Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis

April 27, 2009 updated by: Sun Yat-sen University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ASAS20
Time Frame: 12th week
12th week

Secondary Outcome Measures

Outcome Measure
Time Frame
BASDAI20/50/70
Time Frame: 12th week
12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Anticipated)

July 1, 2009

Study Completion (Anticipated)

August 1, 2009

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (Estimate)

April 29, 2009

Study Record Updates

Last Update Posted (Estimate)

April 29, 2009

Last Update Submitted That Met QC Criteria

April 27, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2008]2-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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