Axial SpondyloarthritisMANGONCT02011386

Novel MRI ANd Biomarkers in GOlimumab-treated Patients With Axial Spondyloarthritis

An observational study of Axial Spondyloarthritis, run by Professor Mikkel Østergaard at 6 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Axial Spondyloarthritis
What is being tested?: Treatment
Type of treatment: Injection or infusion
How many people: 53 participants
Where: 6 sitesDenmark
Study dates: Feb 2013to 14 Feb 2017
Phase: Observational
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with axial spondyloarthritis with moderate to high disease activity (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at least 40 mm), who are going to start treatment with TNF inhibitor.

Who may be able to join

Axial spondyloarthritis according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axial spondyloarthritis
Sacroiliitis on conventional X-rays or Magnetic Resonance Imaging (MRI).
Disease activity assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >40 mm despite treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAID).
Clinical indication for tumor necrosis factor (TNF) inhibitor treatment by the treating physician.

Who cannot join

No contraindications for TNF inhibitor
No contraindications for MRI
No contraindications in participation in a study

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Denmark6 sites

Frederiksberg Bispebjerg Hospitals, Dep. of Rheumatology
Copenhagen, 2000
Glostrup Hospital, Dep. of Rheumatology
Copenhagen, 2600
Herlev Hospital, Dep. of Radiology
Copenhagen, 2730
Gentofte Hospital, Dep. of Rheumatology
Copenhagen, 2900
Nordsjællands Hospital Hillerød, Dep. of Rheumatology
Hillerød, 3400
Køge Hospital, Dep. of Rheumatology
Køge, 4600

Other trials in Denmark

About this study

Official title: Improved Monitoring and Prediction of Clinical Response and Disease Course During Golimumab Therapy of Patients With Axial Spondyloarthritis

The study investigates different criteria for remission based on MRI and circulating biomarkers for inflammation, cartilage, connective tissue and bone turnover in patients with axial spondyloarthritis treated with Golimumab. Furthermore, the study also investigates factors that affect disease activity, function and participation by use of different questionnaires.

Conditions: Axial Spondyloarthritis
Being tested: Treatment
Medical subject headings: Axial Spondyloarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TreatmentDrug
Also called Treatment: Injection Golimumab 50 mg every month on the same date

Study groups in NCT02011386
Study group	Role	What they receive
Treatment		Treatment: Injection Golimumab 50 mg every month on the same date Receives: Drug: Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50)
At least 50% reduction in BASDAI score at follow-up compared with BASDAI score at baseline
Measured: Week 52

Secondary outcomes (6)

BASDAI 50% or 2.0 Improvement
At least 50% decrease or at least an improvement of 2.0 in BASDAI, when measured on a scale with range 0-10.
Measured: Week 16
BASDAI 50% or 2.0 Improvement
At least 50% decrease or at least an improvement of 2.0 in BASDAI, when measured on a scale with range 0-10.
Measured: Week 52
Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)
Decrease in ASDAS score at follow-up compared with ASDAS score at baseline of at least 1.1.
Measured: Week 16
Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)
Decrease in ASDAS score at follow-up compared with ASDAS score at baseline of at least 1.1.
Measured: Week 52
MRI Spine Remission
Maximum 1 disco-vertebral unit with inflammation present.
Measured: Week 16
MRI-SPINE-50
At least 50% reduction in Canada-Denmark (CANDEN) MRI spine inflammation score.
Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201314 Feb 2017

First posted13 Dec 2013 (estimated)
Study startFeb 2013
Primary completion14 Feb 2017
Study completion14 Feb 2017

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 (3)Papers the sponsor has linked to this study.
Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02011386
Sponsor's protocol ID: MANGO
Acronym: MANGO
Status last verified: Jul 2020
First submitted: 6 Dec 2013
Last updated: 17 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Lorincz M, Ostergaard M, Wetterslev M, Sorensen IJ, Madsen OR, Christiansen SN, Hetland ML, Bakkegaard M, Klarlund M, Duer A, Boesen M, Gosvig KK, Pedersen SJ. Construct validity and responsiveness of ASAS Health Index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritis. RMD Open. 2024 Dec 20;10(4):e004948. doi: 10.1136/rmdopen-2024-004948.
PubMed 39794273
Krabbe S, Eshed I, Sorensen IJ, Moller J, Jensen B, Madsen OR, Klarlund M, Pedersen SJ, Ostergaard M. Novel whole-body magnetic resonance imaging response and remission criteria document diminished inflammation during golimumab treatment in axial spondyloarthritis. Rheumatology (Oxford). 2020 Nov 1;59(11):3358-3368. doi: 10.1093/rheumatology/keaa153.
PubMed 32310294
Krabbe S, Ostergaard M, Pedersen SJ, Weber U, Krober G, Makysmowych W, Lambert RGW. Canada-Denmark MRI scoring system of the spine in patients with axial spondyloarthritis: updated definitions, scoring rules and inter-reader reliability in a multiple reader setting. RMD Open. 2019 Oct 13;5(2):e001057. doi: 10.1136/rmdopen-2019-001057. eCollection 2019.
PubMed 31673422

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy

All Axial Spondyloarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improved Monitoring and Prediction of Clinical Response and Disease Course During Golimumab Therapy of Patients With Axial Spondyloarthritis
ClinicalTrials.gov ID: NCT02011386
Acronym / sponsor ID: MANGO / MANGO
Conditions: Axial Spondyloarthritis
Study type: Observational
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Professor Mikkel ØstergaardUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Feb 2013 (actual)
Primary completion: 14 Feb 2017 (actual)
Study completion: 14 Feb 2017 (actual)
First posted: 13 Dec 2013 (estimated)
Results: Posted 17 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Treatment	–	Drug: TreatmentTreatment: Injection Golimumab 50 mg every month on the same date

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with axial spondyloarthritis with moderate to high disease activity (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at least 40 mm), who are going to start treatment with TNF inhibitor.

Key inclusion criteria (4 listed)

Axial spondyloarthritis according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axial spondyloarthritis
Sacroiliitis on conventional X-rays or Magnetic Resonance Imaging (MRI).
Disease activity assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >40 mm despite treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAID).
Clinical indication for tumor necrosis factor (TNF) inhibitor treatment by the treating physician.

Key exclusion criteria (3 listed)

No contraindications for TNF inhibitor
No contraindications for MRI
No contraindications in participation in a study

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
TreatmentAlso: Treatment: Injection Golimumab 50 mg every month on the same date	Drug	Treatment

Primary outcome

Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50)
Time frame: Week 52
At least 50% reduction in BASDAI score at follow-up compared with BASDAI score at baseline

6 secondary outcomes

BASDAI 50% or 2.0 Improvement
Time frame: Week 16
BASDAI 50% or 2.0 Improvement
Time frame: Week 52
Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)
Time frame: Week 16
Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)
Time frame: Week 52
MRI Spine Remission
Time frame: Week 16
MRI-SPINE-50
Time frame: Week 16

Results and safety

Results posted to the registry on 17 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	53	48

Primary outcome: Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50)

Time frame: Week 52. Count of participants. Unit: Participants

Measure	Treatment n = 53
Value	31

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the date of start of golimumab treatment and until the date of the week 52 visit or the date of early termination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	0 of 53 (0%)	20 of 53 (37.7%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39794273Lorincz M, Ostergaard M, Wetterslev M, Sorensen IJ, Madsen OR, Christiansen SN, Hetland ML, Bakkegaard M, Klarlund M, Duer A, Boesen M, Gosvig KK, Pedersen SJ. Construct validity and responsiveness of ASAS Health Index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritis. RMD Open. 2024 Dec 20;10(4):e004948. doi: 10.1136/rmdopen-2024-004948.
Derived from this study: PubMed 32310294Krabbe S, Eshed I, Sorensen IJ, Moller J, Jensen B, Madsen OR, Klarlund M, Pedersen SJ, Ostergaard M. Novel whole-body magnetic resonance imaging response and remission criteria document diminished inflammation during golimumab treatment in axial spondyloarthritis. Rheumatology (Oxford). 2020 Nov 1;59(11):3358-3368. doi: 10.1093/rheumatology/keaa153.
Derived from this study: PubMed 31673422Krabbe S, Ostergaard M, Pedersen SJ, Weber U, Krober G, Makysmowych W, Lambert RGW. Canada-Denmark MRI scoring system of the spine in patients with axial spondyloarthritis: updated definitions, scoring rules and inter-reader reliability in a multiple reader setting. RMD Open. 2019 Oct 13;5(2):e001057. doi: 10.1136/rmdopen-2019-001057. eCollection 2019.

Related trials for Axial Spondyloarthritis

Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy

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.

Mikkel Østergaard, Professor principal investigator

Glostrup Hospital, University of Copenhagen

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Axial Spondyloarthritis, run by Professor Mikkel Østergaard at 6 sites in Denmark.

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 4 inclusion and 3 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 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Denmark. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2020). 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?

Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50) (time frame: Week 52). 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 NCT02011386, which also lists 3 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 17 Aug 2020.