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The purpose of this study was to assess the proportion of AS patients achieving treatment response to adalimumab therapy.
This post-marketing observational study (PMOS) was performed in a multi-country, multi-center, single-arm format. Data were collected prospectively and retrospectively. Adult patients with diagnosis of AS who were assigned for treatment with adalimumab (Humira®) were eligible for participation. Each patient included in this study was to be observed during his/her adalimumab treatment for a maximum of 12 month period. During this period four follow-up visits were planned for observation of the patient and documentation of data. Ideally, these visits should have been performed approximately 3 (V1), 6 (V2), 9 (V3) and 12 (V4) months after the baseline visit (V0).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Ankylosing Spondylitis (AS) | Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12 | The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline as observed. | Month 0 (baseline) and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving BASDAI 50 | The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline. | Month 3, Month 6 and Month 9 |
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Inclusion Criteria:
Exclusion Criteria:
- Had contraindications for the treatment with adalimumab
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Study population consisted of participants with ankylosing spondylitis (AS) who were treated with adalimumab as per locally approved label and prescription guidelines. The decision to be treated with adalimumab had to be independent from study inclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Liliana Iosub | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 452 participants were enrolled: 450 were in the main analysis set (MAS) population; 2 were excluded from MAS, as adalimumab treatment was not documented within this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Ankylosing Spondylitis | Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline | The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units. | Month 3, Month 6, Month 9 and Month 12 |
| Mean Change in the Number of Hospital Inpatient Days | Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy. | 12 months prior to month 0 (baseline) and 12 months prior to month 12 |
| Mean Change in the Number of Hospitalizations | Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy. | 12 months prior to month 0 (baseline) and 12 months prior to month 12 |
| Mean Change in the Number of Sick Leave Days | Difference in the number of sick leave days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only) | 12 months prior to month 0 (baseline) and 12 months prior to month 12 |
| Mean Change in the Number of Sick Leaves | Difference in the number of sick leaves during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only). | 12 months prior to month 0 (baseline) and 12 months prior to month 12 |
| Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider | Difference in the number of outpatient visits to each kind of health care provider which includes general practitioner, rheumatologist, other specialists (ophthalmologist, gastroenterologist, dermatologist, physiatrist), physiotherapist and rheumatology nurse, during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy. | 12 months prior to month 0 (baseline) and 12 months prior to month 12 |
| Mean Change From Baseline in BASDAI Score | The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). | Month 3, Month 6, Month 9, Month 12 and Month 12 Last Observation Carried Forward (LOCF) |
| Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score | The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units. | Month 3, Month 6, Month 9 and Month 12 |
| Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | The BASFI is a numeric rating scale that uses self-reported patient evaluations to measure physical function impairment caused by AS. It is a ten questions, each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment). The mean of the ten questions was the total BASFI score. A higher score indicates more severe impairment of functioning. | Month 3, Month 6, Month 9 and Month 12 |
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Baseline analyses accounts for main analysis set (MAS) population (all participants who received at least 1 dose of study drug).
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Ankylosing Spondylitis | Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age (continuous) measure analysis accounts for main analysis set (MAS) population (all participants who received at least 1 dose of study drug) with evaluable data. | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| 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 | Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12 | The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline as observed. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Number | percentage of participants | Month 0 (baseline) and Month 12 |
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| Secondary | Percentage of Participants Achieving BASDAI 50 | The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Number | percentage of participants | Month 3, Month 6 and Month 9 |
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| Secondary | Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline | The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Number | percentage of participants | Month 3, Month 6, Month 9 and Month 12 |
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| Secondary | Mean Change in the Number of Hospital Inpatient Days | Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | Days | 12 months prior to month 0 (baseline) and 12 months prior to month 12 |
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| Secondary | Mean Change in the Number of Hospitalizations | Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | Number of admissions to hospital | 12 months prior to month 0 (baseline) and 12 months prior to month 12 |
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| Secondary | Mean Change in the Number of Sick Leave Days | Difference in the number of sick leave days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only) | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | Days | 12 months prior to month 0 (baseline) and 12 months prior to month 12 |
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| Secondary | Mean Change in the Number of Sick Leaves | Difference in the number of sick leaves during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only). | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | Number of sick leaves | 12 months prior to month 0 (baseline) and 12 months prior to month 12 |
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| Secondary | Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider | Difference in the number of outpatient visits to each kind of health care provider which includes general practitioner, rheumatologist, other specialists (ophthalmologist, gastroenterologist, dermatologist, physiatrist), physiotherapist and rheumatology nurse, during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | Number of visits | 12 months prior to month 0 (baseline) and 12 months prior to month 12 |
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| Secondary | Mean Change From Baseline in BASDAI Score | The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 3, Month 6, Month 9, Month 12 and Month 12 Last Observation Carried Forward (LOCF) |
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| Secondary | Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score | The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 3, Month 6, Month 9 and Month 12 |
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| Secondary | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score | The BASFI is a numeric rating scale that uses self-reported patient evaluations to measure physical function impairment caused by AS. It is a ten questions, each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment). The mean of the ten questions was the total BASFI score. A higher score indicates more severe impairment of functioning. | Analysis included all participants who received at least one dose of adalimumab with evaluable data. | Posted | Mean | Standard Deviation | units on a scale | Month 3, Month 6, Month 9 and Month 12 |
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Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
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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 | Participants With Ankylosing Spondylitis | Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice. | 19 | 450 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| LYMPHOCYTOSIS | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA 18.1 | Non-systematic Assessment |
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| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
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| ADMINISTRATION SITE RASH | General disorders | MedDRA 18.1 | Non-systematic Assessment |
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| DRUG INEFFECTIVE | General disorders | MedDRA 18.1 | Non-systematic Assessment |
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| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| CYSTITIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| GINGIVITIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| PNEUMONIA PSEUDOMONAL | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| TUBERCULOSIS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| TUBERCULOUS PLEURISY | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
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| ANKYLOSING SPONDYLITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
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| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
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| HYPERTONIA | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
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| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
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| RENAL COLIC | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
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| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
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| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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