Trial Outcomes & Findings for Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation (NCT NCT03270501)
NCT ID: NCT03270501
Last Updated: 2025-02-11
Results Overview
The proportion of patients who completed the trial and achieved Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) \< 1.3 recorded on 2 consecutive visits with at least 12 weeks interval. ASDAS-CRP was measured at every study visit, i.e. baseline, week 2, week 4, week 16, week 28, week 40 and week 52. The study endpoint could earliest be achieved at visit week 28.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
64 participants
Primary outcome timeframe
Upon end of trial for individual patient, between 28 and 52 weeks.
Results posted on
2025-02-11
Participant Flow
Recruitment period: November 2017 - December 2022 across 3 centres: * Gent University Hospital * Imelda Hospital in Bonheiden * Jessa Hospital in Hasselt
Participant milestones
| Measure |
Arm 1: NSAIDs With Possible Step-up to Golimumab
NSAIDs: All patients fulfilling the inclusion criteria will be treated according to the current recommendations for the management of axial spondyloarthritis, i.e. with 2 courses of NSAIDs. If sufficient response is acheived, the patients will continue receiving NSAIDs and after sustained remission, the therapy will be stopped. If therapy with NSAIDs provides insufficient control of disease activity, switch to therapy with Golimumab will be made.
Golimumab: Patients who did not have a good treatment response to 2 NSAIDs, will be treated with golimumab sc 50mg/4 weeks. After sustained remission, the therapy will be stopped.
All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission.
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
Treatment Protocol Initiated
|
58
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Arm 1: NSAIDs With Possible Step-up to Golimumab
NSAIDs: All patients fulfilling the inclusion criteria will be treated according to the current recommendations for the management of axial spondyloarthritis, i.e. with 2 courses of NSAIDs. If sufficient response is acheived, the patients will continue receiving NSAIDs and after sustained remission, the therapy will be stopped. If therapy with NSAIDs provides insufficient control of disease activity, switch to therapy with Golimumab will be made.
Golimumab: Patients who did not have a good treatment response to 2 NSAIDs, will be treated with golimumab sc 50mg/4 weeks. After sustained remission, the therapy will be stopped.
All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission.
|
|---|---|
|
Overall Study
Screen failure
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation
Baseline characteristics by cohort
| Measure |
Arm 1: NSAIDs With Possible Step-up to Golimumab
n=58 Participants
NSAIDs: All patients fulfilling the inclusion criteria will be treated according to the current recommendations for the management of axial spondyloarthritis, i.e. with 2 courses of NSAIDs. If sufficient response is acheived, the patients will continue receiving NSAIDs and after sustained remission, the therapy will be stopped. If therapy with NSAIDs provides insufficient control of disease activity, switch to therapy with Golimumab will be made.
Golimumab: Patients who did not have a good treatment response to 2 NSAIDs, will be treated with golimumab sc 50mg/4 weeks. After sustained remission, the therapy will be stopped.
All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission.
|
|---|---|
|
Age, Continuous
|
28.2 years
STANDARD_DEVIATION 6.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP
|
3.0 units on a scale
STANDARD_DEVIATION 0.9 • n=99 Participants
|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
|
4.5 units on a scale
STANDARD_DEVIATION 1.5 • n=99 Participants
|
|
Bath Ankylosing Spondylitis Functional index (BASFI)
|
3.0 units on a scale
STANDARD_DEVIATION 2.2 • n=99 Participants
|
|
Positive for HLA-B27 (%)
|
50 Participants
n=99 Participants
|
|
Body mass index (BMI)
|
23.3 kg/m^2
STANDARD_DEVIATION 4.7 • n=99 Participants
|
|
Time from diagnosis
|
37 days
STANDARD_DEVIATION 18 • n=99 Participants
|
|
Assessment of SpondyloArthritis international Society (ASAS) criteria: Inflammatory Back Pain
|
51 Participants
n=99 Participants
|
|
Assessment of SpondyloArthritis international Society (ASAS) criteria: Arthritis
|
5 Participants
n=99 Participants
|
|
Assessment of SpondyloArthritis international Society (ASAS) criteria: Good response to NSAIDs
|
44 Participants
n=99 Participants
|
|
Assessment of SpondyloArthritis international Society (ASAS) criteria: Heel enthesitis
|
3 Participants
n=99 Participants
|
|
Assessment of SpondyloArthritis international Society (ASAS) criteria: Psoriasis
|
0 Participants
n=99 Participants
|
|
Assessment of SpondyloArthritis international Society (ASAS) criteria: Uveitis
|
0 Participants
n=99 Participants
|
|
Assessment of SpondyloArthritis international Society (ASAS) criteria: Dactylitis
|
0 Participants
n=99 Participants
|
|
Assessment of SpondyloArthritis international Society (ASAS) criteria: Inflammatory bowel disease
|
1 Participants
n=99 Participants
|
|
Assessment of SpondyloArthritis international Society criteria: Elevated C-reactive protein
|
24 Participants
n=99 Participants
|
|
Assessment of SpondyloArthritis international Society criteria: Family history of spondyloarthritis
|
22 Participants
n=99 Participants
|
|
CRP (mg/mL)
|
7.6 mg/mL
STANDARD_DEVIATION 11 • n=99 Participants
|
PRIMARY outcome
Timeframe: Upon end of trial for individual patient, between 28 and 52 weeks.Population: Patients who completed the trial
The proportion of patients who completed the trial and achieved Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) \< 1.3 recorded on 2 consecutive visits with at least 12 weeks interval. ASDAS-CRP was measured at every study visit, i.e. baseline, week 2, week 4, week 16, week 28, week 40 and week 52. The study endpoint could earliest be achieved at visit week 28.
Outcome measures
| Measure |
Arm 1: NSAIDs With Possible Step-up to Golimumab
n=55 Participants
NSAIDs: All patients fulfilling the inclusion criteria will be treated according to the current recommendations for the management of axial spondyloarthritis, i.e. with 2 courses of NSAIDs. If sufficient response is acheived, the patients will continue receiving NSAIDs and after sustained remission, the therapy will be stopped. If therapy with NSAIDs provides insufficient control of disease activity, switch to therapy with Golimumab will be made.
Golimumab: Patients who did not have a good treatment response to 2 NSAIDs, will be treated with golimumab sc 50mg/4 weeks. After sustained remission, the therapy will be stopped.
All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission.
|
|---|---|
|
Proportion of Patients Achieving Sustained Clinical Remission
|
34 Participants
|
SECONDARY outcome
Timeframe: At reaching primary outcome (between week 24 and week 52)Population: At baseline ileocolonoscopy, macroscopic lesions justifying a repeated ileocolonoscopy at a later timepoint were found in only 1 patient. For this patient, pathologic findings present at baseline assessment were also found during the second assessment.
According to the protocol, every patient underwent ileocolonoscopy at baseline to screen for macroscopic and microscopic (histopathologic analysis of endoscopic biopsies) signs of inflammation. If baseline ileocolonoscopy was protocolled as positive, the patient would undergo a second ileocolonoscopic assessment at the timepoint of reaching sustained clinical remission (study endpoint). The outcome measure is the proportion of patients with a negative second ileocolonoscopy.
Outcome measures
| Measure |
Arm 1: NSAIDs With Possible Step-up to Golimumab
n=1 Participants
NSAIDs: All patients fulfilling the inclusion criteria will be treated according to the current recommendations for the management of axial spondyloarthritis, i.e. with 2 courses of NSAIDs. If sufficient response is acheived, the patients will continue receiving NSAIDs and after sustained remission, the therapy will be stopped. If therapy with NSAIDs provides insufficient control of disease activity, switch to therapy with Golimumab will be made.
Golimumab: Patients who did not have a good treatment response to 2 NSAIDs, will be treated with golimumab sc 50mg/4 weeks. After sustained remission, the therapy will be stopped.
All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission.
|
|---|---|
|
The Proportion of Patients With Healed Lesions of the Intestinal Mucosa
|
0 Participants
|
Adverse Events
Arm 1: NSAIDs With Possible Step-up to Golimumab
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: NSAIDs With Possible Step-up to Golimumab
n=58 participants at risk
NSAIDs: All patients fulfilling the inclusion criteria will be treated according to the current recommendations for the management of axial spondyloarthritis, i.e. with 2 courses of NSAIDs. If sufficient response is acheived, the patients will continue receiving NSAIDs and after sustained remission, the therapy will be stopped. If therapy with NSAIDs provides insufficient control of disease activity, switch to therapy with Golimumab will be made.
Golimumab: Patients who did not have a good treatment response to 2 NSAIDs, will be treated with golimumab sc 50mg/4 weeks. After sustained remission, the therapy will be stopped.
All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
24.1%
14/58 • Number of events 16 • Adverse events data was collected between the first dose administration of trial medication and the last trial related activity (through study completion, between 24 weeks and 52 weeks). Medical events that occurred between signing of the Informed Consent and the first intake of trial medication were documented as medical and surgical history section and concomitant diseases.
All adverse events and serious adverse events were recorded in the patient's file and in the Case Report Form. Adverse Events were defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Gastroenteritis
|
6.9%
4/58 • Number of events 4 • Adverse events data was collected between the first dose administration of trial medication and the last trial related activity (through study completion, between 24 weeks and 52 weeks). Medical events that occurred between signing of the Informed Consent and the first intake of trial medication were documented as medical and surgical history section and concomitant diseases.
All adverse events and serious adverse events were recorded in the patient's file and in the Case Report Form. Adverse Events were defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
|
|
Infections and infestations
Otitis
|
5.2%
3/58 • Number of events 3 • Adverse events data was collected between the first dose administration of trial medication and the last trial related activity (through study completion, between 24 weeks and 52 weeks). Medical events that occurred between signing of the Informed Consent and the first intake of trial medication were documented as medical and surgical history section and concomitant diseases.
All adverse events and serious adverse events were recorded in the patient's file and in the Case Report Form. Adverse Events were defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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Additional Information
Professor Dirk Elewaut
Department of Rheumatology, Gent University Hospital
Phone: +32 9 332 22 30
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place