A Study to Evaluate the Efficacy and Safety of Ustekinuma... | NCT02438787 | Trialant
NCT02438787
Sponsor
Janssen Research & Development, LLC
Status
Terminated
Last Update Posted
Apr 29, 2025Actual
Enrollment
315Actual
Phase
Phase 3
Conditions
Axial Spondyloarthritis
Interventions
Placebo
Ustekinumab 45 mg
Ustekinumab 90 mg
Golimumab 50 mg
Countries
United States
Argentina
Belgium
Brazil
Bulgaria
Canada
Czechia
France
Germany
Hungary
Mexico
Poland
Portugal
Russia
South Korea
Spain
Taiwan
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02438787
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR107099
Secondary IDs
ID
Type
Description
Link
CNTO1275AKS3002
Other Identifier
Janssen Research & Development, LLC
2015-000288-16
EudraCT Number
Brief Title
A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic 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 Anti-TNF(Alpha) Refractory Subjects With Active Radiographic Axial Spondyloarthritis
Acronym
Not provided
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Apr 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
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.
Expanded Access Info
No
Start Date
Jul 31, 2015Actual
Primary Completion Date
Aug 31, 2017Actual
Completion Date
Aug 31, 2017Actual
First Submitted Date
May 6, 2015
First Submission Date that Met QC Criteria
May 6, 2015
First Posted Date
May 8, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 30, 2018
Results First Submitted that Met QC Criteria
Aug 30, 2018
Results First Posted Date
Oct 1, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 25, 2025
Last Update Posted Date
Apr 29, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic AxSpA.
Detailed Description
This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study. The study consists of 3 phases; Screening (up to 8 weeks), Treatment phase: placebo-controlled (Week 0 to 24) and active treatment (Week 24 to Week 52), and Safety Follow-up (up to 12 weeks). Participants will be randomly assigned to 1 of 3 treatment groups: placebo, ustekinumab 45 mg and ustekinumab 90 mg. The total duration of study will be up to 64 weeks. Participants will be primarily assessed for Assessment of SpondyloArthritis International Society (ASAS) 40 response at Week 24. Participants' safety will be monitored throughout the trial.
Conditions Module
Conditions
Axial Spondyloarthritis
Keywords
Ankylosing Spondylitis
Ustekinumab
Golimumab
STELARA
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
315Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1 (placebo)
Placebo Comparator
Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) will be re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52. Participants who meet EE criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52.
Drug: Placebo
Drug: Ustekinumab 45 mg
Drug: Ustekinumab 90 mg
Drug: Golimumab 50 mg
Group 2 (ustekinumab 45 mg)
Experimental
Ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 24, participants will receive placebo SC injection to maintain the blind. Participants who meet EE criteria (<10% improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.
Drug: Ustekinumab 45 mg
Drug: Golimumab 50 mg
Group 3 (ustekinumab 90 mg)
Experimental
Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 24, participants will receive placebo SC injection to maintain the blind. Participants who meet EE criteria (<10% improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16 in Group 1.
Group 1 (placebo)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24
ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (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(non responder imputation)] (missing responses at post baseline visit imputed as non-responder).
Week(W) 24
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Achieved an ASAS 20 Response at Week 24
ASAS 20 defined as improvement from baseline of >= 20% from baseline and with an 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 (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); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential 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).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must have a diagnosis of definite ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria. The radiographic criterion must be confirmed by a central xray reader and at least 1 clinical criterion must be met
Participants must have symptoms of active disease at screening and at baseline, as evidenced by both a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to (>=4) and a visual analog scale (VAS) score for total back pain of >=4, each on a scale of 0 to 10
Participants with elevated high sensitivity C-reactive protein (hsCRP) level of >=0.300 milligram per deciliter (mg/dL) at screening
Refractory by either lack of benefit or documented intolerance to 1 and no more than 1 anti-TNF(alpha) agent
Inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over a 4-week period in total with maximal doses of NSAID(s), or is unable to receive a full 4 weeks of maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs.
