Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Treatment: Injection Golimumab 50 mg every month on the same date |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| MRI-SIJ-50 | At least 50% decrease in Spondyloarthritis Research Consortium of Canada (SPARCC) MRI sacroiliac joint inflammation index | Week 16 |
| 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'). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mikkel Østergaard, Professor | Glostrup Hospital, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frederiksberg Bispebjerg Hospitals, Dep. of Rheumatology | Copenhagen | 2000 | Denmark | |||
| Glostrup Hospital, Dep. of Rheumatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39794273 | Derived | 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. | |
| 32310294 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Treatment: Injection Golimumab 50 mg every month on the same date |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Treatment: Injection Golimumab 50 mg every month on the same date |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Week 52 |
|
|
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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Treatment: Injection Golimumab 50 mg every month on the same date | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Mikkel Østergaard, MD, PhD, DMSc | Rigshospitalet, Denmark | +45 38633014 | mo@dadlnet.dk |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2016 | May 26, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | Week 52 |
| MRI Spine Remission | Maximum 1 disco-vertebral unit with inflammation present. | Week 16 |
| MRI-SPINE-50 | At least 50% reduction in Canada-Denmark (CANDEN) MRI spine inflammation score. | Week 16 |
| Week 16 |
| 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. | Week 16 |
| MRI Peripheral Joints and Entheses Inflammation Remission | A score of maximally 2 of the MRI Peripheral Joints and Entheses Inflammation Index. | Week 16 |
| Copenhagen |
| 2600 |
| Denmark |
| Herlev Hospital, Dep. of Radiology | Copenhagen | 2730 | Denmark |
| Gentofte Hospital, Dep. of Rheumatology | Copenhagen | 2900 | Denmark |
| Nordsjællands Hospital Hillerød, Dep. of Rheumatology | Hillerød | 3400 | Denmark |
| Køge Hospital, Dep. of Rheumatology | Køge | 4600 | Denmark |
| Derived |
| 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. |
| 31673422 | Derived | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fulfilment of the radiographic part of the modified New York criteria | Each sacroiliac joint is assigned a score of 0 to 4 based on the appearance on a radiograph, grade 0 is normal, grade 1 is suspicious changes, grade 2 is minimum abnormality, grade 3 is unequivocal abnormality and grade 4 is severe abnormality. A patient fulfils the radiographic part of the modified New York criteria if there is sacroiliitis of at least grade 2 bilaterally or sacroiliitis grade 3 or 4 unilaterally. Reference: Arthritis Rheum 1984;27:361-8. | Count of Participants | Participants |
|
| Body mass index | Median | Inter-Quartile Range | kg/m2 |
|
| Symptom duration | Median | Inter-Quartile Range | years |
|
| Positive for HLA-B27 | Count of Participants | Participants |
|
| hsCRP | C-reactive protein. The assay had a lower limit of detection of 0.3 mg/L. | Median | Inter-Quartile Range | mg/L |
|
| Ankylosing Spondylitis Disease Activity Score (ASDAS) | ASDAS is a composite index to assess disease activity in axSpA. ASDAS parameters: 1) Total back pain 2) Patient global 3) Peripheral pain/swelling 4) Duration of morning stiffness 5) CRP in mg/L: ASDAS calculation: 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(max(CRP,2)+1). CRP is in milligram/liter (mg/L), the range of other variables is from 0 to 10. Data from five variables combine to yield a score (minimum 0.636 to no defined upper limit), higher scores indicate higher disease activity. | Median | Inter-Quartile Range | units on a scale |
|
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | BASDAI is a measure of disease activity which was calculated based on 6 separate questionnaire items that were answered by the patients using visual analogue scale scales with range 0-10. A weighted average was performed, where items 5 and 6 had a weight of 0.5 whereas items 1, 2, 3 and 4 had a weight of 1. Range is from 0 to 10, with 10 indicating more severe disease activity. | Median | Inter-Quartile Range | units on a scale |
|
| Bath Ankylosing Spondylitis Functional Index (BASFI) | BASFI is a measure of physical function which was calculated based on 10 separate questionnaire items that were answered by the patients using visual analogue scales with range 0-10, an average across 10 items was calculated. The range is 0-10 with 10 indicating that the level of physical functioning is more severely affected. | Median | Inter-Quartile Range | units on a scale |
|
| Bath Ankylosing Spondylitis Metrology Index (BASMI) | 5 components of BASMI were each scored 0, 1 or 2, based on physical examination tests of the range of motion of the vertebral column and hips. The scores were added, and the range was 0-10, where 10 indicates a worse metrology (i.e. more severely affected range of motion of the vertebral column and hips). | Median | Inter-Quartile Range | units on a scale |
|
| Chest expansion | Median | Inter-Quartile Range | cm |
|
| Swollen joint count of 66 joints | Median | Inter-Quartile Range | joints |
|
| Tender joint count of 68 joints | Median | Inter-Quartile Range | joints |
|
