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Study of Jitongning Tablet to Treat Spondyloarthritis

Primary Purpose

Spondyloarthritis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Jitongning tablet(High-dose )
Jitongning tablet(Low-dose )
Placebo
Sponsored by
Tasly Pharmaceutical Group Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondyloarthritis focused on measuring Jitongning Tablet, Spondyloarthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women aged 18 to 65 years old (including 18 and 65) ;

  • Meeting the diagnostic criteria for active axial SpA according to the the ASAS classification 2009, defined as satisfied 2 of the following:

    1. BASDAI score ≥ 4;
    2. In the assessment of pain numerical rating scale (NRS), spine pain NRS ≥ 4;
  • Meeting the standard of TCM syndrome diagnosis for kidney yang deficiency and biood stasis stagnating syndrome;
  • Sacroiliac arthritis of CT categories I(A)~Ⅲ(B) (including I(A) and Ⅲ(B));
  • Human leukocyte antigen B27 (HLA-B27) is positive;
  • C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate raised;
  • Voluntary signing of informed consent.

Exclusion Criteria:

  • Those who use NSAIDs in the first 2 weeks of randomization;
  • In the first 4 weeks of randomization, take disease-modifying antirheumatic Chinese herbal medicine or Chemical drugs (such as sulfasalazine ,methotrexate, leflunomide, Chloroquine, Total glycosides of Tripterygium, Cyclophosphamide, Azathioprine, etc),opioid analgesics(Methadone, Morphine, etc.) ,systemic glucocorticoid therapy;
  • In the first 3 months of randomization, take biological agents that have been used for spinal arthritis;
  • Those who have undergone spinal surgery or joint surgery within 8 weeks before randomization;
  • Patients who received intra-articular injection, spinal or paravertebral injection of corticosteroids within the first 6 months of randomization;
  • The spine is completely stiff (fused);
  • Any Other rheumatic immune system diseases or immunodeficiency syndromes such as ulcerative colitis, psoriasis, uveitis, etc.
  • Those who have a fertility requirement within 6 months;
  • Women during pregnancy and lactation;
  • Suspected or indeed drug use, substance abuse, alcoholism;
  • In the first 3 months of randomization, take the test or in progress;
  • Serious cardiovascular, Liver , kidney, brain, mental, neurological disorders that affect informed consent and/or adverse event expression or observation;
  • Abnormal liver function(the AST or ALT value is above the upper limit of the normal); Abnormal renal function (serum creatinine is above the upper limit of normal);
  • Due to other circumstances, the investigator considered it inappropriate for the participants.

Sites / Locations

  • The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • The First Affiliated Hospital of hunan Medical University
  • Jiangsu Province Hospital of Integrated Traditional Chinese and Western Medicine
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
  • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Kunming Medical University
  • Yunnan Province Hospital of Traditional Chinese Medicine
  • Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Jitongning tablet High dose group

Jitongning tablet Low dose group

Placebo Comparator controlled group

Arm Description

Jitongning tablet,3tablets,bid,po

Jitongning tablet,2tablets,bid,po Jitongning tablet placebo,1tablet,bid,po

Placebo Comparator: Jitongning tablet placebo,3tablets,bid,po

Outcomes

Primary Outcome Measures

ASAS 20 response
The percentage of subjects who achieved ASAS 20 response at 12th weeks

Secondary Outcome Measures

BASDAI
the score changes of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at each visit compared to baseline. This instrument consists of six 10cm horizontal visual analog scales to measure severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness (both qualitative and quantitative). The final BASDAI score has a range of 0 to 10. The mean of which gives the BASDAI score (0-10). The severity of patient's symptoms from 0 (none) to 10 (most severe).
BASFI
the score changes of Bath Ankylosing Spondylitis Functional Index (BASFI) at each visit compared to baseline. This instrument consists of 8 specific questions regarding function in AS and 2 questions reflecting the patient's ability to cope with everyday life. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10). The severity of patient's symptoms from 0 (none) to 10 (most severe).
Spinal pain
the score changes of Spinal pain at each visit compared to baseline. Spinal pain was scored as the average of two VAS questions about total spinal pain and nocturnal spinal pain. The mean of which gives the spinal pain score (0-10). The severity of patient's symptoms from 0 (none) to 10 (most severe).
PGA
the score changes of PGA at each visit compared to baseline. Patient global assessment was measured using a set of visual analogue scales (VAS) on which patients rated the severity of their disease from 0 (none) to 10 (most severe).
TCM syndrome scores
the score changes of TCM syndrome scores at each visit compared to baseline. This instrument consists of three primary symptoms: spinal pain, spinal function limited, morning stiffness and six secondary symptoms: nocturnal back pain、stabbing pain、Local cold pain、aversion to cold,preference for heat、heel pain、weakness in the lower back and knees. Four levels to measure severity of primary symptoms（0、2、4、6）and secondary symptoms（0、1、2、3）, respectively. Record the tongue and pulse conditions. The final score has a range of 0 to 100. The severity of patient's symptoms from 0 (none) to 100(most severe).The TCM syndrome effect calculated by nimodipine method. The effect of TCM syndrome from negative (worsen) to 100% (disappear).
CRP/hsCRP and ESR
the changes of CRP/hsCRP and ESR at each visit compared to baseline
Exposure of ibuprofen sustained release capsules
Exposure of ibuprofen sustained release capsules in test group and placebo at 12th weeks. Exposure of ibuprofen sustained release capsules refers to the quantity of ibuprofen capsules patient actually took. The difference between the total dispensed quantity and the sum of recycling quantity and missing quantity gives the exposure of ibuprofen sustained release capsules. The exposure of ibuprofen sustained release capsules from 0 (none) to 372 (maximum).

