Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00889694
• Collaborator: (none)
• Enrollment: 80
• Duration (Months): 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Early Ankylosing Spondylitis	Drug: Tripterygium; Drug: Sulfasalazine; Drug: placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2008
• Anticipated Primary Completion Date: Jul 1, 2009
• Anticipated Study Completion Date: Aug 1, 2009

Outcome Measures

Primary Outcome Measures

1. ASAS20 [12th week]

Secondary Outcome Measures

1. BASDAI20/50/70 [12th week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00889694
• Other Study ID Numbers: [2008]2-4
• First Posted: Apr 29, 2009
• Last Update Posted: Apr 29, 2009
• Last Verified: Apr 1, 2009

• Additional relevant MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Sulfasalazine

Study Results

No Results Posted as of Apr 29, 2009