Back to resultsEffect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006) (GO-AHEAD)
Primary Purpose
Spondylitis, Ankylosing
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Golimumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Spondylitis, Ankylosing
Eligibility Criteria
Inclusion Criteria:
- Active axial spondyloarthritis with disease duration ≤5 years, and chronic back pain of ≥3 month duration
- Have either an inadequate response to 30 days of optimal daily doses of at least one non-steroidal anti-inflammatory drug (NSAID) or must be unable to receive a full 30 day maximal NSAID therapy because of intolerance, toxicity or contraindications to NSAIDs
- Females of child-bearing potential must use contraception
- No history of untreated latent or active tuberculosis
Exclusion Criteria:
- Fulfillment of modified New York criteria for ankylosing spondylitis
- Has ever received tumor necrosis factor (TNF)-α targeted therapy or any biological agents
- Any systemic inflammatory condition other than spondyloarthritis
- Serious infection within 2 months
- Any known malignancy or a history of malignancy within the previous 5 years
- Has or had a substance abuse (drug or alcohol) problem within the previous 2 years
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Golimumab→Golimumab
Placebo→Golimumab
Arm Description
In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16
The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=20% from Baseline and an absolute improvement from Baseline of >=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=20% worsening and an absolute worsening of >=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who experienced at least one AE were calculated for each part of the study.
Percentage of Participants Who Discontinued Study Drug Due to an AE
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who discontinued study drug due to an AE were calculated for each part of the study. Participants may have discontinued study drug without discontinuing from the study.
Secondary Outcome Measures
Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16
The ASAS consists of 4 domains: participant global assessment, total back pain, function (BASFI), and inflammation (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 100-mm VAS from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=40% from Baseline and an absolute improvement from Baseline of >=20 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=0% worsening and an absolute worsening of >=0 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 40 were calculated.
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16
The BASDAI is a summary of 6 participant-assessed 100-mm VAS for a) Fatigue, b) Spinal pain (overall), c) Peripheral arthritis, d) Enthesitis, e) Qualitative morning stiffness (intensity) and f) Quantitative morning stiffness (duration). Each VAS is measured as 0=none to 100=very severe, with a higher score indicating more severe symptoms. The BASDAI score is calculated as 0.2 time (a+b+c+d+[0.5 times e+f]) and can range from 0 to 100. The BASDAI 50 is defined as improvement by at least 50% from Baseline in the BASDAI score. The percentages of participants who achieved BASDAI 50 were calculated.
Percentage of Participants Achieving ASAS Partial Remission at Week 16
ASAS partial remission was defined as a VAS score of less than 20 mm in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16
Participants underwent MRI of the SI joints, without contrast, at Screening and Week 16 to assess the presence or absence of active inflammation of the SI joints. Scoring was based on 6 consecutive MRI slices through the SI joint. Each slice was divided into 4 quadrants. Each of the 48 quadrants was scored with respect to the presence of inflammation (0=no, 1=yes), yielding a maximum score of 48. Each slice was also assessed for the presence of a lesion exhibiting either intense signal or a depth >=1 cm anywhere within the SI joint of the 6 slices (0=no, 1=yes), yielding a maximum score of 24. Total SI joint scores could range from 0 to 72, with a higher score indicating more signs of disease.
Full Information
NCT ID
NCT01453725
First Posted
October 13, 2011
Last Updated
January 18, 2019
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Johnson & Johnson
1. Study Identification
Unique Protocol Identification Number
NCT01453725
Brief Title
Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)
Acronym
GO-AHEAD
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects With Active Axial Spondyloarthritis (Protocol No. P07642, Also Known as MK-8259-006-02).
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 13, 2012 (Actual)
Primary Completion Date
March 11, 2014 (Actual)
Study Completion Date
January 15, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
Johnson & Johnson
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in participants with active axial spondyloarthritis (axial SpA). In Part 1, participants were to receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline) and at Weeks 4, 8, and 12. During Part 1 of the study, participants were to not know the identity of the injection. In the Part 2 extension, all participants were to receive golimumab 50 mg subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2, the participants were to be told they were receiving active study drug. The primary hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks is superior to placebo as measured by the proportion of participants achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylitis, Ankylosing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Golimumab→Golimumab
Arm Type
Experimental
Arm Description
In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
Arm Title
Placebo→Golimumab
Arm Type
Placebo Comparator
Arm Description
In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
Intervention Type
Biological
Intervention Name(s)
Golimumab
Intervention Description
Golimumab 50 mg SC injection every 4 weeks
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo SC injection every 4 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16
Description
The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=20% from Baseline and an absolute improvement from Baseline of >=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=20% worsening and an absolute worsening of >=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.
Time Frame
Week 16
Title
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
Description
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who experienced at least one AE were calculated for each part of the study.
Time Frame
Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
Title
Percentage of Participants Who Discontinued Study Drug Due to an AE
Description
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who discontinued study drug due to an AE were calculated for each part of the study. Participants may have discontinued study drug without discontinuing from the study.
Time Frame
Up to 16 weeks for Part 1; Week 16 through up to 48 weeks for Part 2
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16
Description
The ASAS consists of 4 domains: participant global assessment, total back pain, function (BASFI), and inflammation (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 100-mm VAS from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=40% from Baseline and an absolute improvement from Baseline of >=20 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=0% worsening and an absolute worsening of >=0 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 40 were calculated.
Time Frame
Week 16
Title
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16
Description
The BASDAI is a summary of 6 participant-assessed 100-mm VAS for a) Fatigue, b) Spinal pain (overall), c) Peripheral arthritis, d) Enthesitis, e) Qualitative morning stiffness (intensity) and f) Quantitative morning stiffness (duration). Each VAS is measured as 0=none to 100=very severe, with a higher score indicating more severe symptoms. The BASDAI score is calculated as 0.2 time (a+b+c+d+[0.5 times e+f]) and can range from 0 to 100. The BASDAI 50 is defined as improvement by at least 50% from Baseline in the BASDAI score. The percentages of participants who achieved BASDAI 50 were calculated.
Time Frame
Week 16
Title
Percentage of Participants Achieving ASAS Partial Remission at Week 16
Description
ASAS partial remission was defined as a VAS score of less than 20 mm in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.
Time Frame
Week 16
Title
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16
Description
Participants underwent MRI of the SI joints, without contrast, at Screening and Week 16 to assess the presence or absence of active inflammation of the SI joints. Scoring was based on 6 consecutive MRI slices through the SI joint. Each slice was divided into 4 quadrants. Each of the 48 quadrants was scored with respect to the presence of inflammation (0=no, 1=yes), yielding a maximum score of 48. Each slice was also assessed for the presence of a lesion exhibiting either intense signal or a depth >=1 cm anywhere within the SI joint of the 6 slices (0=no, 1=yes), yielding a maximum score of 24. Total SI joint scores could range from 0 to 72, with a higher score indicating more signs of disease.
Time Frame
Baseline and Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active axial spondyloarthritis with disease duration ≤5 years, and chronic back pain of ≥3 month duration
Have either an inadequate response to 30 days of optimal daily doses of at least one non-steroidal anti-inflammatory drug (NSAID) or must be unable to receive a full 30 day maximal NSAID therapy because of intolerance, toxicity or contraindications to NSAIDs
Females of child-bearing potential must use contraception
No history of untreated latent or active tuberculosis
Exclusion Criteria:
Fulfillment of modified New York criteria for ankylosing spondylitis
Has ever received tumor necrosis factor (TNF)-α targeted therapy or any biological agents
Any systemic inflammatory condition other than spondyloarthritis
Serious infection within 2 months
Any known malignancy or a history of malignancy within the previous 5 years
Has or had a substance abuse (drug or alcohol) problem within the previous 2 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
26139307
Citation
Sieper J, van der Heijde D, Dougados M, Maksymowych WP, Scott BB, Boice JA, Berd Y, Bergman G, Curtis S, Tzontcheva A, Huyck S, Weng HH. A randomized, double-blind, placebo-controlled, sixteen-week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2015 Oct;67(10):2702-12. doi: 10.1002/art.39257.
Results Reference
result
PubMed Identifier
33878154
Citation
van der Heijde D, Dougados M, Maksymowych WP, Bergman G, Curtis SP, Tzontcheva A, Huyck S, Philip G, Sieper J. Long-term tolerability and efficacy of golimumab in active non-radiographic axial spondyloarthritis: results from open-label extension. Rheumatology (Oxford). 2022 Feb 2;61(2):617-627. doi: 10.1093/rheumatology/keab346.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/study.html?id=P07642&kw=8259-006&tab=access
Learn more about this trial
Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)
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