Back to resultsClinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis
Primary Purpose
Early Ankylosing Spondylitis
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tripterygium
Sulfasalazine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Early Ankylosing Spondylitis
Eligibility Criteria
Inclusion Criteria:
- Fulfill the ESSG criteria for SpA and not fulfill any criteria for the subtype including ankylosing spondylitis, psoriatic arthritis, reactive arthritis and inflammatory bowel disease associated arthritis.
- Disease is in active status defined by BASDAI>=40mm.
- DMARDs administration must be suspended for at least 4 weeks before screening. NSAIDs dose must be stable for at least 4 weeks before screening.
Exclusion Criteria:
- Intra-articular injection of glucocorticoid within 3 months.
- Previous history of heart failure, multiple sclerosis, chronic obstructive pulmonary disease, recurrent infection, lymphoma or other tumors.
- Accompanied by fibromyalgia syndrome or other rheumatic diseases.
- Female of pregnancy or breast-feeding.
- Poor compliance or with mental diseases.
Sites / Locations
Outcomes
Primary Outcome Measures
ASAS20
Secondary Outcome Measures
BASDAI20/50/70
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00889694
Brief Title
Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis
Official Title
Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis: a 12-Week, Multiple Centers, Randomized Double-Blind, Positive Drug and Placebo Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
August 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a 12-week, randomized, placebo and positive drug controlled clinical trial to investigate whether tripterygium capsule is effective and safe in treating patients with ankylosing spondylitis. The investigators expect that the tripterygium capsule is more effective than placebo and has few adverse effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Ankylosing Spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tripterygium
Intervention Description
Tripterygium: 2 capsules per time, 3 times per day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Sulfasalazine
Intervention Description
Sulfasalazine: 0.75 gram per time, 2 times per day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo: 2 capsules per time, 3 times per day for 12 weeks.
Primary Outcome Measure Information:
Title
ASAS20
Time Frame
12th week
Secondary Outcome Measure Information:
Title
BASDAI20/50/70
Time Frame
12th week
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:
Fulfill the ESSG criteria for SpA and not fulfill any criteria for the subtype including ankylosing spondylitis, psoriatic arthritis, reactive arthritis and inflammatory bowel disease associated arthritis.
Disease is in active status defined by BASDAI>=40mm.
DMARDs administration must be suspended for at least 4 weeks before screening. NSAIDs dose must be stable for at least 4 weeks before screening.
Exclusion Criteria:
Intra-articular injection of glucocorticoid within 3 months.
Previous history of heart failure, multiple sclerosis, chronic obstructive pulmonary disease, recurrent infection, lymphoma or other tumors.
Accompanied by fibromyalgia syndrome or other rheumatic diseases.
Female of pregnancy or breast-feeding.
Poor compliance or with mental diseases.
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis
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