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Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement (MAXIMISE)

Primary Purpose

Axial Psoratic Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Secukinumab

Secukinumab and Placebo

About this trial

This is an interventional treatment trial for Axial Psoratic Arthritis focused on measuring Assessment of spondyloarthritis international society, ASAS, axial, Psoriatic Arthritis, PsA, Magnetic resonance imaging, MRI

Eligibility Criteria

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

Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed
Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic arthritis (CASPAR) criteria
Active spinal disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4
Spinal Pain visual analog scale (VAS) ≥ 40 (on a VAS 100 scale)
Inadequate Response to at least 2 non-steroidal anti-inflammatory drugs over a 4 weeks period

Exclusion Criteria:

History of exposure to other IL-17 or IL-23 inhibitor biologic drug
History of exposure to previous biologic disease modifying anti-rheumatic drugs (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab)
Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than Methotrexate
Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician

Other protocol-defined inclusion and exclusion criteria may have applied.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

AIN457 150mg

AIN457 300mg

AIN457 Placebo

Arm Description

Secukinumab dose amount 1 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 1 sc injection every 4 weeks for remaining 44 weeks

Secukinumab dose amount 2 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 2 sc injection every 4 weeks for remaining 44 weeks

Placebo sc injection weekly for 4 weeks and at week 8, followed by Secukinumab 150 mg or 300 mg sc injection every 4 week for remaining 40 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Response to Treatment (300 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12

Purpose of this measure: was to demonstrate that secukinumab 150 mg s.c. is superior to placebo in the achievement of ASAS 20 response at Week 12 after superiority of 300 mg was established ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥10 unit (0-100 mm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (total pain score), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)

Secondary Outcome Measures

Percentage of Participants With Response to Treatment (150 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12

Purpose of this key secondary measure: was to demonstrate that secukinumab 150 mg s.c. is superior to placebo in the achievement of ASAS 20 response at Week 12 after superiority of 300 mg was established. 300mg and 150mg are presented side by side for clarity; and to align with protocol. 300mg data is for Primary outcome; and 150mg data is for key secondary outcome ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥10 unit (0-100 mm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (total pain score), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)

Percentage of Participants With Response to Treatment (150 mg/300 mg AIN457) as Assessed by the ASAS40 Criteria at Week 12

Proportion of patients with response to treatment as assessed by the Assessment of spondyloarthritis international society (ASAS) 40 criteria at week 12. ASAS40 was defined as an improvement of ≥40% and absolute improvement of ≥20 unit (0-100 mm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (total pain score), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)

Percentage of Participants With Response to Treatment as Assessed by BASDAI50 at Week 12

Bath ankylosing spondylitis disease activity index (BASDAI) 50 response BASDAI 50 response is defined as at least 50% improvement (decrease) in total BASDAI score.

Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Any Time

Change from baseline in Spinal pain visual analog scale (VAS) at week 12 VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best). VAS measures pain and stress for on a horizontal line of 100 mm, ranging from very low (0) to very high (100).

Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Night

Change From Baseline Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index Score at Week 12

The Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index score range is 0-16, where 0 is the best outcome, and 16 the worst. The assessor determines whether the site shows tenderness and therefore would count as site with enthesitis. This is done by applying pressure to the site and getting feedback from patient about whether the site is tender.

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12

The health assessment questionnaire disability index (HAQ-DI) assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability.

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) at Week 12

The FACIT-fatigue scale is a 13-item patient-reported measure of fatigue with a 7-day recall period. Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so". To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52.

Change From Baseline in Spondyloarthritis International Society (ASAS) Health Index at Week 12

Statistical analysis (using ANCOVA) of change from baseline in spondyloarthritis international society (ASAS) Health Index score by visit - treatment period 1 ASAS HI is a disease-specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17-item instrument has scores ranging from 0 (good health) to 17 (poor health). Each item consists of one question that the participant needs to respond to with either "I agree" (score of 1) or "I do not agree" (score of 0). A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors

Percentage of Participants With Response to Treatment as Assessed by the ACR20 Criteria at Week 12

American College of Rheumatology 20% (ACR20) Response at Week 12 is the % of responders with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)

Full Information

NCT ID

NCT02721966

First Posted

March 23, 2016

Last Updated

September 9, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02721966

Brief Title

Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement

Acronym

MAXIMISE

Official Title

MAXIMISE (Managing AXIal Manifestations in PsorIatic Arthritis With SEcukinumab), a Randomized, Double-blind, Placebo-controlled, Multicenter, 52-week Study to Assess the Efficacy and Safety of Secukinumab 150 mg or 300 mg s.c. in Participants With Active Psoriatic Arthritis and Axial Skeleton Involvement Who Have Inadequate Response to Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

October 3, 2016 (Actual)

Primary Completion Date

June 26, 2019 (Actual)

Study Completion Date

June 26, 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).

Detailed Description

In the anlalysis (CSR), there are 498 patients, as 5 patients were mis-randomized, i.e. had randomization number but did never take study medication. So there were 498 participants, and not 503

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Axial Psoratic Arthritis

Keywords

Assessment of spondyloarthritis international society, ASAS, axial, Psoriatic Arthritis, PsA, Magnetic resonance imaging, MRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

498 patients were randomized in this Phase 3b trial. 5 (of 503) were mis-randomized, i.e. received randomization number but never received study medication. This was a 52-week, randomized, double-blind, double-dummy, placebo-controlled, multicenter study to assess the efficacy of secukinumab 150 mg or 300 mg in patients with AxPsA who had an inadequate response to NSAIDs. The study had 2 treatment periods; a placebo-controlled period from Baseline to Week 12 followed by an active treatment period from Week 12 to Week 52. At Week 12, patients randomized to placebo at Baseline were re-randomized (1:1) to active treatment with secukinumab 150 mg or secukinumab 300 mg.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

503 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AIN457 150mg

Arm Type

Experimental

Arm Description

Secukinumab dose amount 1 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 1 sc injection every 4 weeks for remaining 44 weeks

Arm Title

AIN457 300mg

Arm Type

Experimental

Arm Description

Secukinumab dose amount 2 sc injection weekly for 4 weeks followed by Secukinumab dosage amount 2 sc injection every 4 weeks for remaining 44 weeks

Arm Title

AIN457 Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo sc injection weekly for 4 weeks and at week 8, followed by Secukinumab 150 mg or 300 mg sc injection every 4 week for remaining 40 weeks.

Intervention Type

Biological

Intervention Name(s)

Secukinumab

Other Intervention Name(s)

AIN457

Intervention Description

Anti IL-17a monoclonal antibody

Intervention Type

Drug

Intervention Name(s)

Secukinumab and Placebo

Intervention Description

Placebo matching AIN457

Primary Outcome Measure Information:

Title

Percentage of Participants With Response to Treatment (300 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12

Description

Time Frame

at week 12

Secondary Outcome Measure Information:

Title

Percentage of Participants With Response to Treatment (150 mg AIN457) as Assessed by the ASAS20 Criteria at Week 12

Description

Time Frame

at week 12

Title

Percentage of Participants With Response to Treatment (150 mg/300 mg AIN457) as Assessed by the ASAS40 Criteria at Week 12

Description

Time Frame

at week 12

Title

Percentage of Participants With Response to Treatment as Assessed by BASDAI50 at Week 12

Description

Bath ankylosing spondylitis disease activity index (BASDAI) 50 response BASDAI 50 response is defined as at least 50% improvement (decrease) in total BASDAI score.

Time Frame

at week 12

Title

Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Any Time

Description

Time Frame

at baseline, at week 12

Title

Change From Baseline in Spinal Pain Visual Analog Scale (VAS) - Pain at Night

Description

Time Frame

at baseline, at week 12

Title

Change From Baseline Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index Score at Week 12

Description

Time Frame

baseline and week 12

Title

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12

Description

Time Frame

baseline and week 12

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) at Week 12

Description

Time Frame

baseline and week 12

Title

Change From Baseline in Spondyloarthritis International Society (ASAS) Health Index at Week 12

Description

Time Frame

baseline and week 12

Title

Percentage of Participants With Response to Treatment as Assessed by the ACR20 Criteria at Week 12

Description

Time Frame

at week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent must be obtained before any assessment is performed Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic arthritis (CASPAR) criteria Active spinal disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4 Spinal Pain visual analog scale (VAS) ≥ 40 (on a VAS 100 scale) Inadequate Response to at least 2 non-steroidal anti-inflammatory drugs over a 4 weeks period Exclusion Criteria: History of exposure to other IL-17 or IL-23 inhibitor biologic drug History of exposure to previous biologic disease modifying anti-rheumatic drugs (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab) Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than Methotrexate Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine) Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician Other protocol-defined inclusion and exclusion criteria may have applied.

