuopio
France	Novartis Investigative Site	Brive-la-Gaillarde
France	Novartis Investigative Site	Cahors
France	Novartis Investigative Site	Chambray les Tours
France	Novartis Investigative Site	Le Mans
France	Novartis Investigative Site	Orleans
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Poitiers
Germany	Novartis Investigative Site	Bad Doberan
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Herne
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Osnabruck
Germany	Novartis Investigative Site	Schwerin
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Thessaloniki
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Gyor
Hungary	Novartis Investigative Site	Kistarcsa
Hungary	Novartis Investigative Site	Veszprem
Iceland	Novartis Investigative Site	Reykjavik
India	Novartis Investigative Site	Mumbai	Maharashtra
India	Novartis Investigative Site	Nashik	Maharashtra
India	Novartis Investigative Site	New Delhi
India	Novartis Investigative Site	Secunderabad	Telangana
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Kfar Saba
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Ramat Gan
Israel	Novartis Investigative Site	Tel Aviv
Italy	Novartis Investigative Site	Arenzano	GE
Italy	Novartis Investigative Site	Bologna
Italy	Novartis Investigative Site	Pisa
Italy	Novartis Investigative Site	Rozzano	MI
Italy	Novartis Investigative Site	Torino
Italy	Novartis Investigative Site	Verona	VR
Korea, Republic of	Novartis Investigative Site	Seoul	Seocho Gu
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Valmiera
Lithuania	Novartis Investigative Site	Kaunas	LTU
Lithuania	Novartis Investigative Site	Klaipeda
Lithuania	Novartis Investigative Site	Siauliai
Netherlands	Novartis Investigative Site	Enschede
Netherlands	Novartis Investigative Site	Sneek
Poland	Novartis Investigative Site	Dopiewo
Poland	Novartis Investigative Site	Szczecin
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Ponte de Lima
Portugal	Novartis Investigative Site	Porto
Portugal	Novartis Investigative Site	Porto
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Kemerovo
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Nizhny Novgorod
Russian Federation	Novartis Investigative Site	Petrozavodsk
Russian Federation	Novartis Investigative Site	Rostov on Don
Russian Federation	Novartis Investigative Site	Smolensk
Russian Federation	Novartis Investigative Site	Yaroslavl
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Partizanske
Slovakia	Novartis Investigative Site	Topolcany
Spain	Novartis Investigative Site	Badalona	Barcelona
Spain	Novartis Investigative Site	Baracaldo	Vizcaya
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Bilbao	Pais Vasco
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	L Hospitalet De Llobregat	Barcelona
Spain	Novartis Investigative Site	La Coruna	Galicia
Spain	Novartis Investigative Site	La Laguna	Santa Cruz De Tenerife
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Merida	Extremadura
Spain	Novartis Investigative Site	Sabadell	Barcelona
Spain	Novartis Investigative Site	Santander	Cantabria
Spain	Novartis Investigative Site	Santiago de Compostela	Galicia
Spain	Novartis Investigative Site	Sevilla
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
United Kingdom	Novartis Investigative Site	Cannock	Staffordshire
United Kingdom	Novartis Investigative Site	Edinburgh
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Hull
United Kingdom	Novartis Investigative Site	Leytonstone	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Newcastle Upon Tyne
United Kingdom	Novartis Investigative Site	Plymouth
United Kingdom	Novartis Investigative Site	Salford	Manchester
United Kingdom	Novartis Investigative Site	Solihull
United Kingdom	Novartis Investigative Site	Stoke on Trent	Staffordshire
United Kingdom	Novartis Investigative Site	Torquay	Devon
United Kingdom	Novartis Investigative Site	Wigan
United Kingdom	Novartis Investigative Site	Wolverhampton
United States	Novartis Investigative Site	Arlington	Texas
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Bethlehem	Pennsylvania
United States	Novartis Investigative Site	Bowling Green	Kentucky
United States	Novartis Investigative Site	Burlington	Vermont
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Duncansville	Pennsylvania
United States	Novartis Investigative Site	Fountain Valley	California
United States	Novartis Investigative Site	Fullerton	California
United States	Novartis Investigative Site	Glendale	Wisconsin
United States	Novartis Investigative Site	La Mesa	California
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Mesquite	Texas
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative Site	Saint Louis	Missouri
United States	Novartis Investigative Site	Seattle	Washington
United States	Novartis Investigative Site	Spokane	Washington
United States	Novartis Investigative Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Iceland,  India,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Netherlands,  Poland,  Portugal,  Russian Federation,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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: 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)	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.	Week 52
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: 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)	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.	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.	Week 52

External Links

•   Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial