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Terminated
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An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis
This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with AS in comparison with patients receiving other TNF blockers. For the RemsimaTM cohort data will be collected for patients who commence treatment with RemsimaTM in accordance with the product label at the time of enrolment. Patients who have been treated with Remicade® prior to enrolment, their dosing schedule will be continued appropriately. This observational study allows drug switching between anti-TNF drugs. If switched to RemsimaTM, data will be collected until the end of study for each patient. If switched to other anti-TNF drugs (infliximab (Remicade®), etanercept, adalimumab and etc.), data will be collected until 1 year from the day of switch or until the end of study for each patient, whichever reaches earlier. For switched patients, their assessment schedule will be re-started from the day of switch. Patients will undergo safety and efficacy assessments in accordance with routine medical practice. The decision to treat with RemsimaTM will be independent of the decision to enroll the patient in this registry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remsima™ | Patients who have received only Remsima were included in this analysis group | ||
| Switch to Remsima I | Patients who switched from Remicade to Remsima were included in this analysis group. | ||
| Switch to Remsima II | Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group | ||
| Remicade | Patients who switched from Remsima to Remicade were included in this analysis group. | ||
| Switch to Remicade I | Patients who switched from Remsima to Remicade were included in this analysis group. | ||
| Switch to Remicade II | Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group. | ||
| Other anti-TNF drugs | Following patients were included in other anti-TNF group.
|
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| Measure | Description | Time Frame |
|---|---|---|
| The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI) |
| Duration of study participation (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| The Number and Percentage of Patients Achieving BASDAI 50 | Efficacy was assessed by the evaluation of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The BASDAI questionnaire consists of 6 component questions about the disease activity. For each question the possible answer from the patient is a whole number from 0 to 10 inclusive where 0 = None and 10 = Very severe. The BASDAI score is generated from the set of 6 questions and calculated using the following formula BASDAI = [Q1+Q2+Q3+Q4+([Q5+Q6]/2)]/5. The number and percentage of patients achieving BASDAI 50 will be displayed. BASDAI 50 is defined as a 50% decrease of the baseline BASDAI score. Percentages will be calculated using the number of patients who perform the assessment at each time point. |
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Inclusion Criteria:
Adult patients
Patients with active AS
Patients who meet the following conditions can be enrolled:
i) The RemsimaTM cohort will include all patients who will start RemsimaTM at the time of enrolment in accordance to the approved product label ii) Patients who have started to be treated with an established anti -TNF such as Infliximab (Remicade®), Etanercept, Adalimumab and etc. within 6 months
Female patients of childbearing potential who agree to use of adequate contraception to prevent pregnancy and continuation of contraceptive use for at least 6 months after their final dose of RemsimaTM.
Patients (or legal guardian, if applicable) who are willing to give informed consent for long term follow-up including access to all medical records
Exclusion Criteria:
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Approximately 1000 male or female patients with confirmed diagnosis of AS.
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| Name | Affiliation | Role |
|---|---|---|
| Klara Sirova | Revmatologie MUDr. Klara Sirova s.r.o. Chelčického 616/12 , 702 00, Czech Republic | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34250583 | Derived | Cheon JH, Nah S, Kang HW, Lim YJ, Lee SH, Lee SJ, Kim SH, Jung NH, Park JE, Lee YJ, Jeon DB, Lee YM, Kim JM, Park SH. Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness. Adv Ther. 2021 Aug;38(8):4366-4387. doi: 10.1007/s12325-021-01834-3. Epub 2021 Jul 12. |
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A total of 350 patients were screened, and 329 patients were enrolled.
Participant flow was summarized by all analysis groups as prespecified in Statistical Analysis Plan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Remsima | Patients who have received only Remsima were included in this analysis group |
| FG001 | Switch to Remsima | Patients who switched from Remicade to Remsima were included in this analysis group. |
| FG002 | Switch to Remsima II | Patients who switched to Remsima from biologic treatment other than Remicade will be included in this analysis group. |
| FG003 | Remicade | Patients who have received only Remicade were included in this analysis group. |
| FG004 | Switch to Remicade | Patients who switched from Remsima to Remicade were included in this analysis group. |
| FG005 | Switch to Remicade II | Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group. |
| FG006 | Other Anti-TNF | Following patients were included in other anti-TNF group.
|
| FG007 | Switch to Other Anti-TNF | Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients data were analyzed; however, there were 0 patients recruited in the "Switch to Remicade II" groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | Remsima | Patients who have received only Remsima were included in this analysis group |
| BG001 | Switch to Remsima I | Patients who switched from Remicade to Remsima were included in this analysis group. |
| 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 | The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI) |
| All patients data were analyzed; however, there were 0 patients recruited in the "Switch to Remicade II" groups. | Posted | Count of Participants | Participants | Duration of study participation (up to 5 years) |
|
Duration of study participation (up to 5 years)
Adverse events were summarized by all analysis groups.
