Clinical trial NCT03932019: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spondyloarthritis
Keywords: Jitongning Tablet, Spondyloarthritis
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-04-30
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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.

Primary outcomes:
measure: ASAS 20 response
timeFrame: 12 weeks
Secondary outcomes:
measure: BASDAI
timeFrame: 4 weeks,8weeks,12weeks
measure: BASFI
timeFrame: 4 weeks,8weeks,12weeks
measure: Spinal pain
timeFrame: 4 weeks,8weeks,12weeks
measure: PGA
timeFrame: 4 weeks,8weeks,12weeks
measure: TCM syndrome scores
timeFrame: 4 weeks,8weeks,12weeks
measure: CRP/hsCRP and ESR
timeFrame: 4 weeks,8weeks,12weeks
measure: Exposure of ibuprofen sustained release capsules
timeFrame: 12weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
state: Anhui
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The First Affiliated Hospital of hunan Medical University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Integrated Traditional Chinese and Western Medicine
state: Jiangsu
city: Jinan
country: China
facility: Affiliated Hospital of Shandong University of Traditional Chinese Medicine
state: Shandong
city: Tianjin
country: China
facility: The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Tianjin
country: China
facility: The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Kunming
country: China
facility: Yunnan Province Hospital of Traditional Chinese Medicine
state: Yunnan
city: Shanghai
country: China
facility: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Study officials:
affiliation: Tasly Group, Co. Ltd.
name: Rui Liu
role: STUDY_DIRECTOR
References: