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Rationale. Coxitis in AS is inflammation of hip(s) affecting significant number of patients. It is associated with worse function and more expressed axial disease requiring hip replacement at end-stage. Number of studies dedicated to coxitis treated with TNF alpha inhibitors is very limited.
Primary objective. To evaluate change of functional impairment in AS patients with coxitis from baseline to 12 months of therapy with golimumab by BASFI in daily clinical practice
Study design. This study is a non-interventional prospective observational cohort study conducted in multiple centers across Russia.
Study population. Patients with ankylosing spondylitis (according to the modified New York criteria) with coxitis newly prescribed golimumab during the course of usual clinical care will be enrolled and followed prospectively for 24 months with data collection at the approximate time points: baseline (pre-treatment) and consequent every 6 months. Patients will receive golimumab as prescribed in regular clinical practice.
Statistical Methods. Quantitative variables will be tested for normal distribution using the Shapiro-Wilk test. The hypothesis of equality of variances will be tested using Levene's test. Quantitative variables matching a normal distribution will be described in terms of the mean ± standard deviation, and values outside of the normal distribution as medians, 25% and 75% quartiles. Qualitative variables will be presented in the form of percentages of the absolute value N.
Sample Size and Power Calculations. Sample size calculation is based on data from GO-RAISE registration study in which golimumab was evaluated in patients with AS. The baseline BASFI was 5.0 which changed by mean (± SD, standard deviation) -2.5 (± 2.12) at week 52 (approximately 12 months). The analysis of the data shows that the minimum necessary sample size should be 18 patients to show a statistically significant change of BASFI from baseline to 12 months. On this basis and considering that the dropout rate over the two years is expected to be 30%, we decided that the necessary number of patients to be included into protocol should be 39 individuals. It is expected that around 27 patients will be included in the patient set completing the study. Power of the study is 90% with formula evaluation P = 1-β where P is power and β is type 2 error = 10%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golimumab injection | Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab Injection | Drug | Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| BASFI (Bath Ankylosing Spodylitis Functionality Index) at 12 Months of Follow-up | The BASFI is a self-assessment instrument for defining functional ability in patients with AS. Contains 10 items: 8 items concerning activities referring to the functional anatomy of the patients (bending, reaching, changing position, standing, turning, and climbing steps) and 2 items assessing the patients' ability to cope with everyday life. Consists of Numeric response scale (0-10) from "easy" to "impossible." The mean of the 10 individual scales (scores) gives the BASFI score - a value between 0 and 10 with 0 reflecting no functional impairments and 10 reflecting maximal impairment. | From baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| BASFI (Bath Ankylosing Spodylitis Functionality Index) at 24 Months of Follow-up | The BASFI is a self-assessment instrument for defining functional ability in patients with AS. Contains 10 items: 8 items concerning activities referring to the functional anatomy of the patients (bending, reaching, changing position, standing, turning, and climbing steps) and 2 items assessing the patients' ability to cope with everyday life. Consists of Numeric response scale (0-10) from "easy" to "impossible." The mean of the 10 individual scales (scores) gives the BASFI score - a value between 0 and 10 with 0 reflecting no functional impairments and 10 reflecting maximal impairment. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Without MRI Inflammatory Lesions in the Right Hip at 6 Months of Follow-up | Percentage of participants without MRI Inflammatory Lesions in the Right Hip at 6 months of follow-up based on result available and suitable for paired analysis. There were no formal scores for MRI of hips at time of study initiation. Information on hips MRI (STIR (short tau inversion recovery) sequence and fat-saturated contrast-enhanced T1-weighted sequence) were collected based on availability: No lesions suggesting inflammation; Subchondral bone marrow edema (expressed as Yes or No); Joint effusion (expressed as Yes or No); Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No); Fatty degeneration (expressed as Yes or No). |
Inclusion Criteria:
Exclusion Criteria:
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Patients with ankylosing spondylitis and coxitis followed in normal practice, in whom golimumab has been newly prescribed.
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| Name | Affiliation | Role |
|---|---|---|
| Ekaterina Lukyanova, MD | MSD Pharmaceuticals LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KhMAO Regional Clinical Hospital | Khanty-Mansiysk | Russia | ||||
| Moscow Clinical Scientific Center |
At least 18 patients to be recruited and followed-up for 12 months for preliminary statistical analysis based on the primary end-point (change of BASFI in 12 months after baseline).
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| ID | Title | Description |
|---|---|---|
| FG000 | Golimumab Injection | Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 12 Months of Follow-up: Interim Analysis |
| |||||||||||||
| 24 Weeks of Follow-up: Final Analysis |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Golimumab Injection | Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | BASFI (Bath Ankylosing Spodylitis Functionality Index) at 12 Months of Follow-up | The BASFI is a self-assessment instrument for defining functional ability in patients with AS. Contains 10 items: 8 items concerning activities referring to the functional anatomy of the patients (bending, reaching, changing position, standing, turning, and climbing steps) and 2 items assessing the patients' ability to cope with everyday life. Consists of Numeric response scale (0-10) from "easy" to "impossible." The mean of the 10 individual scales (scores) gives the BASFI score - a value between 0 and 10 with 0 reflecting no functional impairments and 10 reflecting maximal impairment. | Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30) | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 12 months |
|
Adverse events were collected from start of treatment (baseline) up to 2 years of follow-up during treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Golimumab Injection | Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label. Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcohol intoxication | Injury, poisoning and procedural complications | Non-systematic Assessment | Fatal serious adverse event |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute respiratory viral infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | The most common AE reported |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Achikyan | MSD Pharmaceuticals LLC | +74959167100 | vladimir.achikyan@merck.com |
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| 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 | Jan 15, 2018 | Jul 27, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| C529000 | golimumab |
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| From baseline to 24 months |
| BASMI (Bath Ankylosing Spodylitis Mobility Index) at 12 Months of Follow-up | The Bath Ankylosing Spondylitis Metrology Index (BASMI) is used to assess mobility of spine and hip joints. The BASMI score is a sum of the 5 measures: cervical rotation (>85.0° to ≤8.5°), tragus to wall distance (<10 cm to ≥38 cm), lumbar flexion (>7.0 cm to ≤0.7 cm), lumbar side flexion (>20.0 cm to <1.2 cm), and intermalleolar distance (≥120 cm to <30 cm). Each item is scored from 0 to 10 based on defined cut points. The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation. | From baseline to 12 months |
| BASMI (Bath Ankylosing Spodylitis Mobility Index) at 24 Months of Follow-up | The Bath Ankylosing Spondylitis Metrology Index (BASMI) is used to assess mobility of spine and hip joints. The BASMI score is a sum of the 5 measures: cervical rotation (>85.0° to ≤8.5°), tragus to wall distance (<10 cm to ≥38 cm), lumbar flexion (>7.0 cm to ≤0.7 cm), lumbar side flexion (>20.0 cm to <1.2 cm), and intermalleolar distance (≥120 cm to <30 cm). Each item is scored from 0 to 10 based on defined cut points. The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation. | From baseline to 24 months |
| ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 12 Months of Follow-up | The ASDAS-CRP is to measure disease activity based on a composite score. The score includes patient-reported assessments of back pain, duration of morning stiffness, peripheral joint pain and/or swelling, general well-being, and a serologic marker of inflammation C-reactive protein (CRP). Patient response items and a serologic measure of inflammation are mathematically combined to give the ASDAS-CRP. Score ranges from zero (reflecting no disease activity) with the upper end of the scale being determined by the level of the CRP. | From baseline to 12 months |
| ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 24 Months of Follow-up | The ASDAS-CRP is to measure disease activity based on a composite score. The score includes patient-reported assessments of back pain, duration of morning stiffness, peripheral joint pain and/or swelling, general well-being, and a serologic marker of inflammation C-reactive protein (CRP). Patient response items and a serologic measure of inflammation are mathematically combined to give the ASDAS-CRP. Score ranges from zero (reflecting no disease activity) with the upper end of the scale being determined by the level of the CRP. | From baseline to 24 months |
| BASDAI (Bath AS Disease Activity Index) at 12 Months of Follow-up | The BASDAI is an instrument to measure disease activity in AS based on a composite score.The index includes patient-reported levels of back pain, fatigue, peripheral joint pain and swelling, localized tenderness, and the duration and severity of morning stiffness. It contains 6 items with numeric response scales (0-10) or visual analog scales (VAS, 0-10 cm) anchored by adjectival descriptors "none" and "very severe." Duration of morning stiffness is anchored by a time scale (0-2 or more hours). | From baseline to 12 months |
| BASDAI (Bath AS Disease Activity Index) at 24 Months of Follow-up | The BASDAI is an instrument to measure disease activity in AS based on a composite score.The index includes patient-reported levels of back pain, fatigue, peripheral joint pain and swelling, localized tenderness, and the duration and severity of morning stiffness. It contains 6 items with numeric response scales (0-10) or visual analog scales (VAS, 0-10 cm) anchored by adjectival descriptors "none" and "very severe." Duration of morning stiffness is anchored by a time scale (0-2 or more hours). | From baseline to 24 months |
| BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 12 Months of Follow-up | The BASRI-hip is a score of structural impairment of hip on X-ray images: 0 - no change; 1 - suspicious: focal joint space narrowing; 2 - mild: circumferential joint space narrowing >2mm; 3 - moderate: circumferential joint space narrowing ≤ 2mm or bone-on-bone apposition of <2 cm; 4 - severe: bone deformity or bone-on-bone apposition of ≥2 cm. | From baseline to 12 months |
| BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 24 Months of Follow-up | The BASRI-hip is a score of structural impairment of hip on X-ray images: 0 - no change; 1 - suspicious: focal joint space narrowing; 2 - mild: circumferential joint space narrowing >2mm; 3 - moderate: circumferential joint space narrowing ≤ 2mm or bone-on-bone apposition of <2 cm; 4 - severe: bone deformity or bone-on-bone apposition of ≥2 cm. | From baseline to 24 months |
| 6 months from the baseline |
| Percentage of Participants Without MRI Inflammatory Lesions in the Left Hip at 6 Months of Follow-up | Percentage of participants without MRI Inflammatory Lesions in the Left Hip at 6 months of follow-up based on result available and suitable for paired analysis. There were no formal scores for MRI of hips at time of study initiation. Information on hips MRI (STIR (short tau inversion recovery) sequence and fat-saturated contrast-enhanced T1-weighted sequence) were collected based on availability: No lesions suggesting inflammation; Subchondral bone marrow edema (expressed as Yes or No); Joint effusion (expressed as Yes or No); Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No); Fatty degeneration (expressed as Yes or No). | 6 months from the baseline |
| Percentage of Participants Without MRI Inflammatory Lesions in the Right Hip at 12 Months of Follow-up | Percentage of participants without MRI Inflammatory Lesions in the Right Hip at 12 months of follow-up based on result available and suitable for paired analysis. There were no formal scores for MRI of hips at time of study initiation. Information on hips MRI (STIR (short tau inversion recovery) sequence and fat-saturated contrast-enhanced T1-weighted sequence) were collected based on availability: No lesions suggesting inflammation; Subchondral bone marrow edema (expressed as Yes or No); Joint effusion (expressed as Yes or No); Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No); Fatty degeneration (expressed as Yes or No). | 12 months from the baseline |
| Percentage of Participants Without MRI Inflammatory Lesions in the Left Hip at 12 Months of Follow-up | Percentage of participants without MRI Inflammatory Lesions in the Left Hip at 12 months of follow-up based on result available and suitable for paired analysis. There were no formal scores for MRI of hips at time of study initiation. Information on hips MRI (STIR (short tau inversion recovery) sequence and fat-saturated contrast-enhanced T1-weighted sequence) were collected based on availability: No lesions suggesting inflammation; Subchondral bone marrow edema (expressed as Yes or No); Joint effusion (expressed as Yes or No); Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No); Fatty degeneration (expressed as Yes or No). | 12 months from the baseline |
| Percentage of Participants Without US Inflammatory Lesions in the Right Hip at 6 Months of Follow-up | Percentage of participants without US Inflammatory Lesions in the Right Hip at 6 months of follow-up based on result available and suitable for paired analysis. There were no standardized US scores available for hips at the time of study initiation. Information on hip(s) US was collected for patients based on availability in the patient charts: Joint effusion (expressed as Yes or No); Distance between lower margin of femoral neck and lower part of joint capsule expressed in millimeters; Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No). | 6 months from the baseline |
| Percentage of Participants Without US Inflammatory Lesions in the Left Hip at 6 Months of Follow-up | Percentage of participants without US Inflammatory Lesions in the Left Hip at 6 months of follow-up based on result available and suitable for paired analysis. There were no standardized US scores available for hips at the time of study initiation. Information on hip(s) US was collected for patients based on availability in the patient charts: Joint effusion (expressed as Yes or No); Distance between lower margin of femoral neck and lower part of joint capsule expressed in millimeters; Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No). | 6 months from the baseline |
| Percentage of Participants Without US Inflammatory Lesions in the Right Hip at 12 Months of Follow-up | Percentage of participants without US Inflammatory Lesions in the Right Hip at 12 months of follow-up based on result available and suitable for paired analysis. There were no standardized US scores available for hips at the time of study initiation. Information on hip(s) US was collected for patients based on availability in the patient charts: Joint effusion (expressed as Yes or No); Distance between lower margin of femoral neck and lower part of joint capsule expressed in millimeters; Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No). | 12 months from the baseline |
| Percentage of Participants Without US Inflammatory Lesions in the Left Hip at 12 Months of Follow-up | Percentage of participants without US Inflammatory Lesions in the Left Hip at 12 months of follow-up based on result available and suitable for paired analysis. There were no standardized US scores available for hips at the time of study initiation. Information on hip(s) US was collected for patients based on availability in the patient charts: Joint effusion (expressed as Yes or No); Distance between lower margin of femoral neck and lower part of joint capsule expressed in millimeters; Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No). | 12 months from the baseline |
| Moscow |
| Russia |
| Pirogov National Medical Surgical Center | Moscow | Russia |
| Rheumatology Research Institute | Moscow | Russia |
| Regional Clinical Hospital #2 | Rostov-on-Don | Russia |
| City Clinical Hospital | Yakutsk | Russia |
| 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 | Count of Participants | Participants |
|
| Coxitis symptoms duration | Median | Full Range | months |
|
| Bath Ankylosing Spondylitis Functionality Index (BASFI) | The BASFI is a self-assessment instrument for defining functional ability in patients with AS. Contains 10 items: 8 items concerning activities referring to the functional anatomy of the patients (bending, reaching, changing position, standing, turning, and climbing steps) and 2 items assessing the patients' ability to cope with everyday life. Consists of Numeric response scale (0-10) from "easy" to "impossible." The mean of the 10 individual scales (scores) gives the BASFI score - a value between 0 and 10 with 0 reflecting no functional impairments and 10 reflecting maximal impairment. | Results of clinical effect assessment population are presented (n=30) | Median | Inter-Quartile Range | units on a scale |
