Axial Spondyloarthritis
Conditions
Brief summary
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.
Interventions
DRUGTreatment
Sponsors
Merck Sharp & Dohme LLC
Professor Mikkel Østergaard
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* No contraindications for TNF inhibitor * No contraindications for MRI * No contraindications in participation in a study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50) | Week 52 | At least 50% reduction in BASDAI score at follow-up compared with BASDAI score at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BASDAI 50% or 2.0 Improvement | Week 16 | At least 50% decrease or at least an improvement of 2.0 in BASDAI, when measured on a scale with range 0-10. |
| Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII) | Week 16 | Decrease in ASDAS score at follow-up compared with ASDAS score at baseline of at least 1.1. |
| MRI Spine Remission | Week 16 | Maximum 1 disco-vertebral unit with inflammation present. |
| MRI-SPINE-50 | Week 16 | At least 50% reduction in Canada-Denmark (CANDEN) MRI spine inflammation score. |
Other
| Measure | Time frame | Description |
|---|---|---|
| MRI-PERIPH-50 | Week 16 | At least 50% reduction in MRI Peripheral Joints and Entheses Inflammation Index. MRIs of 74 peripheral joints were evaluated separately for synovitis and osteitis (i.e. bone marrow edema) and 30 peripheral entheses were evaluated separately for soft tissue inflammation and osteitis. All types of lesions (i.e. joint synovitis, joint osteitis, entheseal soft tissue inflammation and entheseal osteitis) were scored on a semi-quantitative scale of 0-2 ('none', 'mild', 'moderate to severe'). |
| MRI SI Joint Remission | Week 16 | Inflammation in 2 or fewer quadrants as assessed slice by slice across MRI slices that depict the cartilagenous compartment of the sacroiliac joints. |
| MRI Peripheral Joints and Entheses Inflammation Remission | Week 16 | A score of maximally 2 of the MRI Peripheral Joints and Entheses Inflammation Index. |
| MRI-SIJ-50 | Week 16 | At least 50% decrease in Spondyloarthritis Research Consortium of Canada (SPARCC) MRI sacroiliac joint inflammation index |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Treatment: Injection Golimumab 50 mg every month on the same date | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Non-compliance | 2 |
Baseline characteristics
| Characteristic | Treatment | — |
|---|---|---|
| Age, Continuous | 35 years | — |
| Ankylosing Spondylitis Disease Activity Score (ASDAS) | 3.6 units on a scale | — |
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Arthritis | 12 Participants | — |
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Dactylitis | 3 Participants | — |
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Elevated C-reactive protein | 34 Participants | — |
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Good response to NSAIDs | 38 Participants | — |
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Heel enthesitis | 12 Participants | — |
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Inflammatory back pain | 50 Participants | — |
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Inflammatory bowel disease | 2 Participants | — |
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Psoriasis | 6 Participants | — |
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Uveitis | 9 Participants | — |
| Assessment of Spondyloarthritis International Society criteria: Family history of spondyloarthritis | 15 Participants | — |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 6.2 units on a scale | — |
| Bath Ankylosing Spondylitis Functional Index (BASFI) | 4.6 units on a scale | — |
| Bath Ankylosing Spondylitis Metrology Index (BASMI) | 2 units on a scale | — |
| Body mass index | 24 kg/m2 | — |
| Canada-Denmark (CANDEN) Magnetic Resonance Imaging (MRI) Spine Erosion Score | 0 units on a scale | — |
| Canada-Denmark (CANDEN) Magnetic Resonance Imaging (MRI) Spine Fat Metaplasia Score | 3 units on a scale | — |
| Canada-Denmark (CANDEN) Magnetic Resonance Imaging (MRI) Spine Inflammation Index | 8 units on a scale | — |
| Canada-Denmark (CANDEN) Magnetic Resonance Imaging (MRI) Spine New Bone Formation Score | 0 units on a scale | — |
| Chest expansion | 4.0 cm | — |
| csDMARDs at baseline Leflunomide at baseline | 1 Participants | — |
| csDMARDs at baseline Methotrexate at baseline | 1 Participants | — |
| csDMARDs at baseline No csDMARDs | 49 Participants | — |
| csDMARDs at baseline Sulfasalazine at baseline | 2 Participants | — |
| Fulfilment of the radiographic part of the modified New York criteria | 33 Participants | — |
| hsCRP | 6.8 mg/L | — |
| Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) | 0 units on a scale | — |
| MRI Peripheral Joints and Entheses Inflammation Index | 7 units on a scale | — |
| Pain score | 6.9 units on a scale | — |
| Patient's global score | 7.5 units on a scale | — |
| Physician's global score | 4.9 units on a scale | — |
| Positive for HLA-B27 | 40 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 53 participants | — |
| Sex: Female, Male Female | 25 Participants | — |
| Sex: Female, Male Male | 28 Participants | — |
| SPARCC MRI Sacroiliac Joint Inflammation Index | 13 units on a scale | — |
| SPARCC MRI Sacroiliac Joint Structural Score - Ankylosis | 0 units on a scale | — |
| SPARCC MRI Sacroiliac Joint Structural Score - Backfill | 0 units on a scale | — |
| SPARCC MRI Sacroiliac Joint Structural Score - Erosion | 6 units on a scale | — |
| SPARCC MRI Sacroiliac Joint Structural Score - Fat | 2 units on a scale | — |
| SPARCC MRI Spine Inflammation Index | 8 units on a scale | — |
| Swollen joint count of 66 joints | 0 joints | — |
| Symptom duration | 5.1 years | — |
| Tender enthesis count | 3 entheses | — |
| Tender joint count of 68 joints | 0 joints | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 20 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
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
Time frame: Week 52
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50) | 31 Participants |
Secondary
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.
Time frame: Week 16
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII) | 40 Participants |
Secondary
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.
Time frame: Week 52
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII) | 34 Participants |
Secondary
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.
Time frame: Week 16
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | BASDAI 50% or 2.0 Improvement | 36 Participants |
Secondary
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.
Time frame: Week 52
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | BASDAI 50% or 2.0 Improvement | 36 Participants |
Secondary
MRI-SPINE-50
At least 50% reduction in Canada-Denmark (CANDEN) MRI spine inflammation score.
Time frame: Week 16
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | MRI-SPINE-50 | 30 Participants |
Secondary
MRI Spine Remission
Maximum 1 disco-vertebral unit with inflammation present.
Time frame: Week 16
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | MRI Spine Remission | 32 Participants |
Other Pre-specified
MRI-PERIPH-50
At least 50% reduction in MRI Peripheral Joints and Entheses Inflammation Index. MRIs of 74 peripheral joints were evaluated separately for synovitis and osteitis (i.e. bone marrow edema) and 30 peripheral entheses were evaluated separately for soft tissue inflammation and osteitis. All types of lesions (i.e. joint synovitis, joint osteitis, entheseal soft tissue inflammation and entheseal osteitis) were scored on a semi-quantitative scale of 0-2 ('none', 'mild', 'moderate to severe').
Time frame: Week 16
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | MRI-PERIPH-50 | 17 Participants |
Other Pre-specified
MRI Peripheral Joints and Entheses Inflammation Remission
A score of maximally 2 of the MRI Peripheral Joints and Entheses Inflammation Index.
Time frame: Week 16
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | MRI Peripheral Joints and Entheses Inflammation Remission | 16 Participants |
Other Pre-specified
MRI-SIJ-50
At least 50% decrease in Spondyloarthritis Research Consortium of Canada (SPARCC) MRI sacroiliac joint inflammation index
Time frame: Week 16
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | MRI-SIJ-50 | 29 Participants |
Other Pre-specified
MRI SI Joint Remission
Inflammation in 2 or fewer quadrants as assessed slice by slice across MRI slices that depict the cartilagenous compartment of the sacroiliac joints.
Time frame: Week 16
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | MRI SI Joint Remission | 24 Participants |