Early Ankylosing Spondylitis
Conditions
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.
Interventions
DRUGplacebo
Placebo: 2 capsules per time, 3 times per day for 12 weeks.
DRUGTripterygium
Tripterygium: 2 capsules per time, 3 times per day for 12 weeks.
DRUGSulfasalazine
Sulfasalazine: 0.75 gram per time, 2 times per day for 12 weeks.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Disease is in active status defined by BASDAI\>=40mm. 3. 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
1. Intra-articular injection of glucocorticoid within 3 months. 2. Previous history of heart failure, multiple sclerosis, chronic obstructive pulmonary disease, recurrent infection, lymphoma or other tumors. 3. Accompanied by fibromyalgia syndrome or other rheumatic diseases. 4. Female of pregnancy or breast-feeding. 5. Poor compliance or with mental diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS20 | 12th week |
Secondary
| Measure | Time frame |
|---|---|
| BASDAI20/50/70 | 12th week |
Outcome results
None listed