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Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT00889694
Recruitment Status : Unknown
Verified April 2009 by Sun Yat-sen University.
Recruitment status was:  Enrolling by invitation
First Posted : April 29, 2009
Last Update Posted : April 29, 2009
Sponsor:
Information provided by:
Sun Yat-sen University

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 Type : Interventional  (Clinical Trial)
Estimated 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 : October 2008
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    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.


Primary Outcome Measures :
  1. ASAS20 [ Time Frame: 12th week ]

Secondary Outcome Measures :
  1. BASDAI20/50/70 [ Time Frame: 12th week ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: Jieruo Gu, Rheumatology Department of Third Affiliated Hospital of Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00889694     History of Changes
Other Study ID Numbers: [2008]2-4
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Sulfasalazine
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents