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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02745080
Other study ID # CAIN457F2366
Secondary ID 2015-004477-32
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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