A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis

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.

Study Overview

• Status: Unknown
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Drug: Fengshigutong Capsule plus Imrecoxib; Drug: Fengshigutong Capsule; Drug: Imrecoxib

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jieruo Gu, Prof; Phone Number: +8620-85252055; Email: gujieruo@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
      • Contact: Jieruo Gu, Prof; Phone Number: +8620-85252055; Email: gujieruo@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fengshigutong Capsule plus Imrecoxib; Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally	Drug: Fengshigutong Capsule plus Imrecoxib; Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
Experimental: Fengshigutong Capsule; Fengshigutong Capsule 1.2g twice a day,orally	Drug: Fengshigutong Capsule; Fengshigutong Capsule 1.2g twice a day,orally
Active Comparator: Imrecoxib; Imrecoxib 0.1g twice a day,orally	Drug: Imrecoxib; Imrecoxib 0.1g twice a day,orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the proportions of patients reaching Assessment in Ankylosing Spondylitis 20%	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)	4 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the proportions of patients reaching Assessment in Ankylosing Spondylitis 50%	defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)	4 week
ASAS20 response	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)	4 week
ASAS5/6 response	defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)	4 week

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Jieruo Gu, Prof, Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2016
• Primary Completion (Anticipated): May 31, 2019
• Study Completion (Anticipated): May 31, 2019

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: ankylosing spondylitis; Fengshigutong Capsule; imrecoxib
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: [2015]2-159

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No