A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis

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

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.

Study Overview

• Status: Terminated
• Conditions: Axial Spondyloarthritis
• Intervention / Treatment: Drug: Placebo; Drug: Ustekinumab 45 mg; Drug: Ustekinumab 90 mg; Drug: Golimumab 50 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
  • Ciudad De La Plata, Argentina
  • Ciudad De San Miguel De Tucuman, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Cordoba, Argentina
• Belgium
  • Brussel, Belgium
  • Bruxelles, Belgium
  • Genk, Belgium
  • Gent, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Merksem (Antwerp), Belgium
• Brazil
  • Campinas, Brazil
  • Curitiba, Brazil
  • Goiânia, Brazil
  • Juiz de Fora, Brazil
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • Santo André, Brazil
  • Sao Paulo, Brazil
  • São Paulo, Brazil
• Bulgaria
  • Burgas, Bulgaria
  • Pleven, Bulgaria
  • Plovdiv, Bulgaria
  • Ruse, Bulgaria
  • Sofia, Bulgaria
• Canada
  • Quebec, Canada
  • Toronto, Canada
  • British Columbia
    • Victoria, British Columbia, Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada
  • Ontario
    • Windsor, Ontario, Canada
• Czechia
  • Bruntal, Czechia
  • Pardubice, Czechia
  • Prague 5, Czechia
  • Praha 2, Czechia
  • Praha 4, Czechia
  • Uherske Hradiste, Czechia
  • Zlin, Czechia
• France
  • Boulogne-Billancourt, France
  • Chambray Les Tours, France
  • Echirolles, France
  • Montpellier, Herault, France
  • Orleans, France
  • Paris, France
  • Rouen, France
  • Toulouse, France
• Germany
  • Bad Neuheim, Germany
  • Berlin, Germany
  • Gommern, Germany
  • Hamburg, Germany
  • Herne, Germany
  • Koeln, Germany
  • Olsberg, Germany
  • Ratingen, Germany
• Hungary
  • Budapest, Hungary
  • Debrecen, Hungary
  • Eger, Hungary
  • Kistarcsa, Hungary
  • Nyíregyháza, Hungary
  • Szolnok, Hungary
  • Székesfehérvár, Hungary
  • Veszprem, Hungary
• Korea, Republic of
  • Daegu, Korea, Republic of
  • Daejeon, Korea, Republic of
  • Gwangju, Korea, Republic of
  • JeonJu, Korea, Republic of
  • Seoul, Korea, Republic of
  • Suwon, Korea, Republic of
• Mexico
  • Culiacan, Mexico
  • Guadalajara, Mexico
  • Mexico City, Mexico
• Poland
  • Białystok, Poland
  • Bydgoszcz, Poland
  • Elblag, Poland
  • Nadarzyn, Poland
  • Szczecin, Poland
  • Torun, Poland
  • Warszawa, Poland
• Portugal
  • Almada, Portugal
  • Lisboa, Portugal
  • Porto, Portugal
• Russian Federation
  • Belgorod, Russian Federation
  • Chelyabinsk, Russian Federation
  • Chita, Russian Federation
  • Kazan, Russian Federation
  • Kemerovo, Russian Federation
  • Khanty-Mansiysk, Russian Federation
  • Kursk, Russian Federation
  • Moscow, Russian Federation
  • Nizhniy Novgorod, Russian Federation
  • Omsk, Russian Federation
  • Orenburg, Russian Federation
  • Petrozavodsk, Russian Federation
  • Pyatigorsk, Russian Federation
  • Saratov, Russian Federation
  • St. Petersburg, Russian Federation
  • St.Petersburg, Russian Federation
  • Ufa, Russian Federation
  • Zelenograd, Russian Federation
• Spain
  • A Coruna, Spain
  • Barcelona, Spain
  • Bilbao, Spain
  • Córdoba, Spain
  • L´Hospitalet de Llobregat, Spain
  • Madrid, Spain
  • Málaga, Spain
  • Sabadell, Spain
  • Santiago de Compostela, Spain
  • Sevilla, Spain
  • Valencia, Spain
• Taiwan
  • Changhua, Taiwan
  • Hualien, Taiwan
  • Kaohsiung, Taiwan
  • Taichung, Taiwan
  • Tainan, Taiwan
  • Taipei, Taiwan
  • Taoyuan, Taiwan
• Ukraine
  • Cherkasy, Ukraine
  • Ivano-Frankivsk, Ukraine
  • Kharkiv, Ukraine
  • Kyiv, Ukraine
  • Lviv, Ukraine
  • Odessa, Ukraine
  • Poltava, Ukraine
  • Ternopil, Ukraine
  • Uzhgorod, Ukraine
  • Vinnytsya, Ukraine
  • Zaporizhzhya, Ukraine
• United Kingdom
  • Bath, United Kingdom
  • Leytonstone, United Kingdom
  • London, United Kingdom
  • Peterborough, United Kingdom
  • Stoke on Trent, United Kingdom
  • Upton, United Kingdom
• United States
  • Arizona
    • Glendale, Arizona, United States
    • Peoria, Arizona, United States
    • Phoenix, Arizona, United States
  • California
    • Fremont, California, United States
  • Florida
    • Saint Petersburg, Florida, United States
    • Tampa, Florida, United States
  • Idaho
    • Meridian, Idaho, United States
  • Illinois
    • Chicago, Illinois, United States
  • Louisiana
    • Monroe, Louisiana, United States
  • Minnesota
    • Eagan, Minnesota, United States
  • New York
    • Orchard Park, New York, United States
  • Oregon
    • Portland, Oregon, United States
  • Pennsylvania
    • Duncansville, Pennsylvania, United States
    • Wyomissing, Pennsylvania, United States
  • Tennessee
    • Jackson, Tennessee, United States
  • Texas
    • Austin, Texas, United States
    • Mesquite, Texas, United States
  • Virginia
    • Arlington, Virginia, United States
  • Washington
    • Seattle, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1 (placebo); 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; Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16 in Group 1.; Drug: Ustekinumab 45 mg; 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.; Drug: Ustekinumab 90 mg; 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.; Drug: Golimumab 50 mg; 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.
Experimental: Group 2 (ustekinumab 45 mg); 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; 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.; Drug: Golimumab 50 mg; 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.
Experimental: Group 3 (ustekinumab 90 mg); 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.	Drug: Ustekinumab 90 mg; 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.; Drug: Golimumab 50 mg; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2015
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: May 6, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Golimumab; Ankylosing Spondylitis; Ustekinumab; STELARA
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Tumor Necrosis Factor Inhibitors; Golimumab; Ustekinumab
• Other Study ID Numbers: CR107099; CNTO1275AKS3002 (Other Identifier: Janssen Research & Development, LLC); 2015-000288-16 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No