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

Tracking Information
First Received Date ^ICMJE	April 27, 2009
Last Updated Date	April 27, 2009
Start Date ^ICMJE	October 2008
Estimated Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 27, 2009)	ASAS20 [ Time Frame: 12th week ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: April 27, 2009)	BASDAI20/50/70 [ Time Frame: 12th week ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Early Ankylosing Spondylitis
Intervention ^ICMJE	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.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	80
Estimated Completion Date	August 2009
Estimated Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00889694
Other Study ID Numbers ^ICMJE	[2008]2-4
Has Data Monitoring Committee	Yes
Responsible Party	Jieruo Gu, Rheumatology Department of Third Affiliated Hospital of Sun Yat-sen University
Study Sponsor ^ICMJE	Sun Yat-sen University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sun Yat-sen University
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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