|
| Bath Ankylosing Spondylitis Metrological Index (BASMI) | The Bath Ankylosing Spondylitis Metrology Index (BASMI) is used to assess mobility of spine and hip joints. The BASMI score is a sum of the 5 measures: cervical rotation (>85.0° to ≤8.5°), tragus to wall distance (<10 cm to ≥38 cm), lumbar flexion (>7.0 cm to ≤0.7 cm), lumbar side flexion (>20.0 cm to <1.2 cm), and intermalleolar distance (≥120 cm to <30 cm). Each item is scored from 0 to 10 based on defined cut points. The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation. | Results of clinical effect assessment population are presented (n=30) | Median | Inter-Quartile Range | units on a scale |
|
| Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) | The ASDAS-CRP is to measure disease activity based on a composite score. The score includes patient-reported assessments of back pain, duration of morning stiffness, peripheral joint pain and/or swelling, general well-being, and a serologic marker of inflammation C-reactive protein (CRP). Patient response items and a serologic measure of inflammation are mathematically combined to give the ASDAS-CRP. Score ranges from zero (reflecting no disease activity) with the upper end of the scale being determined by the level of the CRP. | Results of clinical effect assessment population are presented (n=30) | Median | Inter-Quartile Range | units on a scale |
|
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | The BASDAI is an instrument to measure disease activity in AS based on a composite score.The index includes patient-reported levels of back pain, fatigue, peripheral joint pain and swelling, localized tenderness, and the duration and severity of morning stiffness. It contains 6 items with numeric response scales (0-10) or visual analog scales (VAS, 0-10 cm) anchored by adjectival descriptors "none" and "very severe." Duration of morning stiffness is anchored by a time scale (0-2 or more hours). | Results of clinical effect assessment population are presented (n=30) | Median | Inter-Quartile Range | units on a scale |
|
| Bath Ankylosing Spondylitis Radiographic Score (BASRI) Right Hip | The BASRI-hip is a score of structural impairment of hip on X-ray images: 0 - no change; 1 - suspicious: focal joint space narrowing; 2 - mild: circumferential joint space narrowing >2mm; 3 - moderate: circumferential joint space narrowing ≤ 2mm or bone-on-bone apposition of <2 cm; 4 - severe: bone deformity or bone-on-bone apposition of ≥2 cm. | Results of clinical effect assessment population are presented (n=30) | Median | Inter-Quartile Range | units on a scale |
|
| Bath Ankylosing Spondylitis Radiographic Score (BASRI) Left Hip | The BASRI-hip is a score of structural impairment of hip on X-ray images: 0 - no change; 1 - suspicious: focal joint space narrowing; 2 - mild: circumferential joint space narrowing >2mm; 3 - moderate: circumferential joint space narrowing ≤ 2mm or bone-on-bone apposition of <2 cm; 4 - severe: bone deformity or bone-on-bone apposition of ≥2 cm. | Results of clinical effect assessment population are presented (n=30) | Median | Inter-Quartile Range | units on a scale |
|
| Percentage of participants without MRI Inflammatory Lesions | There were no formal scores for MRI of hips at time of study initiation. Information on hips MRI (STIR (short tau inversion recovery) sequence and fat-saturated contrast-enhanced T1-weighted sequence) were collected based on availability: No lesions suggesting inflammation; Subchondral bone marrow edema (expressed as Yes or No); Joint effusion (expressed as Yes or No); Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No); Fatty degeneration (expressed as Yes or No). | Data are based on available MRI results suitable for paired analysis. | Count of Participants | Participants |
|
| Percentage of patients without Hips US Inflammatory Lesions | There were no standardized US scores available for hips at the time of study initiation. Information on hip(s) US was collected for patients based on availability in the patient charts: Joint effusion (expressed as Yes or No); Distance between lower margin of femoral neck and lower part of joint capsule expressed in millimeters; Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No). | Data are based on available US results suitable for paired analysis. | Count of Participants | Participants |
|
Patients with ankylosing spondylitis and coxitis being treated with Simponi (golimumab) according to local clinical practice and label.
