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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
  Purpose

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 Intervention Phase
Early Ankylosing Spondylitis
 Drug: Tripterygium
Drug: Sulfasalazine
Drug: placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • ASAS20 [ Time Frame: 12th week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BASDAI20/50/70 [ Time Frame: 12th week ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: April 27, 2009
Last Updated: April 27, 2009
Health Authority: China: Ethics Committee

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-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Infective Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013