Ankylosing Spondylitis
Conditions
Keywords
ankylosing spondylitis, Fengshigutong Capsule, imrecoxib
Brief summary
This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Fengshigutong Capsule in the treatment of active ankylosing spondylitis(AS). The primary purpose is to assess the different maintaining treatment programme in AS patients with controlled inflammation by Imrecoxib. The trial will include 180 patients who will be divided into three group: Fengshigutong Capsule plus Imrecoxib group, Imrecoxib group and Fengshigutong Capsule group. Patients will complete the 4-week therapy.
Interventions
DRUGFengshigutong Capsule plus Imrecoxib
Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
DRUGFengshigutong Capsule
Fengshigutong Capsule 1.2g twice a day,orally
DRUGImrecoxib
Imrecoxib 0.1g twice a day,orally
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 65 years * Meet 1984 modified New York criteria for AS * The Bath AS Disease Activity Index (BASDAI) ≥4 on a 0-10-cm visual analog scale or the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level (ASDAS-CRP) ≥1.3 * NSAIDs washout period of at least 7 days prior to randomization * DMARDs washout period of at least 4 weeks prior to randomization * Corticosteroids washout period of at least 2 weeks prior to randomization * Biological agents washout period of at least 3 months prior to randomization.
Exclusion criteria
* Peptic ulcer * Unstable cardiac diseases * Hematologic disorders * Psychosis * Malignancy * Multiple sclerosis * severe COPD * fibromyalgia and other rheumatic disease * Corticosteroids were injected into the articular cavity within 3 months * Chinese medicine was taken within 28 days * Pregnant and lactating women * Alcohol and drug abuse * Spinal cord compression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% | 4 week | ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the proportions of patients reaching Assessment in Ankylosing Spondylitis 50% | 4 week | defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP) |
| ASAS20 response | 4 week | ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI) |
| ASAS5/6 response | 4 week | defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP) |
Countries
China
Contacts
Primary ContactJieruo Gu, Prof
Outcome results
None listed