临床试验公共管理平台 Clinical Trial Management Public Platform

Screening
Visit point No.1 - Baseline
Visit point No.2 - 4w
Visit point No.3 - 12w
Visit point No.4 - 24w
Visit point No.5 - 36w
Visit point No.6 - 48w
Concomitant medication/non-medication therapy
AE/SAE log
End-trial evaluation

1.Screening

General Information
Inclusion Criteria
Exclusion Criteria
Disease and Treatment History
Screening Period Data
Ankylosing Spondylitis Diagnosis Related Tests
Signature & Date

1.1.General Information

Name	LIZH
Sex	Male
Date of birth	1990-02-07 yyyy-mm-dd
Occupation	Unemployment
Informed consent form (signature page) (scan copy)	/uploads/patrecord/5589/param330415/39536da3-7e71-440a-a725-1800f4d07cc0.pdf

1.2.Inclusion Criteria

Inclusion Criterias	Yes / Yes / Yes / Yes

Inclusion Criterias

Yes

1.3.Exclusion Criteria

Other condition

不符合任一排除标准

1.4.Disease and Treatment History

First diagnosis of ankylosing spondylitis	2021-03 yyyy-mm
Features of diagnosed ankylosing spondylitis
Treatment history of AS(Within 3 months)	None
Other treatment
Specific drugs and its usage, treatment effcet
Other disease history	None
Other disease(if have)
Status of other disease
Other status
History of allergy	No
Allergic drugs or foods
History of surgeries
If Yes

1.6.Screening Period Data

1.1.6.、Blood Routine Test

	Abnormal but no clinical significance
Abnormal index
Managment of abnormal index

Abnormal but no clinical significance

Abnormal index

Managment of abnormal index

1.1.6.、Liver Function

	Abnormal but no clinical significance

Abnormal but no clinical significance

1.1.6.、Renal Function

	Abnormal but no clinical significance

Abnormal but no clinical significance

1.1.6.、HBV/HCV/HIV Screening

HBV、HCV、HIV Screening	/ / / / / /

HBV、HCV、HIV Screening

1.1.6.、ECG

Normal

2021-04-12 yyyy-mm-dd

1.1.6.、Chest X-ray

Chest X-ray	Abnormal with clinical significance
	强直性脊柱炎
	2021-04-12 yyyy-mm-dd

Chest X-ray

Abnormal with clinical significance

强直性脊柱炎

2021-04-12 yyyy-mm-dd

1.7.Ankylosing Spondylitis Diagnosis Related Tests

Previous inspection results (if have) (scan copy)

Previous inspection results (if have) (scan copy)

1.1.7.、HLA-B27

1.1.7.、Sacroiliac X-Ray

	/uploads/patrecord/5589/param323553/19c7d1d8-27ae-4f1a-b5e0-c9ab864087b9.jpg

/uploads/patrecord/5589/param323553/19c7d1d8-27ae-4f1a-b5e0-c9ab864087b9.jpg

1.1.7.、Acute Phase Reactants

C-reactive Protein	38.57 mg/l
ESR	35 mm/1h

1.8.Signature & Date

Signature	肖军
Date	2021-12-28 yyyy-mm-dd

2.Visit point No.1 - Baseline

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

2.1.Physical examination

	Not tested
Notes：

Not tested

Notes：

2.2.Laboratory Tests

For details, see section 1.6

For details, see section 1.6

2.3.BASDAI Score

	7
	6
	8
	8
	7
	4
	5.5
	6.9

2.4.Patient Global Score

2.5.ASDAS Score

	4.4

4.4

2.6.BASFI Score

	9
	7
	9
	8
	8
	8
	8
	8
	8
	7
	8

2.7.Sacroliac SPARCC MRI Score

Date of MR examination	yyyy-mm-dd
Presence of Sacroiliac arthritis in MR
Score in each slice
Slice 1
Basic score of intensity(maximum 8 score per slice)	分
Additional intensity score(maximum 2 score per slice)	分
Additional depth score(maximum 2 score per slice)	分
Slice 2
Basic score of intensity(maximum 8 score per slice)	分
Additional intensity score(maximum 2 score per slice)	分
Additional depth score(maximum 2 score per slice)	分
Slice 3
Basic score of intensity(maximum 8 score per slice)	分
Additional intensity score(maximum 2 score per slice)	分
Additional depth score(maximum 2 score per slice)	分
Slice 4
Basic score of intensity(maximum 8 score per slice)	分
Additional intensity score(maximum 2 score per slice)	分
Additional depth score(maximum 2 score per slice)	分

Basic score of intensity(maximum 8 score per slice)	分
Additional intensity score(maximum 2 score per slice)	分
Additional depth score(maximum 2 score per slice)	分
Slice 6
Basic score of intensity(maximum 8 score per slice)	分
Additional intensity score(maximum 2 score per slice)	分
Additional depth score(maximum 2 score per slice)	分
Total	分

2.8.SPARCC Score for the Sacroiliac Joint

Date of MR examination	yyyy-mm-dd
Five slices included in T1WSE
Score of erosion(maximum 40 scores)	分
Score of backfill(maximum 20 scores)	分
Score of fat metaplasia(maximum 40 scores)	分
Score of ankyosis(maximum 20 scores)	分

2.9.

EQ-5D-3L
	2
	1
	2
	2
	2
Score of E6 equals to section 2.4 Patient Global Score

2.10.

Total score(Details are listed in hard-copy CRF)	100 分
Upload raw data from online questionnaire platform	/uploads/patrecord/5589/param327781/e67e7785-f53e-4848-aa43-b42bd4247566.pdf

2.11.

2.2.11.2.11.1、Direct medical cost

Medicine cost
Drug category	csDMARDs
Drug cost	元
Drug category
Drug cost	元
Drug category
Drug cost	元
Other direct medical cost
Details	实验室检查
Cost	1547.12 元

2.2.11.2.11.2、Direct Non-medical Cost

Traffic fare	160 元
Accommodation cost	0 元
Catering cost	20 元
Other cost(listed in detail)
Cost	元

2.2.11.2.11.3、Indirect Cost

Daily salary of entourage(self report)	ND 元
Loss of working time(participant)	0 天
Daily salary of participant(self report)	0 元
Loss of working time(entourage)	0 天

2.12.Signature & Date

Signature	肖军
Date	2021-12-28 yyyy-mm-dd

3.Visit point No.2 - 4w

Date of visit	2021-06-07 yyyy-mm-dd
Whether participant quits trials	No
AE check	Yes
Check for drug combination	Yes
Physical Examination	Not tested
Remark

Laboratory Tests
Signature & Date

3.1.Laboratory Tests

	1.39 mg/L
	8 mm/1h
Liver function	Abnormal but no clinical significance
Remark
Renal function	Normal
Remark
Pelvic X-ray	/uploads/patrecord/5589/param329905/2e7d9c55-587d-483b-90d7-76f1a7e95bfa.jpg

3.2.








	1.5
	2.7

3.3.

3.4.

	1.5

1.5

3.5.











	2.2

3.6.

Date of MR examination	yyyy-mm-dd
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)
Additional intensity score(maximum 2 score per slice)
Additional depth score(maximum 2 score per slice)
Total
Additional intensity score(maximum 2 score per slice)

3.7.

Score of erosion(maximum 40 scores)
Score of backfill(maximum 20 scores)
Score of fat metaplasia(maximum 40 scores)
Score of ankyosis(maximum 20 scores)

3.8.

	1
	1
	2
	2
	2
E6 score equal with Patient Global score	3

3.9.

Total score(Details are listed in hard-copy CRF)	93
Upload raw data from online questionnaire platform	/uploads/patrecord/5589/param329750/ed875df9-04ae-46ca-a6fd-98928e002f2c.pdf

3.10.

3.11.

3.3.11.3.11.1、Direct medical cost

Medicine cost
Drug category	csDMARDs
Drug cost	504.28 元
Other direct medical cost
Details	实验室检查
Cost	1547.12 元
Cost	2625.44 元

3.3.11.3.11.2、Direct Non-medical Cost

Traffic fare	160 元
Accommodation cost	0 元
Catering cost	20 元
Other cost(listed in detail)
Cost	元

3.3.11.3.11.3、Indirect Cost

Loss of working time(participant)	0 天
Daily salary of participant(self report)	0 元
Loss of working time(entourage)	天
Daily salary of entourage(self report)	元

3.12.Signature & Date

Signature	肖军
Date	2021-12-28 yyyy-mm-dd

4.Visit point No.3 - 12w

Date of visit	2021-08-16 yyyy-mm-dd
Whether participant quits trials	No
AE check	Yes
Check for drug combination	Yes
Physical Examination	Not tested
Remark

Laboratory Tests
Economic indicators
Signature & Date

4.1.Laboratory Tests

	1.59 mg/L
	7 mm/1h
Liver function
Remark
Renal function
Remark
Pelvic X-ray	/uploads/patrecord/5589/param329910/1302a8b7-8e08-495e-b18b-f00967f1c0b5.jpg

4.2.







	0
	1.2

4.3.

4.4.

1.2 分

4.5.











	0

4.6.

Date of MR examination	yyyy-mm-dd
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)
Additional depth score(maximum 2 score per slice)
Total

4.7.

Date of MR examination	yyyy-mm-dd
Score of erosion(maximum 40 scores)
Score of backfill(maximum 20 scores)
Score of fat metaplasia(maximum 40 scores)
Score of ankyosis(maximum 20 scores)

4.8.

	1
	1
	2
	2
	1
E6 score equal with Patient Global score

4.9.

Total score(Details are listed in hard-copy CRF)
Upload raw data from online questionnaire platform

4.10.

4.11.Economic indicators

4.4.11.4.11.1、Direct medical cost

Medicine cost
Drug category	bDMARDs
Drug cost	5088 元
Drug category	csDMARDs
Drug cost	871.2 元
Other direct medical cost
Details

4.4.11.4.11.2、Direct Non-medical Cost

Traffic fare	160 元
Accommodation cost	0 元
Catering cost	0 元
Other cost(listed in detail)
Cost	元

4.4.11.4.11.3、Indirect Cost

Loss of working time(participant)	0 天
Daily salary of participant(self report)	0 元
Loss of working time(entourage)	0 天
Daily salary of entourage(self report)	ND 元

4.12.Signature & Date

Signature
Date	yyyy-mm-dd

5.Visit point No.4 - 24w

Date of visit	2021-12-17 yyyy-mm-dd
Whether participant quits trials	No
AE check	Yes
Check for drug combination	Yes
Physical Examination	Not tested
Remark

Laboratory Tests
Economic indicators
Signature & Date

5.1.Laboratory Tests

	0.41 mg/L
	5 mm/1h
Liver function	Abnormal but no clinical significance
Remark	AST/ALT
Renal function	Normal
Remark
Pelvic X-ray

5.2.







	0
	0.2

5.3.

5.4.

1.2

5.5.












	0

5.6.

Date of MR examination	yyyy-mm-dd
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)
Additional intensity score(maximum 2 score per slice)
Additional depth score(maximum 2 score per slice)
Total

5.7.

Date of MR examination	yyyy-mm-dd
Score of erosion(maximum 40 scores)
Score of backfill(maximum 20 scores)
Score of fat metaplasia(maximum 40 scores)
Score of ankyosis(maximum 20 scores)

5.8.

	1
	1
	1
	1
	1
E6 score equal with Patient Global score

5.9.

Total score(Details are listed in hard-copy CRF)	103
Upload raw data from online questionnaire platform	/uploads/patrecord/5589/param330083/9f2d13e1-29a1-4f82-a705-1d3485ff2e93.pdf

5.10.

5.11.Economic indicators

5.5.11.5.11.1、Direct medical cost

Medicine cost
Drug category	bDMARDs
Drug cost	7632 元
Drug category	csDMARDs
Drug cost	1306.8 元
Other direct medical cost
Details	实验室检查费用
Cost	235.76 元

5.5.11.5.11.2、Direct Non-medical Cost

Traffic fare	160 元
Accommodation cost	0 元
Catering cost	20 元
Other cost(listed in detail)
Cost	元

5.5.11.5.11.3、Indirect Cost

Loss of working time(participant)	0 天
Daily salary of participant(self report)	0 元
Loss of working time(entourage)	0 天
Daily salary of entourage(self report)	ND 元

5.12.Signature & Date

Signature
Date	yyyy-mm-dd

6.Visit point No.5 - 36w

Date of visit	yyyy-mm-dd
Whether participant quits trials
AE check
Check for drug combination
Physical Examination
Remark

Laboratory Tests
Economic indicators
Signature & Date

6.1.Laboratory Tests

	mg/L
	mm/1h
Liver function
Remark
Renal function
Remark
Pelvic X-ray

6.2.

6.3.

6.4.

6.5.

6.6.






E6 score equal with Patient Global score

6.7.

Total score(Details are listed in hard-copy CRF)
Upload raw data from online questionnaire platform

6.8.

6.9.Economic indicators

6.6.9.6.11.1、Direct medical cost

Medicine cost
Drug category
Drug cost	元
Drug category
Drug cost	元
Other direct medical cost
Details
Cost	元

6.6.9.6.11.2、Direct Non-medical Cost

Traffic fare	元
Accommodation cost	元
Catering cost	元
Other cost(listed in detail)
Cost	元

6.6.9.6.11.3、Indirect Cost

Loss of working time(participant)	天
Daily salary of participant(self report)	元
Loss of working time(entourage)	天
Daily salary of entourage(self report)	元

6.12.Signature & Date

Signature
Date	yyyy-mm-dd

7.Visit point No.6 - 48w

Date of visit	yyyy-mm-dd
Whether participant quits trials
AE check
Check for drug combination
Physical Examination
Remark

Laboratory Tests
Economic indicators
Signature & Date

7.1.Laboratory Tests

	mg/L
	mm/1h
Liver function
Remark
Renal function
Remark
Pelvic X-ray

7.2.

7.3.

7.4.

7.5.

7.6.

Date of MR examination	yyyy-mm-dd
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)
Additional intensity score(maximum 2 score per slice)
Additional depth score(maximum 2 score per slice)
Total

7.7.

Date of MR examination	yyyy-mm-dd
Score of erosion(maximum 40 scores)
Score of backfill(maximum 20 scores)
Score of fat metaplasia(maximum 40 scores)
Score of ankyosis(maximum 20 scores)

7.8.






E6 score equal with Patient Global score

7.9.

Total score(Details are listed in hard-copy CRF)
Upload raw data from online questionnaire platform

7.10.

7.11.Economic indicators

7.7.11.7.11.1、Direct medical cost

Medicine cost
Drug category
Drug cost	元
Drug category
Drug cost	元
Other direct medical cost
Details
Cost	元

7.7.11.7.11.2、Direct Non-medical Cost

Traffic fare	元
Accommodation cost	元
Catering cost	元
Other cost(listed in detail)
Cost	元

7.7.11.7.11.3、Indirect Cost

Loss of working time(participant)	天
Daily salary of participant(self report)	元
Loss of working time(entourage)	天
Daily salary of entourage(self report)	元

7.12.Signature & Date

Signature
Date	yyyy-mm-dd

8.Concomitant medication/non-medication therapy

Log 1
Note specific treatment measure (if it is drug, note the generic name and trade name)
Reasons for combined therapy
Dose
Start date	yyyy-mm-dd
End Date	yyyy-mm-dd
Cost of combined therapy	元
Whether combined therapy interfere this trial
Remark
Log 2
Note specific treatment measure (if it is drug, note the generic name and trade name)
Reasons for combined therapy
Dose and usage
Start date	yyyy-mm-dd
End Date	yyyy-mm-dd
Cost of combined therapy	元
Whether combined therapy interfere this trial
Remark
Log 3
Note specific treatment measure (if it is drug, note the generic name and trade name)
Reasons for combined therapy
Dose and usage
Start date	yyyy-mm-dd
End Date	yyyy-mm-dd
Cost of combined therapy	元
Whether combined therapy interfere this trial
Remark

9.AE/SAE log

Name of Adverse Event
Start date
End Date	yyyy-mm-dd
Severity evaluation
Measures to AE
Other measures
Connection to trial-related drugs

Outcomes of AEs

Remark to AE
Name of Adverse Event
Start date	yyyy-mm-dd
End Date	yyyy-mm-dd
Severity evaluation
Measures to AE
Other measures
Connection to trial-related drugs
Outcomes of AEs

Remark to AE

10.End-trial evaluation

Dose the participant finish the trial as planned
if No, note the last time of using trial-related drugs	yyyy-mm-dd
Reasons of incomplete
Remark
Review and Signature
I have reviwed all contents in CRF records and assure that they are intact and veritable, which fulfilled with clinical trial protocol.
Signature of trial conductor
Date	yyyy-mm-dd
CRA signature
Date	yyyy-mm-dd