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A Study of Golimumab in Participants With Active Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Golimumab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing Spondylitis, Golimumab, SIMPONI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Group 1: Placebo then Golimumab

Treatment Group 2: Golimumab

Arm Description

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16
An ASAS 40 response is defined as >=40% improvement from baseline in 3 of 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 2 (0-10 cm VAS), and no deterioration in the remaining domain.
Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16
The BASDAI is a self-assessment tool to determine disease activity using a VAS of 0-10 cm (0=none and 10=very severe) participant's answered 6 questions measuring fatigue, spinal pain, joint pain, enthesitis, and morning stiffness. The final BASDAI is calculated as a mean of individual questions with a final score range of 0 to 10 cm; 0=best and 10=worst.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16
The BASFI is a participant's self-assessment of physical function represented as a mean of 10 questions, each question rated on VAS 0 to 10 cm (VAS 0 to 10 cm; 0=easy to 10=impossible), 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life.
Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score (vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.
Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16
The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.
Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16
Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation.
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16
The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of "yes" on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL.
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS.

Full Information

First Posted
July 8, 2014
Last Updated
November 28, 2017
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02186873
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 3, 2014 (Actual)
Primary Completion Date
December 15, 2015 (Actual)
Study Completion Date
October 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
Ankylosing Spondylitis, Golimumab, SIMPONI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group 1: Placebo then Golimumab
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Treatment Group 2: Golimumab
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo.
Intervention Type
Drug
Intervention Name(s)
Golimumab
Intervention Description
Participants will receive 2mg/kg of intravenous infusions of golimumab .
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16
Description
An ASAS 40 response is defined as >=40% improvement from baseline in 3 of 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 2 (0-10 cm VAS), and no deterioration in the remaining domain.
Time Frame
Week 16
Title
Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16
Description
The BASDAI is a self-assessment tool to determine disease activity using a VAS of 0-10 cm (0=none and 10=very severe) participant's answered 6 questions measuring fatigue, spinal pain, joint pain, enthesitis, and morning stiffness. The final BASDAI is calculated as a mean of individual questions with a final score range of 0 to 10 cm; 0=best and 10=worst.
Time Frame
Week 16
Title
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16
Description
The BASFI is a participant's self-assessment of physical function represented as a mean of 10 questions, each question rated on VAS 0 to 10 cm (VAS 0 to 10 cm; 0=easy to 10=impossible), 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life.
Time Frame
Baseline and Week 16
Title
Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
Description
The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score (vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.
Time Frame
Baseline and Week 16
Title
Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16
Description
The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.
Time Frame
Baseline and Week 16
Title
Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16
Description
Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation.
Time Frame
Week 16
Title
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16
Description
The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of "yes" on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL.
Time Frame
Baseline and Week 16
Title
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16
Description
BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS.
Time Frame
Baseline and Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Glendale
State/Province
Arizona
Country
United States
City
Mesa
State/Province
Arizona
Country
United States
City
La Palma
State/Province
California
Country
United States
City
Granger
State/Province
Indiana
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Orchard Park
State/Province
New York
Country
United States
City
Salisbury
State/Province
North Carolina
Country
United States
City
Middleburg Heights
State/Province
Ohio
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Maroochydore
Country
Australia
City
Saint-John'S
State/Province
Newfoundland and Labrador
Country
Canada
City
St. John'S
State/Province
Newfoundland and Labrador
Country
Canada
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35653615
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.
Results Reference
derived
PubMed Identifier
35313978
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.
Results Reference
derived
PubMed Identifier
32926247
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.
Results Reference
derived
PubMed Identifier
29247154
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. Erratum In: J Rheumatol. 2018 Feb;45(2):291.
Results Reference
derived

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A Study of Golimumab in Participants With Active Ankylosing Spondylitis

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