Back to resultsThe Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients
Primary Purpose
Ankylosing Spondylitis
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Secukinumab 150 mg/ml
Adalimumab Ab
NSAID
Thalidomide Pill
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring secukinumab, adalimumab
Eligibility Criteria
Inclusion Criteria:
- Patients who meet modified New York 1984 criteria for ankylosing spondylitis；
- Age ≥18 years and ≤ 65 years；
- ASDAS ≥ 1.3；
- Concomitant drugs: use stable doses of NSAIDs alone for at least 4 weeks before the baseline period, stop other oral drugs such as methotrexate (MTX), sulfasalazine (SASP), glucocorticoids. Glucocorticoids can be injected locally after 12 weeks, NSAIDs keep stable for 12 weeks；
- Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent.
Exclusion Criteria:
Patients with severe infections, tumors and damage to vital organs:
- Platelet counts(PLT) <80 x 10^9 / L, or white blood cell (WBC) <3 x10^9 / L;
- Propionate acid aminotransferase (ALT) or aspartate aminotransferase(AST) is two times higher than the upper limit of normal;
- Renal insufficiency: serum Cr ≥ 176 umol / L;
- Pregnant or nursing women (breastfeeding) ;
- Patients has a history of malignancy (cure time in less than 5 years);
- Patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction;
- Patients with current or previous Crohn's disease;
- Patients with current ulcerative colitis requiring immunosuppressive therapy;
- Any active infection Active viral hepatitis includes hepatitis B virus (HBV), hepatitis C virus (HCV), human papillomavirus (HPV). Active infections include small intestine herpes zoster virus (VZV), human immunodeficiency virus (HIV), syphilis or tuberculosis;
- Patients who have received live vaccines within 4 weeks before randomization or plan to receive live vaccines during the trial;
- Patients who had inadequate response, intolerance or contraindication for both adalimumab and secukinumab.
Sites / Locations
- Qilu HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Randomized-SEC group
Randomized-ADA group
Non-Randomized-SEC group
Non-Randomized-ADA group
Arm Description
actived AS patients naïve to ADA and SEC
actived AS patients naïve to ADA and SEC
AS patients who previously had inadequate response to ADA
AS patients who previously had inadequate response to SEC
Outcomes
Primary Outcome Measures
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
Secondary Outcome Measures
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 20 Response
ASAS 20 response was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 units [on a scale of 0 to 10]) in the remaining domain:
Patient's global assessment of disease activity, measured on a NRS from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the BASFI which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related BASDAI NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response
ASAS 40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.
A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.
Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin])
The BASMI is a composite score based on 5 direct measurements of spinal mobility:
cervical rotation (measured in degrees), tragus to wall distance (in centimeters [cm]) lumbar side flexion (in cm), lumbar flexion (modified Schober's) (in cm) and intermalleolar distance (in cm). Each measurement is converted to a linear score between 0 and 10. The total BASMI score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.
Change From Baseline in ASAS Health Index (HI)
The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Change from Baseline in ESR, ESR will be measured with blood samples.
Change From Baseline in C-reactive Protein (CRP)
Change from Baseline in C-reactive Protein (CRP), a component index of ASDAS will be measured with blood samples.
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses.
modiifed stoke ankylosing spondylitis spine score (mSASSS)
modiifed stoke ankylosing spondylitis spine score ( range 0-72), a system for grading and evaluating cervical spine, lumbar spine, sacroiliac joint and hip joint by X-ray.
Dynamics of T Cell subset
T cell subsets, including cytotoxic T (Tc) cells, helper T (Th) cells
Full Information
NCT ID
NCT05527444
First Posted
May 6, 2022
Last Updated
August 30, 2022
Sponsor
Qilu Hospital of Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT05527444
Brief Title
The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients
Official Title
The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qilu Hospital of Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the clinical efficacy, safety and immunological changes of secukinumab(sec) compared to adalimumab(ada) in patients with active ankylosing spondylitis(AS), who previously have an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or bioagents.
Detailed Description
Biologic naïve participants will be randomly assigned in a 2:1 ratio to receive secukinumab or adalimumab for 24 weeks. Participants with a history of an inadequate response to secukinumab or adalimumab, will be treated with the alternative drug (adalimumab or secukinumab) for 24 weeks. The disease activity and index of inmunology will be evaluated at weeks 0, 12, 24 up to 96 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
secukinumab, adalimumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Randomized-SEC group
Arm Type
Experimental
Arm Description
actived AS patients naïve to ADA and SEC
Arm Title
Randomized-ADA group
Arm Type
Experimental
Arm Description
actived AS patients naïve to ADA and SEC
Arm Title
Non-Randomized-SEC group
Arm Type
Experimental
Arm Description
AS patients who previously had inadequate response to ADA
Arm Title
Non-Randomized-ADA group
Arm Type
Experimental
Arm Description
AS patients who previously had inadequate response to SEC
Intervention Type
Drug
Intervention Name(s)
Secukinumab 150 mg/ml
Other Intervention Name(s)
Secukinumab
Intervention Description
Secukinumab 150 mg will be administered at Baseline, Week 1, 2, 3, 4, 6, 8 followed by dosing every 4 weeks until Week 24
Intervention Type
Drug
Intervention Name(s)
Adalimumab Ab
Other Intervention Name(s)
Adalimumab
Intervention Description
adalimumab biosimilar 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 24
Intervention Type
Drug
Intervention Name(s)
NSAID
Intervention Description
stable dose
Intervention Type
Drug
Intervention Name(s)
Thalidomide Pill
Intervention Description
If patients have inadequate response to bioagents, thalidomide 50 mg will be administered at 12 week followed by dosing everyday until Week 24.
