A Study of Golimumab in Participants With Active Ankylosing Spondylitis
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing Spondylitis
3 other identifiers
interventional
208
9 countries
45
Brief Summary
The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral joints).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2014
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedStudy Start
First participant enrolled
September 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2016
CompletedResults Posted
Study results publicly available
November 13, 2017
CompletedOctober 30, 2025
October 1, 2025
1.3 years
July 8, 2014
October 11, 2017
October 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16
ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (\>=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI \[0=no functional impairment to 10= maximal impairment\]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale \[VAS\]), and an absence of deterioration (defined as \>=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.
Week 16
Secondary Outcomes (8)
Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16
Week 16
Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16
Week 16
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16
Baseline and Week 16
Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
Baseline and Week 16
Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16
Baseline and Week 16
- +3 more secondary outcomes
Study Arms (2)
Treatment Group 1: Placebo then Golimumab
EXPERIMENTALParticipants will receive intravenous infusions of placebo at Weeks 0, 4 and 12. At Week 16, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Weeks 16, 20 and thereafter every 8 weeks up to Week 52.
Treatment Group 2: Golimumab
EXPERIMENTALParticipants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 16, participants will receive a placebo infusion to maintain the blind.
Interventions
Eligibility Criteria
You may qualify if:
- Participants with diagnosis of definite ankylosing spondylitis for at least 3 months based on modified New York radiographic and clinical criteria
- Participants with symptoms of active disease at screening and at baseline
- Participant has either an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAID) over a 4 week period in total with maximal recommended doses of NSAIDs, or is unable to receive a full 4 weeks of maximal NSAID therapy because of intolerance, toxicity, or contraindications to NSAIDs
- Participants with C- reactive protein (CRP) level of greater than or equal to (\>=) 0.3 milligram per deciliter (mg/dL) at screening
You may not qualify if:
- Participant with other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy
- Pregnant or lactating females
- Participants with chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis
- Participants who had a serious infection (including but not limited to, hepatitis, pneumonia, sepsis, or pyelonephritis), or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study agent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Unknown Facility
Glendale, Arizona, United States
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Mesa, Arizona, United States
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La Palma, California, United States
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Granger, Indiana, United States
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St Louis, Missouri, United States
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Orchard Park, New York, United States
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Salisbury, North Carolina, United States
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Middleburg Heights, Ohio, United States
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Duncansville, Pennsylvania, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Maroochydore, Australia
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St. John's, Newfoundland and Labrador, Canada
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Burlington, Canada
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Trois-Rivières, Canada
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Bad Doberan, Germany
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Berlin, Germany
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Erfurt, Germany
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Hamburg, Germany
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Planegg, Germany
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Ratingen, Germany
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Zerbst, Germany
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Chihuahua City, Mexico
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Bydgoszcz, Poland
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Bytom, Poland
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Nadarzyn, Poland
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Nowa Sól, Poland
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Poznan, Poland
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Warsaw, Poland
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Moscow, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Smolensk, Russia
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Tver', Russia
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Ansan, South Korea
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Daegu, South Korea
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Gwangju, South Korea
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Seongdong-Gu, South Korea
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Seoul, South Korea
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Chernihiv, Ukraine
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Dnipropetrovsk, Ukraine
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Kyiv, Ukraine
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Odesa, Ukraine
Unknown Facility
Vinnytsia, Ukraine
Unknown Facility
Zaporizhzhia, Ukraine
Related Publications (5)
Deodhar A, Shiff NJ, Gong C, Chan EKH, Hsia EC, Lo KH, Akawung A, Kim L, Xu S, Reveille JD. Effect of Intravenous Golimumab on Fatigue and the Relationship with Clinical Response in Adults with Active Ankylosing Spondylitis in the Phase 3 GO-ALIVE Study. Rheumatol Ther. 2023 Aug;10(4):983-999. doi: 10.1007/s40744-023-00556-y. Epub 2023 Jun 15.
PMID: 37322274DERIVEDDeodhar AA, Shiff NJ, Gong C, Hsia EC, Lo KH, Kim L, Xu S, Reveille JD. Efficacy and Safety of Intravenous Golimumab in Ankylosing Spondylitis Patients With Early and Late Disease Through One Year of the GO-ALIVE Study. J Clin Rheumatol. 2022 Aug 1;28(5):270-277. doi: 10.1097/RHU.0000000000001853. Epub 2022 Jun 1.
PMID: 35653615DERIVEDHusni ME, Deodhar A, Schwartzman S, Chakravarty SD, Hsia EC, Leu JH, Zhou Y, Lo KH, Kavanaugh A. Pooled safety results across phase 3 randomized trials of intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Arthritis Res Ther. 2022 Mar 21;24(1):73. doi: 10.1186/s13075-022-02753-6.
PMID: 35313978DERIVEDReveille JD, Hwang MC, Danve A, Kafka S, Peterson S, Lo KH, Kim L, Hsia EC, Chan EKH, Deodhar A. The effect of intravenous golimumab on health-related quality of life and work productivity in adult patients with active ankylosing spondylitis: results of the phase 3 GO-ALIVE trial. Clin Rheumatol. 2021 Apr;40(4):1331-1341. doi: 10.1007/s10067-020-05342-7. Epub 2020 Sep 14.
PMID: 32926247DERIVEDDeodhar A, Reveille JD, Harrison DD, Kim L, Lo KH, Leu JH, Hsia EC. Safety and Efficacy of Golimumab Administered Intravenously in Adults with Ankylosing Spondylitis: Results through Week 28 of the GO-ALIVE Study. J Rheumatol. 2018 Mar;45(3):341-348. doi: 10.3899/jrheum.170487. Epub 2017 Dec 15.
PMID: 29247154DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clinical Development, Immunology General
- Organization
- Johnson&Johnson
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2014
First Posted
July 10, 2014
Study Start
September 3, 2014
Primary Completion
December 15, 2015
Study Completion
October 11, 2016
Last Updated
October 30, 2025
Results First Posted
November 13, 2017
Record last verified: 2025-10