Golimumab Injection: Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
|
|
| Secondary | BASFI (Bath Ankylosing Spodylitis Functionality Index) at 24 Months of Follow-up | The BASFI is a self-assessment instrument for defining functional ability in patients with AS. Contains 10 items: 8 items concerning activities referring to the functional anatomy of the patients (bending, reaching, changing position, standing, turning, and climbing steps) and 2 items assessing the patients' ability to cope with everyday life. Consists of Numeric response scale (0-10) from "easy" to "impossible." The mean of the 10 individual scales (scores) gives the BASFI score - a value between 0 and 10 with 0 reflecting no functional impairments and 10 reflecting maximal impairment. | Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30) | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 24 months |
|
|
|
| Secondary | BASMI (Bath Ankylosing Spodylitis Mobility Index) at 12 Months of Follow-up | The Bath Ankylosing Spondylitis Metrology Index (BASMI) is used to assess mobility of spine and hip joints. The BASMI score is a sum of the 5 measures: cervical rotation (>85.0° to ≤8.5°), tragus to wall distance (<10 cm to ≥38 cm), lumbar flexion (>7.0 cm to ≤0.7 cm), lumbar side flexion (>20.0 cm to <1.2 cm), and intermalleolar distance (≥120 cm to <30 cm). Each item is scored from 0 to 10 based on defined cut points. The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation. | Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30) | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 12 months |
|
|
|
| Secondary | BASMI (Bath Ankylosing Spodylitis Mobility Index) at 24 Months of Follow-up | The Bath Ankylosing Spondylitis Metrology Index (BASMI) is used to assess mobility of spine and hip joints. The BASMI score is a sum of the 5 measures: cervical rotation (>85.0° to ≤8.5°), tragus to wall distance (<10 cm to ≥38 cm), lumbar flexion (>7.0 cm to ≤0.7 cm), lumbar side flexion (>20.0 cm to <1.2 cm), and intermalleolar distance (≥120 cm to <30 cm). Each item is scored from 0 to 10 based on defined cut points. The scale of the BASMI ranges from 0 to 10, where 0 is no mobility limitation and 10 is a very severe limitation. | Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30) | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 24 months |
|
|
|
| Secondary | ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 12 Months of Follow-up | The ASDAS-CRP is to measure disease activity based on a composite score. The score includes patient-reported assessments of back pain, duration of morning stiffness, peripheral joint pain and/or swelling, general well-being, and a serologic marker of inflammation C-reactive protein (CRP). Patient response items and a serologic measure of inflammation are mathematically combined to give the ASDAS-CRP. Score ranges from zero (reflecting no disease activity) with the upper end of the scale being determined by the level of the CRP. | Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30) | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 12 months |
|
|
|
| Secondary | ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score) at 24 Months of Follow-up | The ASDAS-CRP is to measure disease activity based on a composite score. The score includes patient-reported assessments of back pain, duration of morning stiffness, peripheral joint pain and/or swelling, general well-being, and a serologic marker of inflammation C-reactive protein (CRP). Patient response items and a serologic measure of inflammation are mathematically combined to give the ASDAS-CRP. Score ranges from zero (reflecting no disease activity) with the upper end of the scale being determined by the level of the CRP. | Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30) | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 24 months |
|
|
|
| Secondary | BASDAI (Bath AS Disease Activity Index) at 12 Months of Follow-up | The BASDAI is an instrument to measure disease activity in AS based on a composite score.The index includes patient-reported levels of back pain, fatigue, peripheral joint pain and swelling, localized tenderness, and the duration and severity of morning stiffness. It contains 6 items with numeric response scales (0-10) or visual analog scales (VAS, 0-10 cm) anchored by adjectival descriptors "none" and "very severe." Duration of morning stiffness is anchored by a time scale (0-2 or more hours). | Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30) | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 12 months |
|
|
|
| Secondary | BASDAI (Bath AS Disease Activity Index) at 24 Months of Follow-up | The BASDAI is an instrument to measure disease activity in AS based on a composite score.The index includes patient-reported levels of back pain, fatigue, peripheral joint pain and swelling, localized tenderness, and the duration and severity of morning stiffness. It contains 6 items with numeric response scales (0-10) or visual analog scales (VAS, 0-10 cm) anchored by adjectival descriptors "none" and "very severe." Duration of morning stiffness is anchored by a time scale (0-2 or more hours). | Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30) | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 24 months |
|
|
|
| Secondary | BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 12 Months of Follow-up | The BASRI-hip is a score of structural impairment of hip on X-ray images: 0 - no change; 1 - suspicious: focal joint space narrowing; 2 - mild: circumferential joint space narrowing >2mm; 3 - moderate: circumferential joint space narrowing ≤ 2mm or bone-on-bone apposition of <2 cm; 4 - severe: bone deformity or bone-on-bone apposition of ≥2 cm. | Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30) | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 12 months |
|
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| Secondary | BASRI-hip (Bath Ankylosing Spondylitis Radiology Index) at 24 Months of Follow-up | The BASRI-hip is a score of structural impairment of hip on X-ray images: 0 - no change; 1 - suspicious: focal joint space narrowing; 2 - mild: circumferential joint space narrowing >2mm; 3 - moderate: circumferential joint space narrowing ≤ 2mm or bone-on-bone apposition of <2 cm; 4 - severe: bone deformity or bone-on-bone apposition of ≥2 cm. | Patients completed 12 months follow-up from the baseline. Results of clinical effect assessment population are presented (n=30) | Posted | Median | Inter-Quartile Range | units on a scale | From baseline to 24 months |
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| Other Pre-specified | Percentage of Participants Without MRI Inflammatory Lesions in the Right Hip at 6 Months of Follow-up | Percentage of participants without MRI Inflammatory Lesions in the Right Hip at 6 months of follow-up based on result available and suitable for paired analysis. There were no formal scores for MRI of hips at time of study initiation. Information on hips MRI (STIR (short tau inversion recovery) sequence and fat-saturated contrast-enhanced T1-weighted sequence) were collected based on availability: No lesions suggesting inflammation; Subchondral bone marrow edema (expressed as Yes or No); Joint effusion (expressed as Yes or No); Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No); Fatty degeneration (expressed as Yes or No). | Posted | Count of Participants | Participants | 6 months from the baseline |
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| Other Pre-specified | Percentage of Participants Without MRI Inflammatory Lesions in the Left Hip at 6 Months of Follow-up | Percentage of participants without MRI Inflammatory Lesions in the Left Hip at 6 months of follow-up based on result available and suitable for paired analysis. There were no formal scores for MRI of hips at time of study initiation. Information on hips MRI (STIR (short tau inversion recovery) sequence and fat-saturated contrast-enhanced T1-weighted sequence) were collected based on availability: No lesions suggesting inflammation; Subchondral bone marrow edema (expressed as Yes or No); Joint effusion (expressed as Yes or No); Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No); Fatty degeneration (expressed as Yes or No). | Posted | Count of Participants | Participants | 6 months from the baseline |
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| Other Pre-specified | Percentage of Participants Without MRI Inflammatory Lesions in the Right Hip at 12 Months of Follow-up | Percentage of participants without MRI Inflammatory Lesions in the Right Hip at 12 months of follow-up based on result available and suitable for paired analysis. There were no formal scores for MRI of hips at time of study initiation. Information on hips MRI (STIR (short tau inversion recovery) sequence and fat-saturated contrast-enhanced T1-weighted sequence) were collected based on availability: No lesions suggesting inflammation; Subchondral bone marrow edema (expressed as Yes or No); Joint effusion (expressed as Yes or No); Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No); Fatty degeneration (expressed as Yes or No). | Posted | Count of Participants | Participants | 12 months from the baseline |
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| Other Pre-specified | Percentage of Participants Without MRI Inflammatory Lesions in the Left Hip at 12 Months of Follow-up | Percentage of participants without MRI Inflammatory Lesions in the Left Hip at 12 months of follow-up based on result available and suitable for paired analysis. There were no formal scores for MRI of hips at time of study initiation. Information on hips MRI (STIR (short tau inversion recovery) sequence and fat-saturated contrast-enhanced T1-weighted sequence) were collected based on availability: No lesions suggesting inflammation; Subchondral bone marrow edema (expressed as Yes or No); Joint effusion (expressed as Yes or No); Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No); Fatty degeneration (expressed as Yes or No). | Posted | Count of Participants | Participants | 12 months from the baseline |