Primary Outcome Measure Information:
Title
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 20 Response
Description
ASAS 20 response was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 units [on a scale of 0 to 10]) in the remaining domain:
Patient's global assessment of disease activity, measured on a NRS from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the BASFI which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related BASDAI NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Time Frame
Baseline and Week 12, 24, 96
Title
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
Description
ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula:
Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 [none] - 10 [very severe]) Patient global assessment of disease activity (NRS score 0 [no activity] - 10 [severe activity]) Peripheral pain/swelling (BASDAI Question 3; NRS score 0 [none] - 10 [very severe]) Duration of morning stiffness (BASDAI Question 6; NRS score 0 [0 hours] - 10 [2 or more hours]) High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS < 1.3) and very high disease (ASDAS > 3.5). A negative change from Baseline score indicates improvement in disease activity.
Time Frame
Baseline and Week 24, 96
Title
Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response
Description
ASAS 40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units) in the potential remaining domain:
Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
Time Frame
Baseline and Week 12, 24, 96
Title
Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
Description
The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.
A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score.
Time Frame
Baseline and Week 12, 24, 96
Title
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Description
The Bath Ankylosing Spondylitis Functional Index is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities such as putting on socks, bending, reaching, getting up from the floor or an armless chair, standing, climbing and other physical activities. Each item is scored on a NRS ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher scores indicating more functional limitations. A negative change from Baseline in BASFI indicates improvement.
Time Frame
Baseline and Week 12, 24, 96
Title
Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin])
Description
The BASMI is a composite score based on 5 direct measurements of spinal mobility:
cervical rotation (measured in degrees), tragus to wall distance (in centimeters [cm]) lumbar side flexion (in cm), lumbar flexion (modified Schober's) (in cm) and intermalleolar distance (in cm). Each measurement is converted to a linear score between 0 and 10. The total BASMI score is the average of the 5 scores and ranges from 0 to 10; the higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis. A negative change from Baseline indicates improvement.
Time Frame
Baseline and Week 12, 24, 96
Title
Change From Baseline in ASAS Health Index (HI)
Description
The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. Each of the 17 questions is answered by the participant as "I agree" (score = 1) or "I disagree" (score = 0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, where a higher score indicates a worse health status. A negative change from Baseline indicates improvement.
Time Frame
Baseline and Week 12, 24, 96
Title
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Description
Change from Baseline in ESR, ESR will be measured with blood samples.
Time Frame
Baseline and Week 12, 24, 96
Title
Change From Baseline in C-reactive Protein (CRP)
Description
Change from Baseline in C-reactive Protein (CRP), a component index of ASDAS will be measured with blood samples.
Time Frame
Baseline and Week 12, 24, 96
Title
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Description
The MASES evaluation was conducted to assess the presence or absence of enthesitis (inflammation of the entheses, or sites where tendons or ligaments insert into the bone) at 13 different sites (first costochondral joint left/right, seventh costochondral joint left/right, posterior superior iliac spine left/right, anterior superior iliac spine left/right, iliac crest left/right, fifth lumbar spinous process, and proximal insertion of Achilles tendon left/right. Each site was scored for presence (1) or absence (0) of enthesitis. The MASES is the sum of the 13 site scores, and ranges from 0 to 13, with higher scores indicating more inflammation of the entheses.
Time Frame
Baseline and Week 12, 24, 96
Title
modiifed stoke ankylosing spondylitis spine score (mSASSS)
Description
modiifed stoke ankylosing spondylitis spine score ( range 0-72), a system for grading and evaluating cervical spine, lumbar spine, sacroiliac joint and hip joint by X-ray.
Time Frame
Baseline and Week 96
Title
Dynamics of T Cell subset
Description
T cell subsets, including cytotoxic T (Tc) cells, helper T (Th) cells
Time Frame
Baseline and Baseline and Week 12, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who meet modified New York 1984 criteria for ankylosing spondylitis；
Age ≥18 years and ≤ 65 years；
ASDAS ≥ 1.3；
Concomitant drugs: use stable doses of NSAIDs alone for at least 4 weeks before the baseline period, stop other oral drugs such as methotrexate (MTX), sulfasalazine (SASP), glucocorticoids. Glucocorticoids can be injected locally after 12 weeks, NSAIDs keep stable for 12 weeks；
Willing to participate in this study, willing to medication and follow-up according to the treatment plan, and sign the informed consent.
Exclusion Criteria:
Patients with severe infections, tumors and damage to vital organs:
Platelet counts(PLT) <80 x 10^9 / L, or white blood cell (WBC) <3 x10^9 / L;
Propionate acid aminotransferase (ALT) or aspartate aminotransferase(AST) is two times higher than the upper limit of normal;
Renal insufficiency: serum Cr ≥ 176 umol / L;
Pregnant or nursing women (breastfeeding) ;
Patients has a history of malignancy (cure time in less than 5 years);
Patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction;
Patients with current or previous Crohn's disease;
Patients with current ulcerative colitis requiring immunosuppressive therapy;
Any active infection Active viral hepatitis includes hepatitis B virus (HBV), hepatitis C virus (HCV), human papillomavirus (HPV). Active infections include small intestine herpes zoster virus (VZV), human immunodeficiency virus (HIV), syphilis or tuberculosis;
Patients who have received live vaccines within 4 weeks before randomization or plan to receive live vaccines during the trial;
Patients who had inadequate response, intolerance or contraindication for both adalimumab and secukinumab.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu Qiang, Dr.
Phone
0086-0531-82169654
Email
shuqiang@sdu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Sun Shuning
Phone
0086-0531-82169654
Email
897871565@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Xiaoyun, Dr.
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Study Director
Facility Information:
Facility Name
Qilu Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Xiaoyun
Phone
+8653182169035
Email
qlyykyc@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients
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