Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00889694
First received: April 27, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted

April 27, 2009
April 27, 2009
October 2008
July 2009   (final data collection date for primary outcome measure)
ASAS20 [ Time Frame: 12th week ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
BASDAI20/50/70 [ Time Frame: 12th week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Early Ankylosing Spondylitis
  • Drug: Tripterygium
    Tripterygium: 2 capsules per time, 3 times per day for 12 weeks.
  • Drug: Sulfasalazine
    Sulfasalazine: 0.75 gram per time, 2 times per day for 12 weeks.
  • Drug: placebo
    Placebo: 2 capsules per time, 3 times per day for 12 weeks.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
80
August 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00889694
[2008]2-4
Yes
Jieruo Gu, Rheumatology Department of Third Affiliated Hospital of Sun Yat-sen University
Sun Yat-sen University
Not Provided
Not Provided
Sun Yat-sen University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP