Clinical trial NCT02186873: A Study of Golimumab in Participants With Active Ankylosing Spondylitis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
Golimumab
SIMPONI
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 drug assigned 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 of golimumab compared with placebo in participants with active ankylosing spondylitis. The study comprises of 4 phases: Screening phase (up to 6 weeks), Double-blind placebo-controlled phase (Week 0 to Week 16), Active treatment phase (Week 16 to Week 52), and Safety follow-up phase (8 weeks from last study drug administration). Total duration of the study will be 60 weeks per participant. Eligible Participants will be randomly assigned to either Treatment group 1: Placebo or Treatment group 2: Golimumab. Participants randomized to Placebo group, 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 mg/kg) at Weeks 16, 20 and thereafter every 8 weeks up to Week 52. Participants randomized to Golimumab group, 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 randomized to golimumab group will receive a placebo infusion to maintain the blind. The efficacy will be assessed primarily by measuring percentage of participants who achieve a 20 percent improvement from baseline in the assessment in ankylosing spondylitis (ASAS) at Week 16. Participant's safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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
* Additional protocol-defined inclusion criteria apply

Exclusion Criteria:

* 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
* Additional protocol-defined exclusion criteria apply

Primary outcomes:
measure: Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16
timeFrame: Week 16
measure: Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16
timeFrame: Week 16
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16
timeFrame: Week 16
measure: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16
timeFrame: Baseline and Week 16
Other outcomes:
Locations:
city: Glendale
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: La Palma
country: United States
state: California
city: Granger
country: United States
state: Indiana
city: Saint Louis
country: United States
state: Missouri
city: Orchard Park
country: United States
state: New York
city: Salisbury
country: United States
state: North Carolina
city: Middleburg Heights
country: United States
state: Ohio
city: Duncansville
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Maroochydore
country: Australia
city: Saint-John'S
country: Canada
state: Newfoundland and Labrador
city: St. John'S
country: Canada
state: Newfoundland and Labrador
city: Burlington
country: Canada
city: Trois-Rivieres
country: Canada
city: Bad Doberan
country: Germany
city: Berlin
country: Germany
city: Erfurt
country: Germany
city: Hamburg
country: Germany
city: Planegg
country: Germany
city: Ratingen
country: Germany
city: Zerbst
country: Germany
city: Ansan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Seongdong-Gu
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Chihuahua
country: Mexico
city: Bydgoszcz
country: Poland
city: Bytom
country: Poland
city: Nadarzyn
country: Poland
city: Nowa Sól
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: Smolensk
country: Russian Federation
city: Tver
country: Russian Federation
city: Chernihiv
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Kyiv
country: Ukraine
city: Odessa
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Deodhar 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.
citation: Husni 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.
citation: Reveille 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.
citation: Deodhar 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.