| Tender enthesis count | Range is 0-35. The entheses assessed were those that are included in either the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES), the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis index or the Leeds Enthesitis Index (LEI). | Median | Inter-Quartile Range | entheses |
|
| Pain score | Questionnaire filled in by the patient, visual analogue scale with range 0-10, 10 indicates more severe pain. | Median | Inter-Quartile Range | units on a scale |
|
| Patient's global score | Questionnaire filled in by the patient to capture the global disease activity as assessed by the patient; visual analogue scale with range 0-10, 10 indicates worse global score | Median | Inter-Quartile Range | units on a scale |
|
| Physician's global score | Questionnaire filled in by the physician to capture the physician's global assessment of disease activity; visual analogue scale with range 0-10, 10 indicates a worse disease activity. | Median | Inter-Quartile Range | units on a scale |
|
| Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) | The mSASSS is an assessment of structural lesions of the spine using lateral radiographs of the cervical and lumbar spine. The mSASSS is the sum of the lumbar and cervical spine score (range 0 [no change] to 72 [severe change]), derived from scoring the anterior sites of the lumbar spine (T12 to S1) and the cervical spine (C2 to T1) as either 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), 3 (bridging syndesmophyte), and adding all scores together. | Median | Inter-Quartile Range | units on a scale |
|
| Canada-Denmark (CANDEN) Magnetic Resonance Imaging (MRI) Spine Inflammation Index | Semiquantitative score of inflammation of the spine as assessed by MRI. A comprehensive assessment system is applied to different anatomical parts of the spine at 23 spinal levels and all scores are summed; range is 0-614 with higher scores indicating more severe inflammation. Reference: RMD Open 2019;5:e001057. | Median | Inter-Quartile Range | units on a scale |
|
| Canada-Denmark (CANDEN) Magnetic Resonance Imaging (MRI) Spine Fat Metaplasia Score | Semiquantitative score of fat metaplasia of the spine as assessed by MRI. A comprehensive assessment system is applied to different anatomical parts of the spine at 23 spinal levels and all scores are summed; range is 0-510 with higher scores indicating more severe fat metaplasia. Reference: RMD Open 2019;5:e001057. | Median | Inter-Quartile Range | units on a scale |
|
| Canada-Denmark (CANDEN) Magnetic Resonance Imaging (MRI) Spine Erosion Score | Semiquantitative score of erosion of the spine as assessed by MRI. A comprehensive assessment system is applied to different anatomical parts of the spine at 23 spinal levels and all scores are summed; range is 0-208 with higher scores indicating more severe erosion. Reference: RMD Open 2019;5:e001057. | Median | Inter-Quartile Range | units on a scale |
|
| Canada-Denmark (CANDEN) Magnetic Resonance Imaging (MRI) Spine New Bone Formation Score | Semiquantitative score of new bone formation of the spine as assessed by MRI. A comprehensive assessment system is applied to different anatomical parts of the spine at 23 spinal levels and all scores are summed; range is 0-460 with higher scores indicating more severe new bone formation. Reference: RMD Open 2019;5:e001057. | Median | Inter-Quartile Range | units on a scale |
|
| SPARCC MRI Spine Inflammation Index | Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Spine Inflammation Index. 23 levels of the spine are assessed for the presence, intensity and depth of inflammation at a maximum of 3 slices per level, and scores are summed together. Range is 0-414 with higher scores indicating more severe inflammation of the spine. | Median | Inter-Quartile Range | units on a scale |
|
| SPARCC MRI Sacroiliac Joint Inflammation Index | Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac Joint Inflammation Index as based on an assessment of the presence, depth and intensity of inflammation as assessed on 6 MRI slices, and all scores are summed together; range is 0-72, with higher scores indicating more severe inflammation of the sacroiliac joints. | Median | Inter-Quartile Range | units on a scale |
|
| SPARCC MRI Sacroiliac Joint Structural Score - Fat | Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac Joint Structural Score - Fat is based on an assessment of MRI images of the sacroilliac joints where the presence of fat is assessed on 5 MRI slices; range is 0-40, with higher scores indicating worse fat metaplasia. | Median | Inter-Quartile Range | units on a scale |
|
| SPARCC MRI Sacroiliac Joint Structural Score - Erosion | Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac Joint Structural Score - Erosion is based on an assessment of MRI images of the sacroilliac joints where the presence of erosion is assessed on 5 MRI slices; range is 0-40, with higher scores indicating worse erosion. | Median | Inter-Quartile Range | units on a scale |
|
| SPARCC MRI Sacroiliac Joint Structural Score - Backfill | Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac Joint Structural Score - Backfill is based on an assessment of MRI images of the sacroilliac joints where the presence of backfill is assessed on 5 MRI slices; range is 0-20, with higher scores indicating worse backfill. According to the recently updated terminology by Assessment of Spondyloarthritis International Society MRI Group, backfill is termed "fat metaplasia in an erosion cavity". | Median | Inter-Quartile Range | units on a scale |
|
| SPARCC MRI Sacroiliac Joint Structural Score - Ankylosis | Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac Joint Structural Score - Ankylosis is based on an assessment of MRI images of the sacroilliac joints where the presence of ankylosis is assessed on 5 MRI slices; range is 0-20, with higher scores indicating worse ankylosis. | Median | Inter-Quartile Range | units on a scale |
|
| MRI Peripheral Joints and Entheses Inflammation Index | Magnetic Resonance Imaging (MRI) Peripheral Joints and Entheses Inflammation Index was based on an assessment of MRI images of several image stations: anterior chest wall and shoulder, hands, pelvis, knees, ankles and feet; 74 joints were assessed for synovitis and osteitis, 30 entheses were assessed for soft tissue inflammation and osteitis, and all scores were summed together; range was 0-210, with higher scores indicating worse inflammation of joints and entheses throughout the body as assessed by MRI. | Median | Inter-Quartile Range | units on a scale |
|
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Inflammatory back pain | IBP according to experts: four out of five of the following parameters present: (1) age at onset less than 40 years, (2) insidious onset, (3) improvement with exercise, (4) no improvement with rest, (5) pain at night (with improvement upon getting up). (Reference: Ann Rheum Dis 2009;68:777-83) | Count of Participants | Participants |
|
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Arthritis | Past or present active synovitis diagnosed by a doctor. (Reference: Ann Rheum Dis 2009;68:777-83) | Count of Participants | Participants |
|
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Heel enthesitis | Heel enthesitis: past or present spontaneous pain or tenderness at examination at the site of the insertion of the Achilles tendon or plantar fascia at the calcaneus. (Reference: Ann Rheum Dis 2009;68:777-83) | Count of Participants | Participants |
|
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Uveitis | Past or present uveitis anterior, confirmed by an ophthalmologist. (Reference: Ann Rheum Dis 2009;68:777-83) | Count of Participants | Participants |
|
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Dactylitis | Past or present dactylitis diagnosed by a doctor. (Reference: Ann Rheum Dis 2009;68:777-83) | Count of Participants | Participants |
|
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Psoriasis | Past or present psoriasis diagnosed by a doctor. (Reference: Ann Rheum Dis 2009;68:777-83) | Count of Participants | Participants |
|
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Inflammatory bowel disease | Past or present Crohn disease or ulcerative colitis diagnosed by a doctor. (Reference: Ann Rheum Dis 2009;68:777-83) | Count of Participants | Participants |
|
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Good response to NSAIDs | At 24-48 h after a full dose of NSAID the back pain is not present anymore or much better. (Reference: Ann Rheum Dis 2009;68:777-83) | Count of Participants | Participants |
|
| Assessment of Spondyloarthritis International Society criteria: Family history of spondyloarthritis | Presence in first-degree or second-degree relatives of any of the following: (a) ankylosing spondylitis, (b) psoriasis, (c) uveitis, (d) reactive arthritis, (e) inflammatory bowel disease. (Reference: Ann Rheum Dis 2009;68:777-83) | Count of Participants | Participants |
|
| Assessment of Spondyloarthritis International Society (ASAS) criteria: Elevated C-reactive protein | CRP above upper normal limit in the presence of back pain, after exclusion of other causes for elevated CRP concentration. (Reference: Ann Rheum Dis 2009;68:777-83) | Count of Participants | Participants |
|
| csDMARDs at baseline | Conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) were allowed, but the dose could not be changed 4 weeks prior to baseline. | Count of Participants | 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. | Posted | Count of Participants | Participants | Week 16 |
|
|
|
| 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. | Posted | Count of Participants | Participants | Week 52 |
|
|
|
| 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. | Posted | Count of Participants | Participants | Week 16 |
|
|
|
| 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. | Posted | Count of Participants | Participants | Week 52 |
|
|
|
| Secondary | MRI Spine Remission | Maximum 1 disco-vertebral unit with inflammation present. | Posted | Count of Participants | Participants | Week 16 |
|
|
|
| Secondary | MRI-SPINE-50 | At least 50% reduction in Canada-Denmark (CANDEN) MRI spine inflammation score. | Posted | Count of Participants | Participants | Week 16 |
|
|
|
| Other Pre-specified | MRI-SIJ-50 | At least 50% decrease in Spondyloarthritis Research Consortium of Canada (SPARCC) MRI sacroiliac joint inflammation index | Posted | Count of Participants | Participants | Week 16 |
|
|
|
| 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'). | Posted | Count of Participants | Participants | Week 16 |
|
|
|
| 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. | Posted | Count of Participants | Participants | Week 16 |
|
|
|
| Other Pre-specified | MRI Peripheral Joints and Entheses Inflammation Remission | A score of maximally 2 of the MRI Peripheral Joints and Entheses Inflammation Index. | Posted | Count of Participants | Participants | Week 16 |
|
|
|
| 53 |
| 0 |
| 53 |
| 20 |
| 53 |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |