Axial SpondyloarthritisPhase 3GO-GUTNCT03270501
Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation
A Phase 3 study testing Golimumab in people with Axial Spondyloarthritis, run by University Ghent at 3 sites in Belgium.
Trial summary
The hypothesis of the study is that the presence of (subclinical) gut inflammation at baseline in patients with early active axial spondyloarthritis predisposes to a more severe disease defined as more need to use anti-tumor necrosis factor α therapy and a shorter time to relapse after stopping anti-tumor necrosis… Read more about this study
- Who is it for?
- Ages 18 to 46 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Golimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesBelgium
- Study dates
- 8 Nov 2017to 14 Dec 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 46 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject must have a diagnosis of axSpA and classified according to ASAS criteria.
- Subject has at least 3 months and maximum 1 year (almost) daily chronic back pain.
- Subject has an active disease defined as a positive MRI (according to ASAS definition) or elevated CRP (in patients who are HLA-B27+) and an ASDAS score > 2.1 (at least high disease activity).
Who cannot join
- Full anti-inflammatory dose of NSAIDs for more than 4 weeks for the duration of the axSpA symptoms.
- Prior exposure to any biologic therapy with a potential therapeutic impact on SpA, including anti-TNF therapy.
- Exposure to disease-modifying drugs (DMARDSs; i.e. methotrexate and sulfasalazine) in the last 3 months before the ileocolonoscopy.
- Exposure to systemic corticosteroid treatment in the last 14 days before the ileocolonoscopy.
- Infection(s) requiring treatment with intravenous antibiotics/antivirals/antifungals within 30 days prior to the baseline visit or oral antibiotics/antivirals/antifungals within 14 days prior to the baseline visit.
- Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.
Show all 19Show fewer
- History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease.
- History of listeriosis, histoplasmosis, chronic of active hepatitis B infection, hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis.
- Have a history of, or concurrent, chronic heart failure, including medically controlled, asymptomatic congestive heart failure.
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
- Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months prior to the first administration of study agent, during the trial, or within 6 months after the last administration of study agent.
- Positive pregnancy test at screening.
- Female subjects who are breast-feeding or considering becoming pregnant during the study.
- Female subjects who do not use contraceptives.
- History of clinically significant drug or alcohol abuse in the last 12 months.
- Clinically significant abnormal screening laboratory results as evaluated by the investigator.
- Positive rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) antibody at screening if the titers are crossing 3 times the upper limit of the normal.
- Subject with diagnosis and current symptoms of fibromyalgia.
- Any medical or psychological condition that, in the opinion of the investigator, could jeopardize or compromise the subject's ability to participate in this study.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Imelda Bonheiden
Bonheiden, Antwerpen, 2820
Ghent University Hospital
Ghent, B - Belgium, 9000
Reuma Instituut Hasselt
Hasselt, Limburg, 3500
About this study
Official title: Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation, an Early Remission Induction Study
The hypothesis of the study is that the presence of (subclinical) gut inflammation at baseline in patients with early active axial spondyloarthritis predisposes to a more severe disease defined as more need to use anti-tumor necrosis factor α therapy and a shorter time to relapse after stopping anti-tumor necrosis factor α therapy after obtaining sustained clinical remission. Overall, the investigators hypothesize that subclinical gut inflammation is an important predictor in therapy response and outcome. These data could provide better insights into the complex interactions between gut and joint inflammation and guide the physicians in the therapeutic approach.
- Conditions
- Axial Spondyloarthritis
- Being tested
- Golimumab
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GolimumabDrug
Also called ileocoloscopy
Axial spondyloarthritis patients who don't have a good treatment response on 2 NSAIDs, will be treated with golimumab. After remission, the therapy will be stopped.
All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Golimumab | Experimental | Not described Receives: Drug: Golimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Achieving Sustained Clinical Remission
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.
Measured: Upon end of trial for individual patient, between 28 and 52 weeks.
Secondary outcomes (1)
The Proportion of Patients With Healed Lesions of the Intestinal Mucosa
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.
Measured: At reaching primary outcome (between week 24 and week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start8 Nov 2017
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, the Flanders Institute for Biotechnology
- Responsible party
- Sponsor
- Investigators
- Dirk Elewaut, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270501
- Sponsor's protocol ID
- GO-GUT trial
- Acronym
- GO-GUT
- Status last verified
- Jul 2024
- First submitted
- 18 Aug 2017
- Last updated
- 11 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011 Jun 18;377(9783):2127-37. doi: 10.1016/S0140-6736(11)60071-8.
PubMed 21684383Mielants H, Veys EM, Cuvelier C, De Vos M, Botelberghe L. HLA-B27 related arthritis and bowel inflammation. Part 2. Ileocolonoscopy and bowel histology in patients with HLA-B27 related arthritis. J Rheumatol. 1985 Apr;12(2):294-8.