Participants with complete ankylosis of the spine are permitted to be included in the study, but will be limited to approximately 10 percent (%) of the study population
Exclusion Criteria:
Participants who have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, or Lyme disease
Participants who have received infliximab or infliximab biosimilar, within 12 weeks of the first study agent administration; have received adalimumab, adalimumab biosimilar, or certolizumab pegol within 6 weeks of the first study agent administration; have received etanercept or etanercept biosimilar within 6 weeks of the first study agent administration
Participants who have ever received golimumab
Participants who are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 5 months after receiving the last administration of study agent
Participants who have received any systemic immunosuppressives or disease-modifying antirheumatic drugs (DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ) within 4 weeks prior to first administration of study agent. Medications in these categories include, but are not limited to leflunomide, chloroquine, azathioprine, cyclosporine, mycophenolate mofetil, gold, and penicillamine
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Research & Development, LLC Clinical Trial
Kavanaugh A, Baraliakos X, Gao S, Chen W, Sweet K, Chakravarty SD, Song Q, Shawi M, Rahman P. Genetic and Molecular Distinctions Between Axial Psoriatic Arthritis and Radiographic Axial Spondyloarthritis: Post Hoc Analyses from Four Phase 3 Clinical Trials. Adv Ther. 2023 May;40(5):2439-2456. doi: 10.1007/s12325-023-02475-4. Epub 2023 Mar 30.
A total of 315 participants were randomized and treated (104 participants to placebo, 106 participants to ustekinumab 45 milligram (mg), and 105 participants to 90 mg).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met early escape (EE) criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 Weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Ustekinumab 45 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 2.
Group 1 (placebo)
Group 2 (ustekinumab 45 mg)
Ustekinumab 90 mg
Drug
Ustekinumab 90 mg SC injection at Weeks 24 and 28 followed by q12w dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 3.
Group 1 (placebo)
Group 3 (ustekinumab 90 mg)
Golimumab 50 mg
Drug
Participants who meet EE criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52 in Group 1, 2 and 3.
Group 1 (placebo)
Group 2 (ustekinumab 45 mg)
Group 3 (ustekinumab 90 mg)
Week 24
Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
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), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of 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).
Week 24
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score 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 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 (consider non-responder at Week 20 and 24).
Baseline and Week 24
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24
ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are 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*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (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).
Week 24
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Change from baseline in hsCRP 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).
Baseline, Week 4, 8, 12, 16, 20 and 24
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 are 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*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (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- responders).
Week 4, 8, 12, 16 and 20
Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20
ASAS 40 defined as improvement from baseline >= 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (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).
Week 4, 8, 12, 16 and 20
Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20
ASAS 20 defined as improvement from baseline of >= 20% and with an 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 (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); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential 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).
Week 4, 8, 12, 16 and 20
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20
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), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of 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).
Week 4, 8, 12, 16 and 20
Change From Baseline in BASFI Total Score 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 (consider non-responder at Week 20 and 24).