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| Other Pre-specified | Percentage of Participants Without US Inflammatory Lesions in the Right Hip at 6 Months of Follow-up | Percentage of participants without US Inflammatory Lesions in the Right Hip at 6 months of follow-up based on result available and suitable for paired analysis. There were no standardized US scores available for hips at the time of study initiation. Information on hip(s) US was collected for patients based on availability in the patient charts: Joint effusion (expressed as Yes or No); Distance between lower margin of femoral neck and lower part of joint capsule expressed in millimeters; Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No). | Posted | Count of Participants | Participants | 6 months from the baseline |
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| Other Pre-specified | Percentage of Participants Without US Inflammatory Lesions in the Left Hip at 6 Months of Follow-up | Percentage of participants without US Inflammatory Lesions in the Left Hip at 6 months of follow-up based on result available and suitable for paired analysis. There were no standardized US scores available for hips at the time of study initiation. Information on hip(s) US was collected for patients based on availability in the patient charts: Joint effusion (expressed as Yes or No); Distance between lower margin of femoral neck and lower part of joint capsule expressed in millimeters; Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No). | Posted | Count of Participants | Participants | 6 months from the baseline |
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| Other Pre-specified | Percentage of Participants Without US Inflammatory Lesions in the Right Hip at 12 Months of Follow-up | Percentage of participants without US Inflammatory Lesions in the Right Hip at 12 months of follow-up based on result available and suitable for paired analysis. There were no standardized US scores available for hips at the time of study initiation. Information on hip(s) US was collected for patients based on availability in the patient charts: Joint effusion (expressed as Yes or No); Distance between lower margin of femoral neck and lower part of joint capsule expressed in millimeters; Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No). | Posted | Count of Participants | Participants | 12 months from the baseline |
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| Other Pre-specified | Percentage of Participants Without US Inflammatory Lesions in the Left Hip at 12 Months of Follow-up | Percentage of participants without US Inflammatory Lesions in the Left Hip at 12 months of follow-up based on result available and suitable for paired analysis. There were no standardized US scores available for hips at the time of study initiation. Information on hip(s) US was collected for patients based on availability in the patient charts: Joint effusion (expressed as Yes or No); Distance between lower margin of femoral neck and lower part of joint capsule expressed in millimeters; Enthesitis at sites where ligaments and tendons are attached to bone in structures adjacent to the hip joint (expressed as Yes or No). | Posted | Count of Participants | Participants | 12 months from the baseline |
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| 1 |
| 39 |
| 3 |
| 39 |
| 12 |
| 39 |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Ovarian cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Alanine aminotransferase (ALT) level increased | Gastrointestinal disorders | Non-systematic Assessment |
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| Aspartate transaminase (AST) level increased | Gastrointestinal disorders | Non-systematic Assessment |
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| Eye pain | Eye disorders | Non-systematic Assessment |
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| Pain in the breast | Reproductive system and breast disorders | Non-systematic Assessment |
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| Pain in metatarsophalangeal joints | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pain in hip joint | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pain in epigastric region | Gastrointestinal disorders | Non-systematic Assessment |
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| Pain in gluteal region | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Discharges from genital tract | Reproductive system and breast disorders | Non-systematic Assessment |
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| Itching in genital area | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Deflection of nasal septum | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Colpitis | Reproductive system and breast disorders | Non-systematic Assessment |
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| Latent tuberculosis infection | Infections and infestations | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Mycoplasmosis | Infections and infestations | Non-systematic Assessment |
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| Loose stool | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Watery eyes | Eye disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Ureaplasmosis | Infections and infestations | Non-systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | Non-systematic Assessment |
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Not provided
Not provided
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |