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An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis

Primary Purpose

Nonradiographic Axial Spondylitis, Ankylosing

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Group 1: Placebo

Group 2: Ustekinumab 45 mg

Group 3: Ustekinumab 90 mg

About this trial

This is an interventional treatment trial for Nonradiographic Axial Spondylitis, Ankylosing focused on measuring Nonradiographic Axial Spondylitis, Ankylosing, Ustekinumab

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants must be classified as having nonradiographic axial spondyloarthritis (nr-AxSpA) based on 2009 Assessment of SpondyloArthritis International Society (ASAS) criteria
Must have an age at nr-AxSpA onset of <= 45 years
Must have at screening or active inflammation on magnetic resonance imaging (MRI) as evidenced by the central readers and no radiographic sacroiliitis that fulfills the 1984 modified New York Criteria
Must have symptoms of active disease at screening and at baseline, as evidenced by both a BASDAI score of >= 4 and a visual analogue scale (VAS) score for total back pain of more than or equal to (>=) 4, each on a scale of 0 to 10

Exclusion Criteria:

Have radiographic sacroiliitis fulfilling the 1984 modified New York Criteria
Have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy
Have received any systemic immunosuppressives or disease-modifying anti-rheumatic drug (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent
Have received epidural, intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids, including adrenocorticotropic hormone during the 4 weeks prior to first administration of study agent
Have received prior biologic therapy other than anti-TNFα
Have received more than 1 prior anti-TNFα agent

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Group 1: Placebo

Group 2: Ustekinumab 45 milligram (mg)

Group 3: Ustekinumab 90 mg

Arm Description

Participants will receive placebo subcutaneously (SC) at Weeks 0, 4, 16, and 20. At Week 24, all participants (except those who early escaped) will crossover to receive ustekinumab 45 or 90 milligram (mg) SC at Weeks 24 and 28 followed by every 12 weeks up to Week 52. At Week 16, participants in placebo group with < 10% improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16 will enter early escape to receive ustekinumab 45 mg or 90 mg at Weeks 16, 20, and 28 followed by every 12 weeks up to Week 52. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and 52 will be re-randomized to receive placebo or ustekinumab every 12 weeks up to Week 88. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or 52 will continue with ustekinumab every 12 weeks up to Week 88. NOTE: Intervention Description should have no more than 800 characters.

Participants will receive ustekinumab 45 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will be re-randomized to receive either placebo or ustekinumab 45 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 45 mg every 12 weeks through Week 88.

Participants will receive ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will receive either placebo or ustekinumab 90 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 90 mg every 12 weeks through Week 88.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24

ASAS 20 defined as improvement of greater than or equal to (>=) 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 centimeter(cm) scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in remaining domain. ASAS20 response based on imputed data using treatment failure (consider non-responders at and after treatment failure),early escape rules (consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).

Secondary Outcome Measures

Percentage of Participants Who Achieved an ASAS 40 Response at Week 24

ASAS 40 defined as improvement of >= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor),total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10 cm; 0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).

Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24

The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness were added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24

The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of ankylosing spondylitis participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP) Inactive Disease (<1.3) at Week 24

ASDAS includes CRP milligram per liter (mg/L); four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included total back pain(TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain)+ (0.110*PGA)+ (0.073*peripheral pain/swelling)+ (0.058* DMS)+ (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI (missing responses at post baseline visit imputed as non-responder).

Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24

Change from baseline in hsCRP levels was reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing). Here 'n' signifies the number of participants who were analyzed at each specified timepoints, for each arm, respectively.

Percentage of Participants With ASAS 20 Components at Week 24

ASAS 20 defined as >= 20% improvement from baseline in 4 individual components of ASAS20: Patient's global assessment (PGA) of disease activity (0 to 10cm; 0=very well,10=very poor), total back pain(0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean(0 to10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to functional anatomy and 2 relate to participant's ability to cope with life) and Inflammation (0 to 10cm;0=none,10=very severe).

Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20

ASAS 40 defined as improvement of >= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure (consider non-responders at and after treatment failure), early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).

Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20

ASAS 20 defined as improvement of >= 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in remaining domain. ASAS20 response based on imputed data using treatment failure (consider non-responders at and after treatment failure),early escape rules (consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).

Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20

The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in BASDAI based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responders).

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20

The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Missing data were imputed using early escape rule (measurement value at Week 20 and 24 was set as missing). Here 'n' defined as number of participants who were analyzed at each specified timepoint, for each arm, respectively.

Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20

ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included total back pain(TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain)+ (0.110*PGA)+ (0.073*peripheral pain/swelling)+ (0.058* DMS)+ (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI (missing responses at post baseline visit imputed as non-responder).

Full Information

NCT ID

NCT02407223

First Posted

March 30, 2015

Last Updated

March 11, 2019

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT02407223

Brief Title

An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis

Official Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Terminated

Why Stopped

This study was stopped because ustekinumab did not achieve key endpoints in a related study. The safety profile was consistent with past ustekinumab studies.

Study Start Date

July 13, 2015 (Actual)

Primary Completion Date

September 26, 2017 (Actual)

Study Completion Date

September 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).

Detailed Description

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ustekinumab in the treatment of participants with active non-radiographic axial spondylo arthritis. Participants will receive either placebo or ustekinumab 45 or 90 milligram (mg). Participants will primarily be assessed for Assessment of Spondylo Arthritis (ASAS) International Society criteria 20 at Week 24. Safety will be monitored throughout the study.

6. Conditions and Keywords

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

Nonradiographic Axial Spondylitis, Ankylosing

Keywords

Nonradiographic Axial Spondylitis, Ankylosing, Ustekinumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

356 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Group 2: Ustekinumab 45 milligram (mg)

Arm Type

Experimental

Arm Description

Arm Title

Group 3: Ustekinumab 90 mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Group 1: Placebo

Intervention Description

Participants will receive placebo SC at Weeks 0, 4, 16, and 20. At Week 24, all participants (except those who early escaped) will crossover to receive ustekinumab 45 or 90 mg SC at Weeks 24 and 28 followed by every 12 weeks up to Week 52. At Week 16, participants in placebo group with < 10% improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16 will enter early escape to receive ustekinumab 45 mg or 90 mg at Weeks 16, 20, and 28 followed by every 12 weeks up to Week 52. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and 52 will be re-randomized to receive placebo or ustekinumab every 12 weeks up to Week 88. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or 52 will continue with ustekinumab every 12 weeks up to Week 88.

Intervention Type

Drug

Intervention Name(s)

Group 2: Ustekinumab 45 mg

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Group 3: Ustekinumab 90 mg

Intervention Description

Primary Outcome Measure Information:

Title

Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24

Description

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Percentage of Participants Who Achieved an ASAS 40 Response at Week 24

Description

Time Frame

Week 24

Title

Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24

Description

Time Frame

Week 24

Title

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24

Description

Time Frame

Baseline, Week 24

Title

Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP) Inactive Disease (<1.3) at Week 24

Description

Time Frame

Week 24

Title

Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24

Description

Time Frame

Baseline, Week 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants With ASAS 20 Components at Week 24

Description

Time Frame

Week 24

Title

Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20

Description

ASAS 40 defined as improvement of >= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure (consider non-responders at and after treatment failure), early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).

Time Frame

Week 4, 8, 12, 16 and 20

Title

Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20

Description

Time Frame

Week 4, 8, 12, 16 and 20

Title

Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20

Description

The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in BASDAI based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responders).

Time Frame

Week 4, 8, 12, 16, and 20

Title

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20

Description

The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Missing data were imputed using early escape rule (measurement value at Week 20 and 24 was set as missing). Here 'n' defined as number of participants who were analyzed at each specified timepoint, for each arm, respectively.

Time Frame

Baseline, Week 4, 8, 12, 16 and 20

Title

Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20

Description

Time Frame

Week 4, 8, 12, 16, and 20

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants must be classified as having nonradiographic axial spondyloarthritis (nr-AxSpA) based on 2009 Assessment of SpondyloArthritis International Society (ASAS) criteria Must have an age at nr-AxSpA onset of <= 45 years Must have at screening or active inflammation on magnetic resonance imaging (MRI) as evidenced by the central readers and no radiographic sacroiliitis that fulfills the 1984 modified New York Criteria Must have symptoms of active disease at screening and at baseline, as evidenced by both a BASDAI score of >= 4 and a visual analogue scale (VAS) score for total back pain of more than or equal to (>=) 4, each on a scale of 0 to 10 Exclusion Criteria: Have radiographic sacroiliitis fulfilling the 1984 modified New York Criteria Have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy Have received any systemic immunosuppressives or disease-modifying anti-rheumatic drug (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent Have received epidural, intra-articular, intramuscular (IM), or intravenous (IV) corticosteroids, including adrenocorticotropic hormone during the 4 weeks prior to first administration of study agent Have received prior biologic therapy other than anti-TNFα Have received more than 1 prior anti-TNFα agent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

City

Buenos Aires

Country

Argentina

City

Ciudad De Buenos Aires

Country

Argentina

City

Ciudad De La Plata

Country

Argentina

City

Ciudad De San Miguel De Tucuman

Country

Argentina

City

Cordoba

Country

Argentina

City

Geelong

Country

Australia

City

Hobart

Country

Australia

City

Kogarah

Country

Australia

City

Queensland

Country

Australia

City

Woodville South

Country

Australia

City

Woolloongabba

Country

Australia

City

Genk

Country

Belgium

City

Gent

Country

Belgium

City

Leuven

Country

Belgium

City

Liège

Country

Belgium

City

Merksem

Country

Belgium

City

Brno

Country

Czechia

City

Bruntal

Country

Czechia

City

Kladno

Country

Czechia

City

Ostrava

Country

Czechia

City

Pardubice

Country

Czechia

City

Prague 5

Country

Czechia

City

Praha 2

Country

Czechia

City

Praha 4

Country

Czechia

City

Uherske Hradiste

Country

Czechia

City

Zlin

Country

Czechia

City

Boulogne-Billancourt

Country

France

City

Chambray Les Tours

Country

France

City

Echirolles

Country

France

City

Montpellier, Herault

Country

France

City

Paris

Country

France

City

Toulouse

Country

France

City

Bad Nauheim

Country

Germany

City

Berlin

Country

Germany

City

Hamburg

Country

Germany

City

Hannover

Country

Germany

City

Herne

Country

Germany

City

Köln

Country

Germany

City

Olsberg

Country

Germany

City

Budapest

Country

Hungary

City

Debrecen

Country

Hungary

City

Esztergom

Country

Hungary

City

Kistarcsa

Country

Hungary

City

Nyíregyháza

Country

Hungary

City

Szolnok

Country

Hungary

City

Székesfehérvár

Country

Hungary

City

Veszprem

Country

Hungary

City

Gwangju

Country

Korea, Republic of

City

Incheon

Country

Korea, Republic of

City

Seoul

Country

Korea, Republic of

City

Chihuahua

Country

Mexico

City

Culiacan

Country

Mexico

City

Guadalajara

Country

Mexico

City

Mexico

Country

Mexico

City

Bydgoszcz

Country

Poland

City

Szczecin

Country

Poland

City

Torun

Country

Poland

City

Warszawa

Country

Poland

City

Wrocław

Country

Poland

City

Chelyabinsk

Country

Russian Federation

City

Chita

Country

Russian Federation

City

Kemerovo

Country

Russian Federation

City

Kirov

Country

Russian Federation

City

Moscow

Country

Russian Federation

City

Novosibirsk

Country

Russian Federation

City

Orenburg

Country

Russian Federation

City

Petrozavodsk

Country

Russian Federation

City

Sankt-Petersburg.

Country

Russian Federation

City

Saratov

Country

Russian Federation

City

St.Petersburg

Country

Russian Federation

City

Stavropol

Country

Russian Federation

City

Ulyanovsk

Country

Russian Federation

City

Zelenograd

Country

Russian Federation

City

Kaohsiung

Country

Taiwan

City

Taichung

Country

Taiwan

City

Tainan

Country

Taiwan

City

Taipei

Country

Taiwan

City

Taoyuan

Country

Taiwan

City

Ivano-Frankivsk

Country

Ukraine

City

Kharkiv

Country

Ukraine

City

Kyiv

Country

Ukraine

City

Lviv

Country

Ukraine

City

Odessa

Country

Ukraine

City

Ternopil

Country

Ukraine

City

Vinnytsya

Country

Ukraine

City

Zaporizhzhya

Country

Ukraine

City

Bath

Country

United Kingdom

City

Leeds

Country

United Kingdom

City

Leytonstone

Country

United Kingdom

City

London

Country

United Kingdom

City

Norwich

Country

United Kingdom

City

Staffordshire

Country

United Kingdom

City

Torquay

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

30225992

Citation

Deodhar A, Gensler LS, Sieper J, Clark M, Calderon C, Wang Y, Zhou Y, Leu JH, Campbell K, Sweet K, Harrison DD, Hsia EC, van der Heijde D. Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Feb;71(2):258-270. doi: 10.1002/art.40728. Epub 2018 Dec 29.

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An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis

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