Facility Information:

Facility Name

Novartis Investigative Site

City

Brussels

ZIP/Postal Code

BE-B-1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Ruse

ZIP/Postal Code

7002

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

1505

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Brno

ZIP/Postal Code

63800

Country

Czechia

Facility Name

Novartis Investigative Site

City

Bruntal

ZIP/Postal Code

792 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen-Bory

ZIP/Postal Code

30599

Country

Czechia

Facility Name

Novartis Investigative Site

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

50406

Country

Estonia

Facility Name

Novartis Investigative Site

City

Kuopio

ZIP/Postal Code

70100

Country

Finland

Facility Name

Novartis Investigative Site

City

Kuovola

ZIP/Postal Code

45100

Country

Finland

Facility Name

Novartis Investigative Site

City

Strasbourg

State/Province

Cedex

ZIP/Postal Code

67098

Country

France

Facility Name

Novartis Investigative Site

City

Lyon

ZIP/Postal Code

69003

Country

France

Facility Name

Novartis Investigative Site

City

Nantes

ZIP/Postal Code

44000

Country

France

Facility Name

Novartis Investigative Site

City

PARIS Cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse Cedex

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10789

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Novartis Investigative Site

City

Cottbus

ZIP/Postal Code

03042

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22391

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39110

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

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Novartis Investigative Site

City

Eger

ZIP/Postal Code

3300

Country

Hungary

Facility Name

Novartis Investigative Site

City

Heviz

ZIP/Postal Code

8380

Country

Hungary

Facility Name

Novartis Investigative Site

City

Miskolc

ZIP/Postal Code

H-3529

Country

Hungary

Facility Name

Novartis Investigative Site

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Dublin 8

Country

Ireland

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

343621

Country

Israel

Facility Name

Novartis Investigative Site

City

Kfar Saba

ZIP/Postal Code

44281

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

Bergamo

State/Province

ZIP/Postal Code

24128

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10126

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10128

Country

Italy

Facility Name

Novartis Investigative Site

City

Verona

State/Province

ZIP/Postal Code

37134

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15 351

Country

Poland

Facility Name

Novartis Investigative Site

City

Bydgoszcz

ZIP/Postal Code

85 168

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-121

Country

Poland

Facility Name

Novartis Investigative Site

City

Piotrkow Trybunalski

ZIP/Postal Code

97-300

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60 529

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-773

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02637

Country

Poland

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

030167

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

ZIP/Postal Code

011172

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

Novartis Investigative Site

City

Izhevsk

ZIP/Postal Code

426009

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420064

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Khanty-Mansiysk

ZIP/Postal Code

628012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kursk

ZIP/Postal Code

305007

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115093

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

123182

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Orenburg

ZIP/Postal Code

460000

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Elche

State/Province

Alicante

ZIP/Postal Code

03203

Country

Spain

Facility Name

Novartis Investigative Site

City

Cordoba

State/Province

Andalucia

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novartis Investigative Site

City

Terrassa

State/Province

Barcelona

ZIP/Postal Code

08221

Country

Spain

Facility Name

Novartis Investigative Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Novartis Investigative Site

City

Salamanca

State/Province

Castilla Y Leon

ZIP/Postal Code

37007

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Lugo

State/Province

Galicia

ZIP/Postal Code

27003

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

Las Palmas de Gran Canaria

State/Province

Las Palmas De G.C

ZIP/Postal Code

35020

Country

Spain

Facility Name

Novartis Investigative Site

City

El Palmar

State/Province

Murcia

ZIP/Postal Code

30120

Country

Spain

Facility Name

Novartis Investigative Site

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Pontevedra

ZIP/Postal Code

36001

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

Novartis Investigative Site

City

Vitoria Gasteiz

ZIP/Postal Code

01009

Country

Spain

Facility Name

Novartis Investigative Site

City

Fribourg

State/Province

ZIP/Postal Code

1708

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

St Gallen

ZIP/Postal Code

CH 9007

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zuerich

ZIP/Postal Code

CH 8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Devon

State/Province

Barnstaple

ZIP/Postal Code

EX31 4JB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Basingstoke

State/Province

Hampshire

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Maidstone

State/Province

Kent

ZIP/Postal Code

ME16 9QQ

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

Bradford

State/Province

West Yorkshire

ZIP/Postal Code

BD5 0NA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS7 4SA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Hull

ZIP/Postal Code

HU3 2JZ

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

Undecided

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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

33334727

Citation

Baraliakos X, Gossec L, Pournara E, Jeka S, Mera-Varela A, D'Angelo S, Schulz B, Rissler M, Nagar K, Perella C, Coates LC. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021 May;80(5):582-590. doi: 10.1136/annrheumdis-2020-218808. Epub 2020 Dec 17.

Results Reference

derived

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Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement

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Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement (MAXIMISE)

Axial Psoratic Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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