Back to resultsTotal Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy
Primary Purpose
Ankylosing Spondylitis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Total Glucosides Paeony Capsules
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis
Eligibility Criteria
Inclusion Criteria:
- Aged from 16-65 years, sign the Informed Consent
- Fulfill 1984 modified NewYork classification criteria for AS
- Achieved clinical remission after at least 12 weeks' therapy of anti-TNF therapy
- Hb≥9g/dl, ALT/AST≤ 2 folds of upper level normal range, creatine≤120mol/L(≤1.4mg/dl)
- Commitment to contraceptive for woman
Exclusion Criteria:
- History of psoriasis and/or inflammatory bowel diseases
- Receive intra-articular injection of cortisone within 3 months before enrollment
- History of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis
- Pregnant and lactating women
- Mentally ill, Alcoholics and drug addicts
Sites / Locations
- Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
- Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Total Glucosides Paeony, Capsules
no intervention
Arm Description
Outcomes
Primary Outcome Measures
the proportion of patients which disease activity reaches relapse criteria
Secondary Outcome Measures
BASDAI score comparing to baseline
BASFI score comparing to baseline
Full Information
NCT ID
NCT01517620
First Posted
January 15, 2012
Last Updated
December 12, 2013
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01517620
Brief Title
Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a prospective, randomized, open-label clinical trial to evaluate the efficacy and safety of total glucosides paeony capsules in maintaining clinical remission in patients with ankylosing spondylitis which achieved clinical remission after anti-TNF therapy. Patients will be divided into two groups randomly, one group receive non-steroid anti-inflammatory drugs(NSAID) mono-therapy and the other group receive total glucosides paeony capsules plus NSAID therapy for 24 weeks. The primary clinical endpoint is the proportion of patients which disease activity reaches relapse criteria. The investigator's hypothesis the proportion of relapse in total glucosides paeony capsules plus NSAID group would be lower than the NSAID mono-therapy group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Total Glucosides Paeony, Capsules
Arm Type
Experimental
Arm Title
no intervention
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Total Glucosides Paeony Capsules
Intervention Description
Total Glucosides Paeony Capsules, oral, 0.3 gram per capsule, 3 capsules tid, 24 weeks
Primary Outcome Measure Information:
Title
the proportion of patients which disease activity reaches relapse criteria
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
BASDAI score comparing to baseline
Time Frame
24 weeks
Title
BASFI score comparing to baseline
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged from 16-65 years, sign the Informed Consent
Fulfill 1984 modified NewYork classification criteria for AS
Achieved clinical remission after at least 12 weeks' therapy of anti-TNF therapy
Hb≥9g/dl, ALT/AST≤ 2 folds of upper level normal range, creatine≤120mol/L(≤1.4mg/dl)
Commitment to contraceptive for woman
Exclusion Criteria:
History of psoriasis and/or inflammatory bowel diseases
Receive intra-articular injection of cortisone within 3 months before enrollment
History of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis
Pregnant and lactating women
Mentally ill, Alcoholics and drug addicts
Facility Information:
Facility Name
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
Country
China
12. IPD Sharing Statement
Learn more about this trial
Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy
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