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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 | Remsima | Patients who have received only Remsima were included in this analysis group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deafness neurosensory | Ear and labyrinth disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| JiWoong Lim | Celltrion Inc | 82-32-850-5702 | jiwoong.lim@celltrion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2015 | Aug 23, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2020 | Aug 23, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| Switch to Other Anti-TNF | Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group |
| Month 6 ~ Month 48 (every 6 months ± 6 weeks) |
| Descriptive Statistics for BASFI | The Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaire consists of 10 component questions measuring functionality. Each item was given a rating by the patient which is a whole number from 0 to 10 inclusive where 0 = Easy and 10 = Impossible. The BASFI score is generated from the mean of the scores for the 10 items. The lowest score is 0 and the highest score is 10, with higher scores indicating a higher degree of functional limitation in patients. | Day 0 ~ Month 48 (every 6 months ± 6 weeks) |
| Descriptive Statistics of Physician Global Assessment Score | Physician and Patient Global Assessment of disease status was measured by Visual Analogue Scale (VAS) (0-100 mm) for EU patients and Numerical Rating Scale (NRS) (0-10) for Korea patients where higher scores indicated poorer status. Descriptive statistics for actual value of Global Assessment Score were summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS was transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more disease activity. | Day 0 ~ Month 48 (every 6 months ±6 weeks) |
| Descriptive Statistics of Patient Global Assessment Score | Physician and Patient Global Assessment of disease status was measured by Visual Analogue Scale (VAS) (0-100 mm) for EU patients and Numerical Rating Scale (NRS) (0-10) for Korea patients where higher scores indicated poorer status. Descriptive statistics for actual value of Global Assessment Score were summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS was transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more disease activity. | Day 0 ~ Month 48 (every 6 months ±6 weeks) |
| Descriptive Statistics of Spinal Pain Score | Patient Assessment of Spinal Pain will be measured by VAS (0-100 mm) for EU patients and NRS (0-10) for Korea patients where higher scores indicates more severe pain. Descriptive statistics for actual value of Spinal Pain Score will be summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS will be transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more pain as assessed by the patient. | Day 0 ~ Month 48 (every 6 months ±6 weeks) |
| Disease Progression |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Death |
|
| Study Close |
|
| Except for study close |
|
| BG002 | Switch to Remsima II | Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group |
| BG003 | Remicade | Patients who have received only Remicade were included in this analysis group. |
| BG004 | Switch to Remicade I | Patients who switched from Remsima to Remicade were included in this analysis group. |
| BG005 | Switch to Remicade II | Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group. |
| BG006 | Other Anti-TNF Drugs | Following patients were included in other anti-TNF group.
|
| BG007 | Switch to Other Anti-TNF | Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 | Remsima | Patients who have received only Remsima were included in this analysis group |
| OG001 | Switch to Remsima I | Patients who switched from Remicade to Remsima were included in this analysis group. |
| OG002 | Switch to Remsima II | Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group |
| OG003 | Remicade | Patients who have received only Remicade were included in this analysis group. |
| OG004 | Switch to Remicade I | Patients who switched from Remsima to Remicade were included in this analysis group. |
| OG005 | Switch to Remicade II | Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group |
| OG006 | Other Anti-TNF | Following patients were included in other anti-TNF group.
|
| OG007 | Switch to Other Anti-TNF | Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group. |
|
|
| Secondary | The Number and Percentage of Patients Achieving BASDAI 50 | Efficacy was assessed by the evaluation of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The BASDAI questionnaire consists of 6 component questions about the disease activity. For each question the possible answer from the patient is a whole number from 0 to 10 inclusive where 0 = None and 10 = Very severe. The BASDAI score is generated from the set of 6 questions and calculated using the following formula BASDAI = [Q1+Q2+Q3+Q4+([Q5+Q6]/2)]/5. The number and percentage of patients achieving BASDAI 50 will be displayed. BASDAI 50 is defined as a 50% decrease of the baseline BASDAI score. Percentages will be calculated using the number of patients who perform the assessment at each time point. | Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups. | Posted | Count of Participants | Participants | Month 6 ~ Month 48 (every 6 months ± 6 weeks) |
|
|
|
| Secondary | Descriptive Statistics for BASFI | The Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaire consists of 10 component questions measuring functionality. Each item was given a rating by the patient which is a whole number from 0 to 10 inclusive where 0 = Easy and 10 = Impossible. The BASFI score is generated from the mean of the scores for the 10 items. The lowest score is 0 and the highest score is 10, with higher scores indicating a higher degree of functional limitation in patients. | The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during the analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups. | Posted | Mean | Standard Deviation | score on a scale | Day 0 ~ Month 48 (every 6 months ± 6 weeks) |
|
|
|
| Secondary | Descriptive Statistics of Physician Global Assessment Score | Physician and Patient Global Assessment of disease status was measured by Visual Analogue Scale (VAS) (0-100 mm) for EU patients and Numerical Rating Scale (NRS) (0-10) for Korea patients where higher scores indicated poorer status. Descriptive statistics for actual value of Global Assessment Score were summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS was transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more disease activity. | The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during the analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups. | Posted | Mean | Standard Deviation | score on a scale | Day 0 ~ Month 48 (every 6 months ±6 weeks) |
|
|
|
| Secondary | Descriptive Statistics of Patient Global Assessment Score | Physician and Patient Global Assessment of disease status was measured by Visual Analogue Scale (VAS) (0-100 mm) for EU patients and Numerical Rating Scale (NRS) (0-10) for Korea patients where higher scores indicated poorer status. Descriptive statistics for actual value of Global Assessment Score were summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS was transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more disease activity. | The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during the analysis period. Efficacy analysis was only performed in the Remsima, Switch to Remsima, Remicade and Switch to Remicade analysis groups. | Posted | Mean | Standard Deviation | score on a scale | Day 0 ~ Month 48 (every 6 months ±6 weeks) |
|
|
|
| Secondary | Descriptive Statistics of Spinal Pain Score | Patient Assessment of Spinal Pain will be measured by VAS (0-100 mm) for EU patients and NRS (0-10) for Korea patients where higher scores indicates more severe pain. Descriptive statistics for actual value of Spinal Pain Score will be summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS will be transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more pain as assessed by the patient. | The Efficacy Analysis set consisted of all patients who received at least one infliximab dose (Remsima or Remicade) and providing at least one post treatment efficacy result during the analysis period. This study's primary objective is to compare RemsimaTM in patients with AS with patients receiving other anti-TNF drugs', especially with 'Remicade'. Therefore Switch to Remsima II" and "Switch to Other Anti-TNF" groups' are excluded from the results. | Posted | Mean | Standard Deviation | score on a scale | Day 0 ~ Month 48 (every 6 months ±6 weeks) |
|
|
|
| 1 |
| 124 |
| 14 |
| 124 |
| 50 |
| 124 |
| EG001 | Switch to Remsima I | Patients who switched from Remicade to Remsima were included in this analysis group | 0 | 23 | 1 | 23 | 9 | 23 |
| EG002 | Switch to Remsima II | Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group. | 0 | 10 | 2 | 10 | 9 | 10 |
| EG003 | Remicade | Patients who have received only Remicade were included in this analysis group. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG004 | Switch to Remicade I | Patients who switched from Remsima to Remicade were included in this analysis group. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG005 | Switch to Remicade II | Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | Other Anti-TNF | Following patients were included in other anti-TNF group.
| 0 | 146 | 11 | 146 | 43 | 146 |
| EG007 | Switch to Other Anti-TNF | Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group | 0 | 18 | 0 | 0 | 7 | 18 |
| Anal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Lip oedema | Gastrointestinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Sudden death | General disorders | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | Systematic Assessment |
|
| Hepatitis toxic | Hepatobiliary disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Peritonitis | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | Systematic Assessment |
|
| Pyelocystitis | Infections and infestations | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Obsessive-compulsive disorder | Psychiatric disorders | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Liver function test Increased | Investigations | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| OTORRHOEA | Ear and labyrinth disorders | Systematic Assessment |
|
| Uveitis | Eye disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Oedema peripheral | General disorders | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| C-reactive protein increased | Investigations | Systematic Assessment |
|
| Transminases increased | Investigations | Systematic Assessment |
|
| Hyperlipideamia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
|
| Month 12 |
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| Month 18 |
|
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| Month 24 |
|
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| Month 30 |
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| Month 36 |
|
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| Month 42 |
|
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| Month 48 |
|
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| Month 6 |
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| Month 12 |
|
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| Month 18 |
|
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| Month 24 |
|
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| Month 30 |
|
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| Month 36 |
|
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| Month 42 |
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| Month 48 |
|
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| Month 6 |
|
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| Month 12 |
|
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| Month 18 |
|
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| Month 24 |
|
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| Month 30 |
|
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| Month 36 |
|
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| Month 42 |
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| Month 48 |
|
|
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| Month 6 |
|
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| Month 12 |
|
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| Month 18 |
|
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| Month 24 |
|
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| Month 30 |
|
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| Month 36 |
|
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| Month 42 |
|
| Month 48 |
|
|
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| Month 6 |
|
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| Month 12 |
|
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| Month 18 |
|
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| Month 24 |
|
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| Month 30 |
|
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| Month 36 |
|
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| Month 42 |
|
| Month 48 |
|
|