Baseline, Week 4, 8, 12, 16 and 20
Peoria
Arizona
United States
Phoenix
Arizona
United States
Fremont
California
United States
St. Petersburg
Florida
United States
Tampa
Florida
United States
Boise
Idaho
United States
Chicago
Illinois
United States
Monroe
Louisiana
United States
Eagan
Minnesota
United States
Orchard Park
New York
United States
Portland
Oregon
United States
Duncansville
Pennsylvania
United States
Wyomissing
Pennsylvania
United States
Jackson
Tennessee
United States
Austin
Texas
United States
Mesquite
Texas
United States
Arlington
Virginia
United States
Seattle
Washington
United States
Buenos Aires
Argentina
Ciudad de Buenos Aires
Argentina
Ciudad de La Plata
Argentina
Ciudad de San Miguel de Tucuman
Argentina
Córdoba
Argentina
Brussels
Belgium
Genk
Belgium
Ghent
Belgium
Leuven
Belgium
Liège
Belgium
Merksem (Antwerp)
Belgium
Campinas
Brazil
Curitiba
Brazil
Goiânia
Brazil
Juiz de Fora
Brazil
Porto Alegre
Brazil
Rio de Janeiro
Brazil
Santo André
Brazil
São Paulo
Brazil
Burgas
Bulgaria
Pleven
Bulgaria
Plovdiv
Bulgaria
Rousse
Bulgaria
Sofia
Bulgaria
Victoria
British Columbia
Canada
St. John's
Newfoundland and Labrador
Canada
Toronto
Ontario
Canada
Windsor
Ontario
Canada
Québec
Quebec
Canada
Bruntál
Czechia
Pardubice
Czechia
Prague
Czechia
Uherské Hradiště
Czechia
Zlín
Czechia
Boulogne-Billancourt
France
Chambray-lès-Tours
France
Échirolles
France
Montpellier
France
Orléans
France
Paris
France
Rouen
France
Toulouse
France
Bad Neuheim
Germany
Berlin
Germany
Cologne
Germany
Gommern
Germany
Hamburg
Germany
Herne
Germany
Olsberg
Germany
Ratingen
Germany
Budapest
Hungary
Debrecen
Hungary
Eger
Hungary
Kistarcsa
Hungary
Nyíregyháza
Hungary
Székesfehérvár
Hungary
Szolnok
Hungary
Veszprém
Hungary
Culiacán
Mexico
Guadalajara
Mexico
Mexico City
Mexico
Bialystok
Poland
Bydgoszcz
Poland
Elblag
Poland
Nadarzyn
Poland
Szczecin
Poland
Torun
Poland
Warsaw
Poland
Almada
Portugal
Lisbon
Portugal
Porto
Portugal
Belgorod
Russia
Chelyabinsk
Russia
Chita
Russia
Kazan'
Russia
Kemerovo
Russia
Khanty-Mansiysk
Russia
Kursk
Russia
Moscow
Russia
Nizhny Novgorod
Russia
Omsk
Russia
Orenburg
Russia
Petrozavodsk
Russia
Pyatigorsk
Russia
Saint Petersburg
Russia
Saratov
Russia
Ufa
Russia
Zelenograd
Russia
Daegu
South Korea
Daejeon
South Korea
Gwangju
South Korea
Jeonju
South Korea
Seoul
South Korea
Suwon
South Korea
A Coruña
Spain
Barcelona
Spain
Bilbao
Spain
Córdoba
Spain
L'Hospitalet de Llobregat
Spain
Madrid
Spain
Málaga
Spain
Sabadell
Spain
Santiago de Compostela
Spain
Seville
Spain
Valencia
Spain
Changhua
Taiwan
Hualien City
Taiwan
Kaohsiung City
Taiwan
Taichung
Taiwan
Tainan
Taiwan
Taipei
Taiwan
Taoyuan
Taiwan
Cherkasy
Ukraine
Ivano-Frankivsk
Ukraine
Kharkiv
Ukraine
Kyiv
Ukraine
Lviv
Ukraine
Odesa
Ukraine
Poltava
Ukraine
Ternopil
Ukraine
Uzhhorod
Ukraine
Vinnytsia
Ukraine
Zaporizhzhya
Ukraine
Bath
United Kingdom
Leytonstone
United Kingdom
London
United Kingdom
Peterborough
United Kingdom
Stoke-on-Trent
United Kingdom
Upton
United Kingdom
Derived
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.
FG001
Ustekinumab 45mg
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
FG002
Ustekinumab 90mg
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
FG000104 subjects
FG001106 subjects
FG002105 subjects
Early Escape at Week 16
FG00021 subjectsStudy discontinuation/completion reported under randomization group
FG00121 subjectsStudy discontinuation/completion reported under randomization group
FG00220 subjectsStudy discontinuation/completion reported under randomization group
Cross Over at Week 24
FG00043 subjectsOut of 43: crossed over to Ustekinumab 45 mg (n=21) and Ustekinumab 90 mg (n=22)
FG0010 subjects
FG0020 subjects
COMPLETED
FG00023 subjects
FG00123 subjects
FG00222 subjects
NOT COMPLETED
FG00081 subjects
FG00183 subjects
FG00283 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0022 subjects
Lack of Efficacy
FG0001 subjects
FG0012 subjects
FG0020 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
Withdrawal by Subject
FG00015 subjects
FG0017 subjects
FG00210 subjects
Study discontinued by sponsor
FG00064 subjects
FG00172 subjects
FG00269 subjects
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
Site terminated by sponsor
FG0000 subjects
FG0010 subjects
FG0021 subjects
Full Analysis Set (FAS) includes all participants who were randomized and received at least one administration of study agent.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
BG001
Ustekinumab 45mg
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
BG002
Ustekinumab 90mg
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000104
BG001106
BG002105
BG003315
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00040.8± 11.72
BG00141.4± 11.33
BG00241.5± 11.02
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00024
BG00118
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00012
BG00114
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG00014
BG00116
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
ARGENTINA
Title
Measurements
BG0002
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24
ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (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(non responder imputation)] (missing responses at post baseline visit imputed as non-responder).
Modified-FAS included FAS population, excluding who discontinued study agent prior to W24 due to trial termination,not had efficacy assessments at W24,but not excluding participants who met EE at W16/ had treatment failure prior to W24.Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Posted
Number
Percentage of participants
Week(W) 24
ID
Title
Description
OG000
Placebo
Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
OG001
Ustekinumab 45mg
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
OG002
Ustekinumab 90mg
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
Units
Counts
Participants
OG00073
OG00173
OG00267
Title
Denominators
Categories
Title
Measurements
OG00012.3
OG00119.2
OG00226.9
Secondary
Percentage of Participants Who Achieved an ASAS 20 Response at Week 24
ASAS 20 defined as improvement from baseline of >= 20% from baseline and with an 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 (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); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential 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).
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Secondary
Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
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), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of 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).
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score 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 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 (consider non-responder at Week 20 and 24).
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint.
Posted
Mean
Standard Deviation
Units on a scale
Baseline and Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Secondary
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24
ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are 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*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (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).
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Posted
Number
Percentage of participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Secondary
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Change from baseline in hsCRP 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).
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants analyzed for this endpoint at specific timepoints.
Posted
Mean
Standard Deviation
Milligrams per deciliter (mg/dL)
Baseline, Week 4, 8, 12, 16, 20 and 24
ID
Title
Description
OG000
Placebo
Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
OG001
Ustekinumab 45mg
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
Secondary
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 are 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*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (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- responders).
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Posted
Number
Percentage of participants
Week 4, 8, 12, 16 and 20
ID
Title
Description
OG000
Placebo
Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Secondary
Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20
ASAS 40 defined as improvement from baseline >= 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (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).
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Posted
Number
Percentage of participants
Week 4, 8, 12, 16 and 20
ID
Title
Description
OG000
Placebo
Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Secondary
Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20
ASAS 20 defined as improvement from baseline of >= 20% and with an 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 (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); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential 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).
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Posted
Number
Percentage of participants
Week 4, 8, 12, 16 and 20
ID
Title
Description
OG000
Placebo
Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Secondary
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20
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), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of 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).
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Posted
Number
Percentage of participants
Week 4, 8, 12, 16 and 20
ID
Title
Description
OG000
Placebo
Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Secondary
Change From Baseline in BASFI Total Score 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 (consider non-responder at Week 20 and 24).
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' (number analyzed) signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Posted
Mean
Standard Deviation
Units on a scale
Baseline, Week 4, 8, 12, 16 and 20
ID
Title
Description
OG000
Placebo
Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Time Frame
Up to Week 64
Description
The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants received placebo SC injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing. Included all participants, but adverse events for participants who early escaped at Week 16 or crossed over at Week 24 are only counted up to Week 16 or Week 24 respectively.
0
104
1
104
19
104
EG001
Placebo to Golimumab
Participants randomized to placebo SC who met early escape criteria and received golimumab from Week 16; adverse events are counted from early escape onward.
0
21
2
21
0
21
EG002
Placebo to Ustekinumab 45mg
Participants randomized to placebo SC and then rerandomized to receive ustekinumab 45 mg at Week 24; adverse events are counted from crossover onward.
0
21
0
21
2
21
EG003
Placebo to Ustekinumab 90mg
Participants randomized to placebo SC and then rerandomized to receive ustekinumab 90 mg at Week 24; adverse events are counted from crossover onward.
0
22
1
22
1
22
EG004
Ustekinumab 45mg Only
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing. Adverse events for participants who early escaped at Week 16 are only counted up to Week 16.
0
106
3
106
19
106
EG005
Ustekinumab 45mg to Golimumab
Participants randomized to ustekinumab 45 mg SC who met early escape criteria and received golimumab from Week 16; adverse events are counted from early escape onward.
0
21
1
21
7
21
EG006
Ustekinumab 90mg Only
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing. Adverse events for participants who early escaped at Week 16 are only counted up to Week 16.
0
105
6
105
18
105
EG007
Ustekinumab 90mg to Golimumab
Participants randomized to ustekinumab 90 mg SC who met early escape criteria and received golimumab from Week 16; adverse events are counted from early escape onward.
0
20
1
20
10
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial Ischaemia
Cardiac disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0011 affected21 at risk
EG0020 affected21 at risk
EG0030 affected22 at risk
EG0040 affected106 at risk
EG0050 affected21 at risk
EG0060 affected105 at risk
EG0070 affected20 at risk
Iritis
Eye disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Axial Spondyloarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0011 affected21 at risk
EG0020 affected21 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Renal Amyloidosis
Renal and urinary disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Uterine Polyp
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Uterine Prolapse
Reproductive system and breast disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG0030 affected22 at risk
EG0044 affected106 at risk
EG0051 affected21 at risk
EG0061 affected105 at risk
EG0071 affected20 at risk
Vitreous Haemorrhage
Eye disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0005 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Mouth Ulceration
Gastrointestinal disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0022 affected21 at risk
EG003
Injection Site Bruising
General disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0002 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Viral Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 20.0
Non-systematic Assessment
EG0004 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0006 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 20.0
Non-systematic Assessment
EG0005 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Spondylitis
Musculoskeletal and connective tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0001 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
Skin Disorder
Skin and subcutaneous tissue disorders
MedDRA Version 20.0
Non-systematic Assessment
EG0000 affected104 at risk
EG0010 affected21 at risk
EG0020 affected21 at risk
EG003
The study was discontinued before it was fully enrolled due to lack of efficacy of either dose of ustekinumab in the CNTO1275AKS3001 (NCT02437162) study.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
