- General Information
- Inclusion Criteria
- Exclusion Criteria
- Disease and Treatment History
- Screening Period Data
- Ankylosing Spondylitis Diagnosis Related Tests
- Signature & Date
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Name |
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Sex | |
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Date of birth | yyyy-mm-dd |
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Occupation | |
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Informed consent form (signature page) (scan copy) |
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Inclusion Criterias |
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Other condition |
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First diagnosis of ankylosing spondylitis | yyyy-mm |
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Features of diagnosed ankylosing spondylitis | |
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Treatment history of AS(Within 3 months) | |
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Other treatment |
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Specific drugs and its usage, treatment effcet |
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Other disease history | |
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Other disease(if have) |
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Status of other disease | |
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Other status |
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History of allergy | |
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Allergic drugs or foods |
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History of surgeries | |
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If Yes |
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Abnormal index |
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Managment of abnormal index |
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HBV、HCV、HIV Screening |
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yyyy-mm-dd |
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Chest X-ray | |
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yyyy-mm-dd |
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Previous inspection results (if have) (scan copy) |
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C-reactive Protein | mg/l |
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ESR | mm/1h |
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Signature |
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Date | yyyy-mm-dd |
- Physical examination
- Laboratory Tests
- BASDAI Score
- Patient Global Score
- ASDAS Score
- BASFI Score
- Sacroliac SPARCC MRI Score
- SPARCC Score for the Sacroiliac Joint
- Signature & Date
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Notes： |
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For details, see section 1.6 |
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Date of MR examination | yyyy-mm-dd |
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Presence of Sacroiliac arthritis in MR | |
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Score in each slice | |
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Slice 1 | |
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Basic score of intensity(maximum 8 score per slice) | 分 |
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Additional intensity score(maximum 2 score per slice) | 分 |
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Additional depth score(maximum 2 score per slice) | 分 |
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Slice 2 | |
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Basic score of intensity(maximum 8 score per slice) | 分 |
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Additional intensity score(maximum 2 score per slice) | 分 |
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Additional depth score(maximum 2 score per slice) | 分 |
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Slice 3 | |
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Basic score of intensity(maximum 8 score per slice) | 分 |
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Additional intensity score(maximum 2 score per slice) | 分 |
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Additional depth score(maximum 2 score per slice) | 分 |
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Slice 4 | |
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Basic score of intensity(maximum 8 score per slice) | 分 |
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Additional intensity score(maximum 2 score per slice) | 分 |
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Additional depth score(maximum 2 score per slice) | 分 |
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Basic score of intensity(maximum 8 score per slice) | 分 |
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Additional intensity score(maximum 2 score per slice) | 分 |
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Additional depth score(maximum 2 score per slice) | 分 |
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Slice 6 | |
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Basic score of intensity(maximum 8 score per slice) | 分 |
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Additional intensity score(maximum 2 score per slice) | 分 |
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Additional depth score(maximum 2 score per slice) | 分 |
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Total | 分 |
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Date of MR examination | yyyy-mm-dd |
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Five slices included in T1WSE | |
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Score of erosion(maximum 40 scores) | 分 |
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Score of backfill(maximum 20 scores) | 分 |
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Score of fat metaplasia(maximum 40 scores) | 分 |
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Score of ankyosis(maximum 20 scores) | 分 |
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EQ-5D-3L | |
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Score of E6 equals to section 2.4 Patient Global Score |
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Total score(Details are listed in hard-copy CRF) | 分 |
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Upload raw data from online questionnaire platform |
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Medicine cost | |
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Drug category | |
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Drug cost | 元 |
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Drug category | |
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Drug cost | 元 |
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Drug category | |
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Drug cost | 元 |
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Other direct medical cost | |
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Details |
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Cost | 元 |
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Traffic fare | 元 |
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Accommodation cost | 元 |
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Catering cost | 元 |
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Other cost(listed in detail) |
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Cost | 元 |
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Daily salary of entourage(self report) | 元 |
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Loss of working time(participant) | 天 |
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Daily salary of participant(self report) | 元 |
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Loss of working time(entourage) | 天 |
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Signature |
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Date | yyyy-mm-dd |
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Date of visit | 2021-05-21 yyyy-mm-dd |
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Whether participant quits trials | No
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AE check | Yes
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Check for drug combination | Yes
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Physical Examination | Not tested
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Remark |
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5.03 mg/L |
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6 mm/1h |
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Liver function | Abnormal but no clinical significance
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Remark |
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Renal function | Normal
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Remark |
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Pelvic X-ray | /uploads/patrecord/5589/param329905/8e29597d-f1b0-4da3-8ca6-fdcdf4a8f391.jpg |
1.5 |
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2.1 |
2 |
2.1 |
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Date of MR examination | yyyy-mm-dd |
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Inflammation in sacroliac joint | |
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Basic score of intensity(maximum 8 score per slice) |
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Additional intensity score(maximum 2 score per slice) |
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Additional depth score(maximum 2 score per slice) |
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Basic score of intensity(maximum 8 score per slice) |
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Additional intensity score(maximum 2 score per slice) |
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Additional depth score(maximum 2 score per slice) |
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Basic score of intensity(maximum 8 score per slice) |
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Additional intensity score(maximum 2 score per slice) |
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Additional depth score(maximum 2 score per slice) |
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Basic score of intensity(maximum 8 score per slice) |
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Additional intensity score(maximum 2 score per slice) |
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Additional depth score(maximum 2 score per slice) |
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Basic score of intensity(maximum 8 score per slice) |
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Additional intensity score(maximum 2 score per slice) |
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Additional depth score(maximum 2 score per slice) |
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Basic score of intensity(maximum 8 score per slice) |
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Additional intensity score(maximum 2 score per slice) |
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Additional depth score(maximum 2 score per slice) |
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Total |
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Additional intensity score(maximum 2 score per slice) |
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Score of erosion(maximum 40 scores) |
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Score of backfill(maximum 20 scores) |
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Score of fat metaplasia(maximum 40 scores) |
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Score of ankyosis(maximum 20 scores) |
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1 |
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1 |
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1 |
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2 |
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2 |
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E6 score equal with Patient Global score | 3 |
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Total score(Details are listed in hard-copy CRF) | 89 |
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Upload raw data from online questionnaire platform | /uploads/patrecord/5589/param329750/45c5539c-49c6-40fe-8e89-88dbc4daf12d.pdf |
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Medicine cost | |
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Drug category | bDMARDs
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Drug cost | 2544 元 |
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Other direct medical cost | |
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Details | 实验室检查费用 |
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Cost | 1078.32 元 |
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Cost | 元 |
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Traffic fare | 80 元 |
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Accommodation cost | 0 元 |
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Catering cost | 60 元 |
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Other cost(listed in detail) |
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Cost | 元 |
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Loss of working time(participant) | 1 天 |
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Daily salary of participant(self report) | 0 元 |
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Loss of working time(entourage) | 1 天 |
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Daily salary of entourage(self report) | 200 元 |
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Signature | 肖军 |
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Date | 2021-12-14 yyyy-mm-dd |
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Date of visit | 2021-08-13 yyyy-mm-dd |
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Whether participant quits trials | No
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AE check | Yes
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Check for drug combination | Yes
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Physical Examination | Not tested
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Remark |
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45.88 mg/L |
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46 mm/1h |
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Liver function | Abnormal but no clinical significance
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Remark | ALT,AST,AST/ALT，A/G |
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Renal function | Normal
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Remark |
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Pelvic X-ray | /uploads/patrecord/5589/param329910/9eae814f-5b4d-44a0-978f-68c726e0c122.jpg |
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分 |
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Date of MR examination | yyyy-mm-dd |
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Inflammation in sacroliac joint | |
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Basic score of intensity(maximum 8 score per slice) |
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Additional intensity score(maximum 2 score per slice) |
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|
Additional depth score(maximum 2 score per slice) |
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|
Basic score of intensity(maximum 8 score per slice) |
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|
Additional intensity score(maximum 2 score per slice) |
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|
Additional depth score(maximum 2 score per slice) |
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|
Basic score of intensity(maximum 8 score per slice) |
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|
Additional intensity score(maximum 2 score per slice) |
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Additional depth score(maximum 2 score per slice) |
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Basic score of intensity(maximum 8 score per slice) |
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Additional intensity score(maximum 2 score per slice) |
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Additional depth score(maximum 2 score per slice) |
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Basic score of intensity(maximum 8 score per slice) |
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Additional intensity score(maximum 2 score per slice) |
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Additional depth score(maximum 2 score per slice) |
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|
Basic score of intensity(maximum 8 score per slice) |
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Additional depth score(maximum 2 score per slice) |
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Total |
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Date of MR examination | yyyy-mm-dd |
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Score of erosion(maximum 40 scores) |
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Score of backfill(maximum 20 scores) |
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Score of fat metaplasia(maximum 40 scores) |
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Score of ankyosis(maximum 20 scores) |
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E6 score equal with Patient Global score |
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Total score(Details are listed in hard-copy CRF) | |
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Upload raw data from online questionnaire platform |
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Medicine cost | |
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Drug category | bDMARDs
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Drug cost | 5088 元 |
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Drug category | csDMARDs
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Drug cost | 871.2 元 |
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Other direct medical cost | |
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Details |
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Traffic fare | 80 元 |
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Accommodation cost | 0 元 |
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Catering cost | 60 元 |
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Other cost(listed in detail) |
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Cost | 元 |
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Loss of working time(participant) | 1 天 |
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Daily salary of participant(self report) | 0 元 |
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Loss of working time(entourage) | 1 天 |
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Daily salary of entourage(self report) | 200 元 |
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Signature |
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Date | yyyy-mm-dd |
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Date of visit | 2021-11-22 yyyy-mm-dd |
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Whether participant quits trials | No
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AE check | Yes
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Check for drug combination | Yes
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Physical Examination | Not tested
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Remark |
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9.43 mg/L |
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5 mm/1h |
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Liver function | Abnormal but no clinical significance
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Remark |
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Renal function | Normal
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Remark |
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Pelvic X-ray |
1 |
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1 |
1.7 |
0.1 |
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Date of MR examination | yyyy-mm-dd |
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Inflammation in sacroliac joint | |
|
Basic score of intensity(maximum 8 score per slice) |
|
|
Additional intensity score(maximum 2 score per slice) |
|
|
Additional depth score(maximum 2 score per slice) |
|
|
Basic score of intensity(maximum 8 score per slice) |
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|
Additional intensity score(maximum 2 score per slice) |
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|
Additional depth score(maximum 2 score per slice) |
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|
Basic score of intensity(maximum 8 score per slice) |
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|
Additional intensity score(maximum 2 score per slice) |
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|
Additional depth score(maximum 2 score per slice) |
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|
Basic score of intensity(maximum 8 score per slice) |
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|
Additional intensity score(maximum 2 score per slice) |
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|
Additional depth score(maximum 2 score per slice) |
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|
Basic score of intensity(maximum 8 score per slice) |
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|
Additional intensity score(maximum 2 score per slice) |
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Additional depth score(maximum 2 score per slice) |
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Basic score of intensity(maximum 8 score per slice) |
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|
Additional intensity score(maximum 2 score per slice) |
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Additional depth score(maximum 2 score per slice) |
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Total |
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Date of MR examination | yyyy-mm-dd |
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Score of erosion(maximum 40 scores) |
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Score of backfill(maximum 20 scores) |
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Score of fat metaplasia(maximum 40 scores) |
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Score of ankyosis(maximum 20 scores) |
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1 |
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1 |
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1 |
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1 |
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2 |
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E6 score equal with Patient Global score |
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Total score(Details are listed in hard-copy CRF) | 103 |
|
Upload raw data from online questionnaire platform | /uploads/patrecord/5589/param330083/1afeceab-14ca-417b-be57-2be81fb6bda2.pdf |
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Medicine cost | |
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Drug category | bDMARDs
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Drug cost | 7632 元 |
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Drug category | csDMARDs
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Drug cost | 1306.8 元 |
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Other direct medical cost | |
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Details | 实验室检查费用 |
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Cost | 1078.32 元 |
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Traffic fare | 80 元 |
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Accommodation cost | 0 元 |
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Catering cost | 60 元 |
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Other cost(listed in detail) |
|
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Cost | 元 |
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Loss of working time(participant) | 1 天 |
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Daily salary of participant(self report) | 0 元 |
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Loss of working time(entourage) | 1 天 |
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Daily salary of entourage(self report) | 200 元 |
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Signature | 肖军 |
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Date | 2021-12-14 yyyy-mm-dd |
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Date of visit | 2022-02-18 yyyy-mm-dd |
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Whether participant quits trials | No
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AE check | Yes
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Check for drug combination | Yes
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Physical Examination | Not tested
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Remark |
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94.18 mg/L |
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40 mm/1h |
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Liver function | Normal
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Remark |
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Renal function | Normal
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Remark |
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Pelvic X-ray | /uploads/patrecord/5589/param330136/f9aeb1e4-1938-4023-9358-861165dc1873.jpg |
1 |
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2.2 |
3.7 |
1.6 |
2 |
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2 |
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2 |
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2 |
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1 |
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E6 score equal with Patient Global score |
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Total score(Details are listed in hard-copy CRF) | 90 |
|
Upload raw data from online questionnaire platform | /uploads/patrecord/5589/param330463/b0005d1d-a139-48db-a61a-71acff4d6f47.pdf |
|
Medicine cost | |
|
Drug category | bDMARDs
|
|
Drug cost | 7632 元 |
|
Drug category | csDMARDs
|
|
Drug cost | 1306.8 元 |
|
Other direct medical cost | |
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Details | 实验室检查费用 |
|
Cost | 238.32 元 |
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Traffic fare | 80 元 |
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Accommodation cost | 0 元 |
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Catering cost | 60 元 |
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Other cost(listed in detail) |
|
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Cost | 元 |
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Loss of working time(participant) | 1 天 |
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Daily salary of participant(self report) | 0 元 |
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Loss of working time(entourage) | 1 天 |
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Daily salary of entourage(self report) | 200 元 |
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Signature |
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Date | yyyy-mm-dd |
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Date of visit | yyyy-mm-dd |
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Whether participant quits trials | |
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AE check | |
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Check for drug combination | |
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Physical Examination | |
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Remark |
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Date of MR examination | yyyy-mm-dd |
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Inflammation in sacroliac joint | |
|
Basic score of intensity(maximum 8 score per slice) |
|
|
Additional intensity score(maximum 2 score per slice) |
|
|
Additional depth score(maximum 2 score per slice) |
|
|
Basic score of intensity(maximum 8 score per slice) |
|
|
Additional intensity score(maximum 2 score per slice) |
|
|
Additional depth score(maximum 2 score per slice) |
|
|
Basic score of intensity(maximum 8 score per slice) |
|
|
Additional intensity score(maximum 2 score per slice) |
|
|
Additional depth score(maximum 2 score per slice) |
|
|
Basic score of intensity(maximum 8 score per slice) |
|
|
Additional intensity score(maximum 2 score per slice) |
|
|
Additional depth score(maximum 2 score per slice) |
|
|
Basic score of intensity(maximum 8 score per slice) |
|
|
Additional intensity score(maximum 2 score per slice) |
|
|
Additional depth score(maximum 2 score per slice) |
|
|
Basic score of intensity(maximum 8 score per slice) |
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|
Additional intensity score(maximum 2 score per slice) |
|
|
Additional depth score(maximum 2 score per slice) |
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Total |
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Date of MR examination | yyyy-mm-dd |
|
Score of erosion(maximum 40 scores) |
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Score of backfill(maximum 20 scores) |
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Score of fat metaplasia(maximum 40 scores) |
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|
Score of ankyosis(maximum 20 scores) |
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|
|
|
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E6 score equal with Patient Global score |
|
Total score(Details are listed in hard-copy CRF) |
|
|
Upload raw data from online questionnaire platform |
|
Medicine cost | |
|
Drug category | |
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Drug cost | 元 |
|
Drug category | |
|
Drug cost | 元 |
|
Other direct medical cost | |
|
Details |
|
|
Cost | 元 |
|
Traffic fare | 元 |
|
Accommodation cost | 元 |
|
Catering cost | 元 |
|
Other cost(listed in detail) |
|
|
Cost | 元 |
|
Loss of working time(participant) | 天 |
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Daily salary of participant(self report) | 元 |
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Loss of working time(entourage) | 天 |
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Daily salary of entourage(self report) | 元 |
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Signature |
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Date | yyyy-mm-dd |
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Log 1 | |
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Note specific treatment measure (if it is drug, note the generic name and trade name) |
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Reasons for combined therapy |
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Dose |
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Start date | yyyy-mm-dd |
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End Date | yyyy-mm-dd |
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Cost of combined therapy | 元 |
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Whether combined therapy interfere this trial | |
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Remark |
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Log 2 | |
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Note specific treatment measure (if it is drug, note the generic name and trade name) |
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Reasons for combined therapy |
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Dose and usage |
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Start date | yyyy-mm-dd |
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End Date | yyyy-mm-dd |
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Cost of combined therapy | 元 |
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Whether combined therapy interfere this trial | |
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Remark |
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Log 3 | |
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Note specific treatment measure (if it is drug, note the generic name and trade name) |
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Reasons for combined therapy |
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Dose and usage |
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Start date | yyyy-mm-dd |
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End Date | yyyy-mm-dd |
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Cost of combined therapy | 元 |
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Whether combined therapy interfere this trial | |
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Remark |
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Name of Adverse Event |
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Start date |
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End Date | yyyy-mm-dd |
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Severity evaluation | |
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Measures to AE | |
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Other measures |
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Connection to trial-related drugs | |
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Outcomes of AEs | |
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Remark to AE |
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Name of Adverse Event |
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Start date | yyyy-mm-dd |
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End Date | yyyy-mm-dd |
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Severity evaluation | |
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Measures to AE | |
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Other measures |
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Connection to trial-related drugs | |
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Outcomes of AEs | |
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Remark to AE |
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Dose the participant finish the trial as planned | |
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if No, note the last time of using trial-related drugs | yyyy-mm-dd |
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Reasons of incomplete | |
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Remark |
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Review and Signature | |
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I have reviwed all contents in CRF records and assure that they are intact and veritable, which fulfilled with clinical trial protocol. | |
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Signature of trial conductor |
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Date | yyyy-mm-dd |
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CRA signature |
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Date | yyyy-mm-dd |