PubMed 3875721Van Praet L, Van den Bosch FE, Jacques P, Carron P, Jans L, Colman R, Glorieus E, Peeters H, Mielants H, De Vos M, Cuvelier C, Elewaut D. Microscopic gut inflammation in axial spondyloarthritis: a multiparametric predictive model. Ann Rheum Dis. 2013 Mar;72(3):414-7. doi: 10.1136/annrheumdis-2012-202135. Epub 2012 Nov 8.
PubMed 23139267Lukasik Z, De Craemer AS, Renson T, Deroo L, Varkas G, de Hooge M, Lenaerts J, Hoorens A, Cuvelier C, Lobaton Ortega T, Carron P, Van den Bosch F, Elewaut D. Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation: An Early Remission Induction Study. Arthritis Rheumatol. 2026 Jan;78(1):119-130. doi: 10.1002/art.43283. Epub 2025 Nov 11.
PubMed 40524500
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation, an Early Remission Induction Study
- ClinicalTrials.gov ID
- NCT03270501
- Acronym / sponsor ID
- GO-GUT / GO-GUT trial
- Conditions
- Axial Spondyloarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, the Flanders Institute for Biotechnology
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Posted 11 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of the study is that the presence of (subclinical) gut inflammation at baseline in patients with early active axial spondyloarthritis predisposes to a more severe disease defined as more need to use anti-tumor necrosis factor α therapy and a shorter time to relapse after stopping anti-tumor necrosis factor α therapy after obtaining sustained clinical remission. Overall, the investigators hypothesize that subclinical gut inflammation is an important predictor in therapy response and outcome. These data could provide better insights into the complex interactions between gut and joint inflammation and guide the physicians in the therapeutic approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Golimumab | Experimental | Drug: Golimumab |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject must have a diagnosis of axSpA and classified according to ASAS criteria.
- Subject has at least 3 months and maximum 1 year (almost) daily chronic back pain.
- Subject has an active disease defined as a positive MRI (according to ASAS definition) or elevated CRP (in patients who are HLA-B27+) and an ASDAS score > 2.1 (at least high disease activity).
Key exclusion criteria (19 listed)
- Full anti-inflammatory dose of NSAIDs for more than 4 weeks for the duration of the axSpA symptoms.
- Prior exposure to any biologic therapy with a potential therapeutic impact on SpA, including anti-TNF therapy.
- Exposure to disease-modifying drugs (DMARDSs; i.e. methotrexate and sulfasalazine) in the last 3 months before the ileocolonoscopy.
- Exposure to systemic corticosteroid treatment in the last 14 days before the ileocolonoscopy.
- Infection(s) requiring treatment with intravenous antibiotics/antivirals/antifungals within 30 days prior to the baseline visit or oral antibiotics/antivirals/antifungals within 14 days prior to the baseline visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GolimumabAlso: ileocoloscopyAxial spondyloarthritis patients who don't have a good treatment response on 2 NSAIDs, will be treated with golimumab. After remission, the therapy will be stopped. All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission. | Drug | Arm 1: Golimumab |
Primary outcome
Proportion of Patients Achieving Sustained Clinical Remission
Time frame: Upon end of trial for individual patient, between 28 and 52 weeks.
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.
1 secondary outcome
The Proportion of Patients With Healed Lesions of the Intestinal Mucosa
Time frame: At reaching primary outcome (between week 24 and week 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21684383Dougados M, Baeten D. Spondyloarthritis. Lancet. 2011 Jun 18;377(9783):2127-37. doi: 10.1016/S0140-6736(11)60071-8.
- Background: PubMed 3875721Mielants H, Veys EM, Cuvelier C, De Vos M, Botelberghe L. HLA-B27 related arthritis and bowel inflammation. Part 2. Ileocolonoscopy and bowel histology in patients with HLA-B27 related arthritis. J Rheumatol. 1985 Apr;12(2):294-8.
- Background: PubMed 23139267Van Praet L, Van den Bosch FE, Jacques P, Carron P, Jans L, Colman R, Glorieus E, Peeters H, Mielants H, De Vos M, Cuvelier C, Elewaut D. Microscopic gut inflammation in axial spondyloarthritis: a multiparametric predictive model. Ann Rheum Dis. 2013 Mar;72(3):414-7. doi: 10.1136/annrheumdis-2012-202135. Epub 2012 Nov 8.
- Derived from this study: PubMed 40524500Lukasik Z, De Craemer AS, Renson T, Deroo L, Varkas G, de Hooge M, Lenaerts J, Hoorens A, Cuvelier C, Lobaton Ortega T, Carron P, Van den Bosch F, Elewaut D. Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation: An Early Remission Induction Study. Arthritis Rheumatol. 2026 Jan;78(1):119-130. doi: 10.1002/art.43283. Epub 2025 Nov 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk Elewaut principal investigator
University Ghent
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Golimumab in people with Axial Spondyloarthritis, run by University Ghent at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Achieving Sustained Clinical Remission (time frame: Upon end of trial for individual patient, between 28 and 52 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03270501, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.