OG002
Ustekinumab 90mg
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
Units
Counts
Participants
OG00073
OG00173
OG00267
Title
Denominators
Categories
Title
Measurements
OG00027.4
OG00131.5
OG00237.3
OG001
Ustekinumab 45mg
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
OG002
Ustekinumab 90mg
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
Units
Counts
Participants
OG00073
OG00173
OG00267
Title
Denominators
Categories
Title
Measurements
OG00011.0
OG00115.1
OG00228.4
OG001
Ustekinumab 45mg
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
OG002
Ustekinumab 90mg
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
Units
Counts
Participants
OG00044
OG00144
OG00242
Title
Denominators
Categories
Title
Measurements
OG000-1.29± 2.219
OG001-1.74± 2.724
OG002-2.17± 2.438
OG001
Ustekinumab 45mg
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
OG002
Ustekinumab 90mg
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
Units
Counts
Participants
OG00073
OG00173
OG00267
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012.7
OG0023.0
OG002
Ustekinumab 90mg
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
Units
Counts
Participants
OG00073
OG00173
OG00267
Title
Denominators
Categories
Change at Week 4
ParticipantsOG00071
ParticipantsOG00169
ParticipantsOG00267
Title
Measurements
OG0000.12± 2.211
OG001-0.35± 2.171
OG002-0.12± 1.604
Change at Week 8
ParticipantsOG00069
ParticipantsOG00168
ParticipantsOG00265
Title
Measurements
OG000
Change at Week 12
ParticipantsOG00068
ParticipantsOG00168
ParticipantsOG00264
Title
Measurements
OG000
Change at Week 16
ParticipantsOG00066
ParticipantsOG00167
ParticipantsOG00264
Title
Measurements
OG000
Change at Week 20
ParticipantsOG00042
ParticipantsOG00145
ParticipantsOG00244
Title
Measurements
OG000
Change at Week 24
ParticipantsOG00043
ParticipantsOG00144
ParticipantsOG00243
Title
Measurements
OG000
OG001
Ustekinumab 45mg
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
OG002
Ustekinumab 90mg
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
Units
Counts
Participants
OG00073
OG00173
OG00267
Title
Denominators
Categories
Week 4
Title
Measurements
OG0000
OG0010
OG0020
Week 8
Title
Measurements
OG0000
OG0012.7
OG0020
Week 12
Title
Measurements
OG0000
OG0011.4
OG0023.0
Week 16
Title
Measurements
OG0000
OG0011.4
OG0023.0
Week 20
Title
Measurements
OG0001.4
OG0011.4
OG0021.5
OG001
Ustekinumab 45mg
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
OG002
Ustekinumab 90mg
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
Units
Counts
Participants
OG00073
OG00173
OG00267
Title
Denominators
Categories
Week 4
Title
Measurements
OG0006.8
OG0018.2
OG00211.9
Week 8
Title
Measurements
OG00011.0
OG00112.3
OG00216.4
Week 12
Title
Measurements
OG0006.8
OG00115.1
OG00219.4
Week 16
Title
Measurements
OG0009.6
OG00115.1
OG00220.9
Week 20
Title
Measurements
OG00012.3
OG00121.9
OG00225.4
OG001
Ustekinumab 45mg
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
OG002
Ustekinumab 90mg
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
Units
Counts
Participants
OG00073
OG00173
OG00267
Title
Denominators
Categories
Week 4
Title
Measurements
OG00019.2
OG00126.0
OG00231.3
Week 8
Title
Measurements
OG00020.5
OG00134.2
OG00229.9
Week 12
Title
Measurements
OG00024.7
OG00130.1
OG00232.8
Week 16
Title
Measurements
OG00023.3
OG00121.9
OG00235.8
Week 20
Title
Measurements
OG00028.8
OG00135.6
OG00241.8
OG001
Ustekinumab 45mg
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
OG002
Ustekinumab 90mg
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
Units
Counts
Participants
OG00073
OG00173
OG00267
Title
Denominators
Categories
Week 4
Title
Measurements
OG0005.5
OG0016.8
OG00211.9
Week 8
Title
Measurements
OG0008.2
OG00111.0
OG00213.4
Week 12
Title
Measurements
OG0004.1
OG00115.1
OG00211.9
Week 16
Title
Measurements
OG00011.0
OG00115.1
OG00216.4
Week 20
Title
Measurements
OG0008.2
OG00116.4
OG00219.4
OG001
Ustekinumab 45mg
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.
OG002
Ustekinumab 90mg
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24,participants were to receive placebo SC injection to maintain the blind.