Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis

Early Ankylosing Spondylitis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00889694
• Other study ID #: [2008]2-4
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: April 27, 2009
• Last updated: April 27, 2009
• Start date: October 2008
• Est. completion date: August 2009

Study information

• Verified date: April 2009
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Early Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Tripterygium
Tripterygium: 2 capsules per time, 3 times per day for 12 weeks.
• Sulfasalazine
Sulfasalazine: 0.75 gram per time, 2 times per day for 12 weeks.
• placebo
Placebo: 2 capsules per time, 3 times per day for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASAS20		12th week	No
Secondary	BASDAI20/50/70		12th week	No