Full Information

First Posted
April 26, 2019
Last Updated
November 16, 2022
Sponsor
Tasly Pharmaceutical Group Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03932019
Brief Title
Study of Jitongning Tablet to Treat Spondyloarthritis
Official Title
A Randomized, Double-blind, Placebo-controled, Multi-center Phase II Clinical Trial for Evaluation of the Efficacy and Safety of Jitongning Tablet in Patients With Active Axial Spondyloarthritis(SpA)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
June 20, 2021 (Actual)
Study Completion Date
August 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Pharmaceutical Group Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to investigate the efficacy and safety of Jitongning Tablet in improving joint function and pain symptoms in active axial spondyloarthritis (SpA) patients and to explore the optimal dosage.
Detailed Description
Jitongning Tablet is a kind of traditional Chinese medicine(TCM), consists of Cortex Eucommiae, Duhuo(Radix Angelicae Pubescentis), Zhichuanwu(Radix Aconiti) , Rhizoma Corydalis, Radix Paeoniae Rubra, Radix Puerariae and Radix Glycyrrhizae. This study is being conducted to evaluate the efficacy and safety of Jitongning Tablet in patients with active axial spondyloarthritis (SpA) (Syndrome Of Kidney Yang Deficiency and Biood Stasis Stagnation), when compared with placebo and to explore the optimal dosage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis
Keywords
Jitongning Tablet, Spondyloarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Jitongning tablet High dose group
Arm Type
Experimental
Arm Description
Jitongning tablet,3tablets,bid,po
Arm Title
Jitongning tablet Low dose group
Arm Type
Experimental
Arm Description
Jitongning tablet,2tablets,bid,po Jitongning tablet placebo,1tablet,bid,po
Arm Title
Placebo Comparator controlled group
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator: Jitongning tablet placebo,3tablets,bid,po
Intervention Type
Drug
Intervention Name(s)
Jitongning tablet(High-dose )
Other Intervention Name(s)
Jitongning tablet,3tablets
Intervention Description
Jitongning tablet,3tablets,bid,treat 12 weeks
Intervention Type
Drug
Intervention Name(s)
Jitongning tablet(Low-dose )
Other Intervention Name(s)
Jitongning tablet,2tablets,Jitongning tablet placebo,1tablet,
Intervention Description
Jitongning tablet,2tablets,bid,treat 12 weeks Jitongning tablet placebo,1tablet,bid,treat 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Jitongning tablet placebo,3tablets
Intervention Description
Jitongning tablet placebo,3tablets,bid,treat 12 weeks
Primary Outcome Measure Information:
Title
ASAS 20 response
Description
The percentage of subjects who achieved ASAS 20 response at 12th weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
BASDAI
Description
the score changes of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at each visit compared to baseline. This instrument consists of six 10cm horizontal visual analog scales to measure severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness (both qualitative and quantitative). The final BASDAI score has a range of 0 to 10. The mean of which gives the BASDAI score (0-10). The severity of patient's symptoms from 0 (none) to 10 (most severe).
Time Frame
4 weeks,8weeks,12weeks
Title
BASFI
Description
the score changes of Bath Ankylosing Spondylitis Functional Index (BASFI) at each visit compared to baseline. This instrument consists of 8 specific questions regarding function in AS and 2 questions reflecting the patient's ability to cope with everyday life. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10). The severity of patient's symptoms from 0 (none) to 10 (most severe).
Time Frame
4 weeks,8weeks,12weeks
Title
Spinal pain
Description
the score changes of Spinal pain at each visit compared to baseline. Spinal pain was scored as the average of two VAS questions about total spinal pain and nocturnal spinal pain. The mean of which gives the spinal pain score (0-10). The severity of patient's symptoms from 0 (none) to 10 (most severe).
Time Frame
4 weeks,8weeks,12weeks
Title
PGA
Description
the score changes of PGA at each visit compared to baseline. Patient global assessment was measured using a set of visual analogue scales (VAS) on which patients rated the severity of their disease from 0 (none) to 10 (most severe).
Time Frame
4 weeks,8weeks,12weeks
Title
TCM syndrome scores
Description
the score changes of TCM syndrome scores at each visit compared to baseline. This instrument consists of three primary symptoms: spinal pain, spinal function limited, morning stiffness and six secondary symptoms: nocturnal back pain、stabbing pain、Local cold pain、aversion to cold,preference for heat、heel pain、weakness in the lower back and knees. Four levels to measure severity of primary symptoms（0、2、4、6）and secondary symptoms（0、1、2、3）, respectively. Record the tongue and pulse conditions. The final score has a range of 0 to 100. The severity of patient's symptoms from 0 (none) to 100(most severe).The TCM syndrome effect calculated by nimodipine method. The effect of TCM syndrome from negative (worsen) to 100% (disappear).
Time Frame
4 weeks,8weeks,12weeks
Title
CRP/hsCRP and ESR
Description
the changes of CRP/hsCRP and ESR at each visit compared to baseline
Time Frame
4 weeks,8weeks,12weeks
Title
Exposure of ibuprofen sustained release capsules
Description
Exposure of ibuprofen sustained release capsules in test group and placebo at 12th weeks. Exposure of ibuprofen sustained release capsules refers to the quantity of ibuprofen capsules patient actually took. The difference between the total dispensed quantity and the sum of recycling quantity and missing quantity gives the exposure of ibuprofen sustained release capsules. The exposure of ibuprofen sustained release capsules from 0 (none) to 372 (maximum).
Time Frame
12weeks

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: Men or women aged 18 to 65 years old (including 18 and 65) ; Meeting the diagnostic criteria for active axial SpA according to the the ASAS classification 2009, defined as satisfied 2 of the following: BASDAI score ≥ 4; In the assessment of pain numerical rating scale (NRS), spine pain NRS ≥ 4; Meeting the standard of TCM syndrome diagnosis for kidney yang deficiency and biood stasis stagnating syndrome; Sacroiliac arthritis of CT categories I(A)~Ⅲ(B) (including I(A) and Ⅲ(B)); Human leukocyte antigen B27 (HLA-B27) is positive; C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate raised; Voluntary signing of informed consent. Exclusion Criteria: Those who use NSAIDs in the first 2 weeks of randomization; In the first 4 weeks of randomization, take disease-modifying antirheumatic Chinese herbal medicine or Chemical drugs (such as sulfasalazine ,methotrexate, leflunomide, Chloroquine, Total glycosides of Tripterygium, Cyclophosphamide, Azathioprine, etc),opioid analgesics(Methadone, Morphine, etc.) ,systemic glucocorticoid therapy; In the first 3 months of randomization, take biological agents that have been used for spinal arthritis; Those who have undergone spinal surgery or joint surgery within 8 weeks before randomization; Patients who received intra-articular injection, spinal or paravertebral injection of corticosteroids within the first 6 months of randomization; The spine is completely stiff (fused); Any Other rheumatic immune system diseases or immunodeficiency syndromes such as ulcerative colitis, psoriasis, uveitis, etc. Those who have a fertility requirement within 6 months; Women during pregnancy and lactation; Suspected or indeed drug use, substance abuse, alcoholism; In the first 3 months of randomization, take the test or in progress; Serious cardiovascular, Liver , kidney, brain, mental, neurological disorders that affect informed consent and/or adverse event expression or observation; Abnormal liver function(the AST or ALT value is above the upper limit of the normal); Abnormal renal function (serum creatinine is above the upper limit of normal); Due to other circumstances, the investigator considered it inappropriate for the participants.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Liu
Organizational Affiliation
Tasly Group, Co. Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
The First Affiliated Hospital of hunan Medical University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jiangsu Province Hospital of Integrated Traditional Chinese and Western Medicine
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
City
Jinan
State/Province
Shandong
Country
China
Facility Name
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Yunnan Province Hospital of Traditional Chinese Medicine
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Jitongning Tablet to Treat Spondyloarthritis

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